RESEARCH UNITS ON PEDIATRIC PSYCHOPHARMACOLOGY--AUTISM
James T Mccracken, Joseph Campbell Professor Of Child Psych
University Of California Los Angeles Office Of Research Administration Los Angeles, Ca 90095
Grant 3N01MH070010-00197 from National Institute Of Mental Health
Abstract: The purpose of the contract is to 1) establish qualified clinical research units that, by building of existing research resources at the host Institution and combining the necessary expertise in clinical pharmacology and child psychiatry, can become national resources where studies ont he safety and efficacy of psychotropic medications can be conducted in a prompt and cost effective manner; and 2) fund selected research projects of particular public health significance, in particular in the area of autism and other pervasive developmental disorders, to be conducted at these units. The units, together with the already funded RUPPs will work as a network of research sites and conduct high priority clinical studies in various pediatric ages, conducting research on various aspects of pediatric psychopharmacology, including (but not limited to) dose ranges, dosing regimen, pharmacokinetics, general safety profile, efficacy and effectiveness, and effects on cognition, behavior and development. To establish research units of where clinical studies on the safety, efficacy, pharmacokinetics and pharmacodynamics of psychotropic medications can be investigated in children and adolescents, in general, and in patients suffering from autism and other pervasive developmental disorders in particular. To conduct a minimum of 2 studies at each research unit (of which one shall be a clinical efficacy trial and the other a pharmacokinetic and/or pharmacodynamic dose finding study or a pilot efficacy and tolerability study) during the 3 years of the contract. In addition, if the two year option is exercised, at least another two similar studies (i.e., one efficacy trial and one pharmacokinetic and/or pharmacodynamic dose finding study) shall be conducted. To spur the conduct of other clinical trials and studies in pediatric psychopharmacology to be funded through mechanisms other than this contract (i.e., investigator-initiated grants from federal agencies, private foundations, and pharmaceutical companies).
Keywords: autism, child mental disorder, drug screening /evaluation, human therapy evaluation, mental disorder chemotherapy, pediatric pharmacology, psychopharmacology, adolescence (12-18), child (0-11), clinical trial, dosage, clinical research, human subject
Project start date: 1997-09-30
Project end date: 2000-09-30
Sponsored Links Excellgen http://Excellgen.com
RESEARCH UNITS ON PEDIATRIC PSYCHOPHARMACOLOGY--AUTISM
James T Mccracken, Joseph Campbell Professor Of Child Psych
University Of California Los Angeles Office Of Research Administration Los Angeles, Ca 90095
Grant 3N01MH070010-004 from National Institute Of Mental Health
Abstract: The purpose of the contract is to 1) establish qualified clinical research units that, by building of existing research resources at the host Institution and combining the necessary expertise in clinical pharmacology and child psychiatry, can become national resources where studies ont he safety and efficacy of psychotropic medications can be conducted in a prompt and cost effective manner; and 2) fund selected research projects of particular public health significance, in particular in the area of autism and other pervasive developmental disorders, to be conducted at these units. The units, together with the already funded RUPPs will work as a network of research sites and conduct high priority clinical studies in various pediatric ages, conducting research on various aspects of pediatric psychopharmacology, including (but not limited to) dose ranges, dosing regimen, pharmacokinetics, general safety profile, efficacy and effectiveness, and effects on cognition, behavior and development. To establish research units of where clinical studies on the safety, efficacy, pharmacokinetics and pharmacodynamics of psychotropic medications can be investigated in children and adolescents, in general, and in patients suffering from autism and other pervasive developmental disorders in particular. To conduct a minimum of 2 studies at each research unit (of which one shall be a clinical efficacy trial and the other a pharmacokinetic and/or pharmacodynamic dose finding study or a pilot efficacy and tolerability study) during the 3 years of the contract. In addition, if the two year option is exercised, at least another two similar studies (i.e., one efficacy trial and one pharmacokinetic and/or pharmacodynamic dose finding study) shall be conducted. To spur the conduct of other clinical trials and studies in pediatric psychopharmacology to be funded through mechanisms other than this contract (i.e., investigator-initiated grants from federal agencies, private foundations, and pharmaceutical companies).
Keywords: autism, child mental disorder, drug screening /evaluation, human therapy evaluation, mental disorder chemotherapy, pediatric pharmacology, psychopharmacology, adolescence (12-18), child (0-11), clinical trial, dosage, clinical research, human subject
Grants awarded to James T Mccracken
SLEEP AND HORMONE REGULATION IN JUVENILE DEPRESSION
James T Mccracken, Joseph Campbell Professor Of Child Psych
La Biomed Res Inst/ Harbor Ucla Med Ctr Torrance, Ca 90502
Grant 2M01RR000425-23A10412 from National Center For Research Resources
Abstract: To investigate possible sleep and hormonal abnormalities in juvenile depression. Dexamethasone suppression, thyrotropin releasing hormone (TRH) stimulation and scopolamine challenge tests will be performed in depressive patients and normal age matched controls.
Keywords: child (0-11), clinical depression, hormone regulation /control mechanism, sleep, scopolamine, thyrotropin releasing hormone, dexamethasone suppression test, human clinical subject
HORMONE RHYTHMS--METABOLIC SIGNIFICANCE IN DEPRESSION
James T Mccracken, Joseph Campbell Professor Of Child Psych
La Biomed Res Inst/ Harbor Ucla Med Ctr Torrance, Ca 90502
Grant 5M01RR000425-240448 from National Center For Research Resources
Abstract: To assess the utility of sleep stage measures and endocrine testing as an aid in the differential diagnosis of depressive disorders, and to investigate hypothalamo-pituitary-adrenal cortical axis dysregulation.
Keywords: bioperiodicity, depression, hormone metabolism, mental disorder diagnosis, sleep, brain pathway /tract, endocrine disorder, hypothalamic pituitary axis, pituitary adrenal axis, human subject
James T Mccracken, Professor
University Of California Los Angeles, Office Of Research Administration, Los Angeles, Ca 90095
Grant 5U01MH060900-08 from National Institute Of Mental Health
Abstract: This revised resubmission of a six-site follow-up proposal requests funding for a five year study of the safety of methylphenidate (MPH) in children who had been originally recruited and randomized into the preschool Attention-Deficit / Hyperactivity Disorder (ADHD) treatment study (PATS). We propose to continue our multi-site collaboration to conduct a systematic follow-up study of the children who were diagnosed with ADHD in preschool years (ages 3-5 years) and participated in the original Preschoolers with ADHD Treatment Study (PATS) to determine the safety and efficacy of methylphenidate. The proposed follow-up study will assess these children as they turn 4-9 years of age. It will be based at the New York State Psychiatric Institute (NYSPI), Duke University, Johns Hopkins University (JHU), New York University (NYU), University of California at Los Angeles (UCLA), and University of California at Irvine (UCI). The Primary Aim is to address whether early treatment with MPH is associated with emergence of any negative physical (decreased height and weight growth rates), cognitive, or behavioral (e.g., sleep disturbance, tics) effects. The Secondary Aim is to collect information on the course of psychopathology and functioning of the PATS children
Keywords: 0-11 years old; 1-5 years old; 2-Piperidineacetic acid, alpha-phenyl-, methyl ester; AD/HD; ADHD; Accounting; Active Follow-up; Address; Adverse Experience; Adverse effects; Adverse event; Age; Age-Years; Appearance; Attention deficit hyperactivity disorder; Attention-Deficit Disorder, Predominantly Hyperactive-Impulsive Type; Behavior Conditioning Therapy; Behavior Modification; Behavior Therapy; Behavior Treatment; Behavior or Life Style Modifications; Behavioral; Behavioral Conditioning Therapy; Behavioral Modification; Behavioral Therapy; Behavioral Treatment; California; Child; Child Youth; Child, Preschool; Children (0-21); Classification; Cognitive; Collaborations; Collection; Comorbidity; Conditioning Therapy; Daily; Data; Depression; Development; Diagnosis; Dose; Drugs; Early treatment; Exposure to; Family; Follow-Up Studies; Followup Studies; Funding; Gender; Generalized Growth; Goals; Grant; Growth; Height; Human, Child; Hyperactive behavior; Hyperactivity; Hyperactivity Disorder NOS; Hyperactivity Disorder, Predominantly Hyperactive-Impulsive Type; Hyperactivity, Motor; Hyperkinesia; Hyperkinesis; Hyperkinetic Movements; Hyperkinetic Syndrome; Institutes; Life Style Modification; Los Angeles; Measures; Medication; Mental Depression; Methylphenidate; NIMH; National Institute of Mental Health; National Institute of Mental Health (U.S.); New York; Numbers; Nursery Schools; Parents; Personal Satisfaction; Pharmaceutic Preparations; Pharmaceutical Preparations; Phase; Preschool Child; Psychopathology; Psychoses; Psychosocial Factor; Psychotic Disorders; Purpose; RFP; Randomized; Rate; Recruitment Activity; Relative; Relative (related person); Request for Proposals; Safety; Sampling; Sampling Studies; Schools, Nursery; Score; Severities; Site; Sleep Disorders; Sleep disturbances; Social Environment; Symptoms; Systematics; Time; Tissue Growth; Treatment Period; Treatment Side Effects; United States National Institute of Mental Health; Universities; Weight; abnormal psychology; attention deficit hyperactive disorder; base; behavior intervention; behavioral intervention; children; drug/agent; early onset; elementary school; follow-up; ontogeny; peer; preschool child (1-5); prospective; psychopharmacologic; psychopharmacological; psychosocial variables; randomisation; randomization; randomly assigned; recruit; response; side effect; sleep problem; social climate; social context; socioenvironment; therapy adverse effect; treatment adverse effect; treatment days; treatment duration; well-being; youngster
Project start date: 1999-12-01
Project end date: 2010-05-31
Budget start date: 8-SEP-2008
Budget end date: 31-MAY-2010
5U01MH060900-08 (2008): $0
5U01MH060900-07 (2007): $64283
5U01MH060900-06 (2006): $69224
Sponsored Links Excellgen http://Excellgen.com
5U01MH060900-05 (2005): $64157
2U01MH060900-04A1 (2004): $66673
TRAINING THE SCIENCE OF CHILD MENTAL HEALTH TREATMENT
James T Mccracken, Professor
University Of California Los Angeles, Office Of Research Administration, Los Angeles, Ca 90095
Grant 5T32MH073517-05 from National Institute Of Mental Health
Abstract: This revised proposal for a new Institutional National Research Service Award (T32) is designed to provide interdisciplinary research training to predoctoral and postdoctoral level young investigators in the broad area of child mental health treatment research. Trainees will identify specific areas of mental illness and chose research strategies that advance such research at a variety of levels-treatment mechanisms, efficacy study methodology, and applications. General goals for the trainees will be to obtain a broad background in current issues in child mental health treatment research; appreciate relevant basic science models and approaches; develop expertise in a scientific method for application to studies of child treatment; complete significant independent research in a designated area of research; and develop skills necessary for transitioning into an independent investigator. This program will form a nexus for training in issues pertaining to treatment of developmental psychopathologies which currently does not exist in the region. Research training will occur at the translational intersection of disorder-specific areas-child anxiety, ADHD and disruptive disorders, autism spectrum disorders, mood disorders and suicide, and neuropsychiatric disorders-with examination of levels of treatment, such as mechanisms or biomarkers of treatment, efficacy study methods, or application of treatment research. The core training experience will occur within the trainee´s own research and in their close interaction with a preceptor. In addition, participation in core didactic coursework and supplementary coursework and experiences will provide broad and specific knowledge in research approaches. The combination of trainees focusing on basic and applied research will broaden research perspectives and prepare trainees for work in collaborative research projects. The proposed plan consists of training 5 postdoctoral students with medical or doctoral degrees and 2 predoctoral students. Postdoctoral trainees will possess clinical training in a discipline relevant to child mental health treatment, or plan to complete such training following the conclusion of the research training period. Predoctoral students will be drawn from Departments of Psychology, Education, Neuroscience, or Nursing at UCLA. The program will benefit from the breadth of active treatment research at UCLA and from the supplemental cross-disciplinary training available from a wide variety of departments, programs, research units, and other training activities
Keywords: Child Mental Health; Science; Training
Project start date: 2006-06-01
Project end date: 2011-05-31
Budget start date: 1-JUN-2010
Budget end date: 31-MAY-2011
PFA/PA: PA-02-109
5T32MH073517-05 (2010): $127217
5T32MH073517-04 (2009): $100942
3T32MH073517-04S1 (2009): $105045
Research Training: The Science Of Child Mental Health Treatment
James T Mccracken, Joseph Campbell Professor Of Child Psych
University Of California Los Angeles Office Of Research Administration Los Angeles, Ca 90095
Grant 5T32MH073517-02 from National Institute Of Mental Health IRG: ZMH1
Abstract: This revised proposal for a new Institutional National Research Service Award (T32) is designed to provide interdisciplinary research training to predoctoral and postdoctoral level young investigators in the broad area of child mental health treatment research. Trainees will identify specific areas of mental illness and chose research strategies that advance such research at a variety of levels-treatment mechanisms, efficacy study methodology, and applications. General goals for the trainees will be to obtain a broad background in current issues in child mental health treatment research; appreciate relevant basic science models and approaches; develop expertise in a scientific method for application to studies of child treatment; complete significant independent research in a designated area of research; and develop skills necessary for transitioning into an independent investigator. This program will form a nexus for training in issues pertaining to treatment of developmental psychopathologies which currently does not exist in the region. Research training will occur at the translational intersection of disorder-specific areas-child anxiety, ADHD and disruptive disorders, autism spectrum disorders, mood disorders and suicide, and neuropsychiatric disorders-with examination of levels of treatment, such as mechanisms or biomarkers of treatment, efficacy study methods, or application of treatment research. The core training experience will occur within the trainee s own research and in their close interaction with a preceptor. In addition, participation in core didactic coursework and supplementary coursework and experiences will provide broad and specific knowledge in research approaches. The combination of trainees focusing on basic and applied research will broaden research perspectives and prepare trainees for work in collaborative research projects. The proposed plan consists of training 5 postdoctoral students with medical or doctoral degrees and 2 predoctoral students. Postdoctoral trainees will possess clinical training in a discipline relevant to child mental health treatment, or plan to complete such training following the conclusion of the research training period. Predoctoral students will be drawn from Departments of Psychology, Education, Neuroscience, or Nursing at UCLA. The program will benefit from the breadth of active treatment research at UCLA and from the supplemental cross-disciplinary training available from a wide variety of departments, programs, research units, and other training activities.
Project start date: 2006-06-01
Project end date: 2011-05-31
5T32MH073517-02 (2007): $159546
1T32MH073517-01A1 (2006): $173156
3/4-RUPP AUTISM NETWORK: GUANFACINE FOR THE TREATMENT OF HYPERACTIVITY IN PDD
James T Mccracken, Professor
University Of California Los Angeles, Office Of Research Administration, Los Angeles, Ca 90095
Grant 1R01MH083747-01A2 from National Institute Of Mental Health
Abstract: This is a multi-site collaborative R01 application from The Research Units on Pediatric Psychopharmacology [RUPP] Autism Network (Indiana University, Seattle Children´s Research Institute, UCLA, and Yale University). Autism is a major public health concern throughout the world. The cost of the disability is estimated to be more than $30 billion annually in the U.S. alone. Recent data indicate that as many as 50% of children with pervasive developmental disorders (PDDs) have moderate to severe problems of hyperactivity and impulsiveness. The impact of these symptoms may be profound and make the child less able to make use of educational and behavioral interventions. Consensus is lacking on how to treat children with PDD accompanied by hyperactivity. Compared to typically developing children with ADHD, children with PDD often show less benefit and greater side effect burden. Guanfacine is commonly used in this population, but poorly studied. Our pilot data indicate that guanfacine is a promising treatment for hyperactivity in children with PDD with a good tolerability profile. In addition, we have identified biomarkers (genetic and neurochemical) that may be associated with positive effects. For these reasons, we chose guanfacine for the proposed rigorous and possibly definitive study in this population. The study involves an 8-week randomized, double-blind, placebo- controlled trial of guanfacine for the 170 children (ages 5-13 years) with PDD accompanied by hyperacti9vity and impulsiveness. Subjects who show a positive response will be invited to enter an 8-week Extension phase (treatment mask will not be broken). The treatment blind will be broken for children who do not achieve a positive response in the Double-blind phase. Children who show no change or deterioration on placebo will be treated with guanfacine in an 8-week Open-label phase. Children who show a partial response to guanfacine will be randomly assigned to a 4-week add on trial of methylphenidate or placebo to evaluate the potential benefits of combined treatment. We expect that 50 subjects will enter this pilot trial. The role of gene variants and urinary adrenergic/noradrenergic measures as biomarkers in moderating response to guanfacine on primary efficacy measures and adverse effects will be explored. This study begins with a randomized trial of guanfacine in 170 children with Pervasive Developmental Disorders accompanied by hyperactivity. Methylphenidate or placebo will be added for children who show partial benefit to guanfacine
Keywords: 0-11 years old; 1, 2-Benzenediol, 4-(1-hydroxy-2-(methylamino)ethyl)-, (R)-; 1, 2-Benzenediol, 4-(2-amino-1-hydroxyethyl)-, (R)-; 2-Piperidineacetic acid, alpha-phenyl-, methyl ester; 4-(1-Hydroxy-2-(methylamino)ethyl)-1, 2-benzenediol; 5-Isobenzofurancarbonitrile, 1-(3-(dimethylamino)propyl)-1-(4-fluorophenyl)-1, 3-dihydro-; ABC20; ABCB1; ABCB1 gene; AD/HD; ADHD; ATP-Binding Cassette, Sub-Family B (MDR/TAP), Member 1 Gene; Acute; Address; Adrenaline; Adrenergic Agents; Adrenergic Drugs; Adrenergics; Adverse Experience; Adverse effects; Adverse event; Affect; Age; Algorithms; Aman; Asperger Syndrome; Asperger`s Disorder; Attention deficit hyperactivity disorder; Attention-Deficit Disorder, Predominantly Hyperactive-Impulsive Type; Autism; Autism, Early Infantile; Autism, Infantile; Autistic Disorder; Behavior; Behavior Conditioning Therapy; Behavior Modification; Behavior Therapy; Behavior Treatment; Behavior or Life Style Modifications; Behavioral Conditioning Therapy; Behavioral Modification; Behavioral Therapy; Behavioral Treatment; Benzeneacetamide, N-(aminoiminomethyl)-2, 6-dichloro-; Blinded; Caring; Catecholamines; Child; Child Youth; Childhood; Children (0-21); Chronic Disease; Chronic Illness; Citalopram; Clinical; Clinical Trials; Clinical Trials, Unspecified; Cognitive; Collaborations; Combined Modality Therapy; Communication; Communities; Conditioning Therapy; Consensus; Cytalopram; Data; Data Banks; Data Bases; Databank, Electronic; Databanks; Database, Electronic; Databases; Deterioration; Development; Diagnosis; Diagnostic; Disease; Disorder; Dose; Double-Blind Method; Double-Blind Study; Double-Blinded; Double-Masked Method; Double-Masked Study; Drugs; Enrollment; Epi; Epinephrine; Excretory function; Family; Funding; GP170; Gene variant; Genetic; Genetic Diversity; Genetic Variation; Genotype; Guanfacine; Health Care Costs; Health Costs; Healthcare Costs; Hexal Brand of Amantadine Sulfate; Human, Child; Hyperactive behavior; Hyperactivity; Hyperactivity Disorder NOS; Hyperactivity Disorder, Predominantly Hyperactive-Impulsive Type; Hyperactivity, Motor; Hyperkinesia; Hyperkinesis; Hyperkinetic Movements; Hyperkinetic Syndrome; Impulsive Behavior; Indiana; Insurance; Intervention; Intervention Strategies; Kanner`s Syndrome; Language; Lead; Levarterenol; Levonorepinephrine; Life Style Modification; MDR-1; MDR1; MDR1 Gene; Masks; Measures; Medical; Medication; Memory, Immediate; Memory, Short-Term; Memory, Shortterm; Mental Health; Mental Hygiene; Methods; Methylphenidate; Monitor; Motion; Motor; Multimodal Therapy; Multimodal Treatment; Multimodality Treatment; Neuro Hexal Brand of Amantadine Sulfate; Neurochemistry; Noradrenaline; Norepinephrine; P-GP; P-Glycoprotein 1 Gene; PBO; PGY1; Parents; Pb element; Persons; Pervasive Development Disorder; Pervasive Developmental Disorder; Pharmaceutic Preparations; Pharmaceutical Preparations; Pharmacological Treatment; Pharmacology-Psychopharmacology; Phase; Pilot Projects; Placebo Effect; Placebos; Population; Prevalence; Productivity; Programs (PT); Programs [Publication Type]; Psychological Health; Psychopharmacology; Psychopharmacology / Toxicology; Public Health; Randomized; Research; Research Institute; Resistance Gene-1, Multidrug; Resistance Gene-1s, Multidrug; Role; Safety; Sampling; Schools; Science of neurochemistry; Services; Severities; Sham Treatment; Short-Term Memory; Site; Social Interaction; Specific qualifier value; Specified; Strategic Planning; Survey Instrument; Surveys; Sympathins; Symptoms; System; System, LOINC Axis 4; Testing; Therapeutic Epinephrine; Treatment Side Effects; United States; Universities; Vaccines; Variant; Variation; Variation (Genetics); adrenergic; allelic variant; attention deficit hyperactive disorder; behavior intervention; behavioral intervention; biomarker; blind; children; chronic disease/disorder; chronic disorder; clinical data repository; clinical data warehouse; clinical investigation; cognitive control; cognitive function; combat; combination therapy; combined modality treatment; combined treatment; cost; data repository; developmental disease/disorder; developmental disorder; disability; disease/disorder; double-blind placebo controlled trial; double-masked controlled study; double-masked controlled trial; drug/agent; early childhood; enroll; evidence base; excretion; expectancy effect; expectation effect; heavy metal Pb; heavy metal lead; impression; improved; interventional strategy; multimodality therapy; neurochemistry; nocebo; noradrenergic; open label; partial response; pediatric; pilot study; pilot trial; placebo response; programs; public health medicine (field); public health priorities; public health relevance; racial and ethnic; racial/ethnic; randomisation; randomization; randomized trial; randomly assigned; relational database; response; sham therapy; side effect; social group; social role; teacher; therapy adverse effect; treatment adverse effect; treatment response; urinary; working memory; youngster
Relevance: This study begins with a randomized trial of guanfacine in 170 children with Pervasive Developmental Disorders accompanied by hyperactivity. Methylphenidate or placebo will be added for children who show partial benefit to guanfacine. Possible effects on cognitive functioning will be examined; potential moderators of treatment responses such as common gene variants and catecholamine excretion will be tested
Project start date: 2010-07-01
Project end date: 2013-03-31
Budget start date: 1-JUL-2010
Budget end date: 31-MAR-2011
PFA/PA: PAR-09-153
1R01MH083747-01A2 (2010): $391103
CIDAR: TRANSLATIONAL RESEARCH TO ENHANCE COGNITIVE CONTROL (TRECC)
James T Mccracken
University Of California Los Angeles, Office Of Research Administration, Los Angeles, Ca 90095
Grant 5P50MH077248-05 from National Institute Of Mental Health
Abstract: This application requests five years of support to establish a multidisciplinary research center at UCLA entitled "Translational Research to Enhance Cognitive Control (TRECC)" as a part of the NIMH Centers for Intervention Development and Applied Research (CIDAR) program. Utilizing our expertise in animal models, cognitive neuroscience, neuroimaging, neuropsychopharmacology, behavioral therapies, genetics, we will advance the science of treatment approaches for the cognitive deficits common to a large number of neuropsychiatric disorders afflicting children and adolescents. We will especially focus on pediatric disorders with prominent problems of cognitive control, particularly the often overlapping disorders of Attention-Deficit/Hyperactivity Disorder (ADHD) and Tourette Syndrome (TS), due to their unmet treatment needs, prevalence, morbidity and comorbidity, and shared pathophysiologic features. Ultimately, we believe our work will be relevant to an even larger group of children with other conditions, but who share the dimension of significant deficits in behavior regulation, cognitive processing, and judgement. The central theme of the UCLA CIDAR TRECC Center is the understanding and modeling of the mechanisms underlying cognitive deficits shared by a range of developmental psychopathologies leading to the development and testing of targeted and more efficacious treatments to enhance cognition in these conditions. Our focus is in direct response to the PA´s call for the development of treatment approaches for clinical targets of illnesses which clearly influence morbidity but which are not sufficiently remediated by extant treatments. Impaired cognition in developmental psychopathologies clearly serves as a major determinant of functioning and long-term outcome. There is a great need to recognize cognitive enhancement in pediatric disorders as a primary treatment target and to develop and test new treatment approaches. If successful, such efforts hold the promise of significantly improving the long-term outcome of individuals with these disabilities. The UCLA CIDAR Center will approach this theme through the completion of four interacting multi-level studies in animals and humans, utilizing the resources developed and made available through three research cores supported by the CIDAR Center
Project start date: 2006-09-01
Project end date: 2011-07-31
Budget start date: 31-AUG-2010
Budget end date: 31-JUL-2011
PFA/PA: PAR-05-039
5P50MH077248-05 (2010): $1630808
5P50MH077248-04 (2009): $1813309
Sponsored Links Excellgen http://Excellgen.com
5P50MH077248-03 (2008): $1823995
5P50MH077248-02 (2007): $1899776
1P50MH077248-01 (2006): $1941375
RESEARCH UNITS ON PEDIATRIC PSYCHOPHARMACOLOGY--AUTISM
James T Mccracken, Joseph Campbell Professor Of Child Psych
University Of California Los Angeles Office Of Research Administration Los Angeles, Ca 90095
Grant 1N01MH070010-00097 from National Institute Of Mental Health
Abstract: The purpose of the contract is to 1) establish qualified clinical research units that, by building of existing research resources at the host Institution and combining the necessary expertise in clinical pharmacology and child psychiatry, can become national resources where studies ont he safety and efficacy of psychotropic medications can be conducted in a prompt and cost effective manner; and 2) fund selected research projects of particular public health significance, in particular in the area of autism and other pervasive developmental disorders, to be conducted at these units. The units, together with the already funded RUPPs will work as a network of research sites and conduct high priority clinical studies in various pediatric ages, conducting research on various aspects of pediatric psychopharmacology, including (but not limited to) dose ranges, dosing regimen, pharmacokinetics, general safety profile, efficacy and effectiveness, and effects on cognition, behavior and development. To establish research units of where clinical studies on the safety, efficacy, pharmacokinetics and pharmacodynamics of psychotropic medications can be investigated in children and adolescents, in general, and in patients suffering from autism and other pervasive developmental disorders in particular. To conduct a minimum of 2 studies at each research unit (of which one shall be a clinical efficacy trial and the other a pharmacokinetic and/or pharmacodynamic dose finding study or a pilot efficacy and tolerability study) during the 3 years of the contract. In addition, if the two year option is exercised, at least another two similar studies (i.e., one efficacy trial and one pharmacokinetic and/or pharmacodynamic dose finding study) shall be conducted. To spur the conduct of other clinical trials and studies in pediatric psychopharmacology to be funded through mechanisms other than this contract (i.e., investigator-initiated grants from federal agencies, private foundations, and pharmaceutical companies).
Keywords: autism, child mental disorder, drug screening /evaluation, human therapy evaluation, mental disorder chemotherapy, pediatric pharmacology, psychopharmacology, adolescence (12-18), child (0-11), clinical trial, dosage, clinical research, human subject
Project start date: 1997-09-30
Project end date: 2000-09-30
Drug Response In Pediatric Psychopharmacology
James T Mccracken, Joseph Campbell Professor Of Child Psych
Psychiatry & Biobehav Sciencesuniversity Of California Los Angeles
office Of Research Administration
los Angeles, Ca 90095
Grant 5K24MH001805-02 from National Institute Of Mental Health IRG: ZRG1
Abstract: The proposed Mid-Career Investigator Award in Patient-Oriented Research (K24) includes a program of career development training, research in pediatric psychopharmacology, and research mentoring of young investigators. A major focus of the project is to acquire additional research skills with which to better identify possible predictors of therapeutic drug response and adverse reactions to psychotropics used in the treatment of childhood neuropsychiatric illnesses. The research project proposes additional analyses of potential predictor variables from the candidate´s involvement in the multi-site NIMH Research Units on Pediatric Psychopharmacology (RUPP) Autism Risperidone Study. Predictor variables relating to the serotonin system and drug metabolism will be explored, with the goal of generating hypotheses to be replicated in other samples. The candidate is a mid-level faculty member with a track record of researching the neurobiology of neuropsychiatric disorders in children and adolescents, who has evolved to have an increasing focus on pediatric psychopharmacology. The additional career training plan includes courses in biostatistics, genetics, and neuropharmacology. The didactic coursework is augmented by extramural coursework, laboratory training, and tutoring with faculty in the UCLA School of Medicine. The proposed training experience dovetails with the candidate´s ongoing research involvement enabling an integration of training goals with research application. The candidate proposes to continue and expand ongoing mentoring activities of research trainees and junior faculty. The support from the proposed Mid-Career Award would significantly enhance the candidate´s research background and enable a redoubled effort in his research and mentoring activities
Keywords: autism, pediatrics, psychopharmacology drug adverse effect, drug metabolism, human therapy evaluation, risperidone, serotonin, training adolescence (12-20), child (0-11), human subject, patient oriented research
Project start date: 2001-08-14
Project end date: 2006-06-30
5K24MH001805-02 (2002): $132328
1K24MH001805-01A2 (2001): $132189
5K24MH001805-05 (2005): $132328
5K24MH001805-04 (2004): $132328
5K24MH001805-03 (2003): $132328
OCD COLLABORATIVE GENETICS ASSOCIATION STUDY
James T Mccracken, Professor
University Of California Los Angeles, Office Of Research Administration, Los Angeles, Ca 90095
Grant 5R01MH079487-04 from National Institute Of Mental Health
Abstract: The OCD Collaborative Genetics Group proposes to conduct a genome-wide association study of early-onset obsessive-compulsive disorder (OCD). This group of six academic centers has collaborated over the past five years on an on-going genetic linkage study of OCD and has demonstrated ability to recruit and diagnose individuals with this disorder. In this proposal, the Collaboration will conduct psychiatric evaluations on 2,000 individuals with obsessive-compulsive disorder (OCD) and collect DNA from these individuals and both their parents. The genotyping and analyses will be performed in two stages. In the first stage 1,000 triads will be genotyped with a 550,000 single nucleotide polymorphisms (SNPs) panel at the Illumina laboratory. We will estimate the genetic effect sizes for all 550,000 SNPs, and then rank all SNPs based on their conditional power estimates. The 1,534 SNPs with the highest power rankings will be genotyped in the second stage (1,000 triads). The combined p-values from the two stages (which will have to be adjusted for only 1,534 comparisons, but not for 550,000) that are less than 5%/1534 (Bonferroni correction) will be considered genome-wide significant. The indirect association approach proposed will be followed up using more direct association techniques (gene based), innovative gene-gene interaction analyses (gene cluster based), and additional molecular and functional approaches. The results of these analyses will guide future molecular strategies to identify genes involved in the pathogenesis of OCD. The clinical and genotype data from the sample will be publicly available for OCD genetics research
Keywords: Active Follow-up; Alleles; Allelomorphs; Arts; Biocompatible Materials; Biomaterials; Chronic; Clinical; Collaborations; DNA; DSM; Data; Deoxyribonucleic Acid; Diagnosis; Diagnostic and Statistical Manual; Disease; Disorder; Dose; Dysfunction; Evaluation; Family; Functional disorder; Future; GWAS; Gene Cluster; Genes; Genetic; Genetic Models; Genetic Predisposition; Genetic Predisposition to Disease; Genetic Research; Genetic Susceptibility; Genotype; Individual; Inherited Predisposition; Inherited Susceptibility; Laboratories; Linkage (Genetics); Methods and Techniques; Methods, Other; Molecular; Obsessive-Compulsive Disorder; Obsessive-Compulsive Neurosis; Parents; Participant; Pathogenesis; Physiopathology; Polymorphism, Single Base; Productivity; Recruitment Activity; Reporting; Risk; SNP; SNPs; Sampling; Single Nucleotide Polymorphism; Site; Staging; Streptococcal Infections; Streptococcus infection; Techniques; Testing; Triad; Triad Acrylic Resin; Triad resin; association test; base; disease/disorder; early onset; follow-up; gene discovery; gene interaction; genetic association; genetic etiology; genetic linkage; genetic mechanism of disease; genetic vulnerability; genome wide association scan; genome wide association studies; genome wide association study; genome-wide; genome-wide scan; genomewide association scan; genomewide association studies; genomewide association study; genomewide scan; innovate; innovation; innovative; pathophysiology; recruit; response; whole genome association studies; whole genome association study
Project start date: 2007-09-27
Project end date: 2011-07-31
Budget start date: 1-AUG-2010
Budget end date: 31-JUL-2011
PFA/PA: PA-07-092
5R01MH079487-04 (2010): $69300
Sponsored Links Excellgen http://Excellgen.com
5R01MH079487-03 (2009): $242550
5R01MH079487-02 (2008): $242550
1R01MH079487-01A1 (2007): $242550
METHYLPHENIDATE EFFICACY AND SAFETY IN ADHD PRESCHOOLERS
James T Mccracken, Joseph Campbell Professor Of Child Psych
University Of California Los Angeles Office Of Research Administration Los Angeles, Ca 90095
Grant 5U01MH060900-03 from National Institute Of Mental Health IRG: ZMH1
Abstract: Adapted from Applicant s ) This six-site parallel R01 application requests funding for a three year study of the efficacy and safety of methylphenidate (MPH) in preschool children with Attention-Deficit/ Hyperactivity Disorder (ADHD). Although MPH s use in all age groups is increasing, its package insert prohibits its use in preschool children. Previous MPH preschool treatment studies have few subjects, and their results cannot be combined to yield needed safety information. The proposed study will address these concerns by mounting a six-site, controlled trial of 44 ADHD children per site, or 264 children total. It will be based at the New York State Psychiatric Institute (NYSPI), Duke University, Johns Hopkins University (JHU), New York University (NYU), University of California at Los Angeles (UCLA), and University of California at Irvine (UCI). Each site s subjects (N=44) will include Group 1, ADHD preschoolers (n=33), ages 3-5 years, 6 months; and Group 2 (n=11), a contrast ADHD group, ages 6-8. After assessment, all children will enter a four-part study. Phase l will be a 3 week, open-label safety titration trial of MPH, 2.5 - 10 mg/dose, given 3 times daily (t.i.d.). Those without impairing side effects will enter Phase 2, a five week double-blind, placebo controlled, titration trial, with random assignments (weekly) to either placebo or to one of 4 doses of MPH (2.5, 5, 7.5, and 10 mg/dose) and monitored once in a laboratory (analog) classroom. Phase III will be an open-label, one-year extension, and Phase IV will be a double-blind, placebo discontinuation trial. Aim I is to determine the safety and efficacy of MPH in preschoolers with ADHD. Aim 2 is to test for differences between Groups 1 and 2 in dose-response to MPH. Aim 3 is to examine if two putative risk loci, the dopamine D4 receptor gene (DRD4) or the dopamine transporter gene (DATI), are associated with ADHD in a family-based association study of parent to child allele transmission, and whether dose response to MPH is related to generic variability at these two loci.
Keywords: attention deficit disorder, drug screening /evaluation, human therapy evaluation, mental disorder chemotherapy, methylphenidate, preschool child (1-5), behavioral genetics, clinical trial phase I, clinical trial phase III, cooperative study, dopamine receptor, dopamine transporter, family genetics, middle childhood (6-11), pharmacogenetics, behavioral /social science research tag, clinical research, human subject
Project start date: 2000-09-22
Project end date: 2004-09-14
5U01MH060900-03 (2003): $232514
5U01MH060900-02 (2001): $492849
1U01MH060900-01A1 (2000): $456840
SLEEP AND HORMONE REGULATION IN JUVENILE DEPRESSION
James T Mccracken, Joseph Campbell Professor Of Child Psych
Los Angeles County Harbor-ucla Med Ctr Harbor-ucla Medical Center Torrance, Ca 90509
Grant 5M01RR000425-210412 from National Center For Research Resources
Keywords: CHILDREN, ENDOCRINOLOGY, HORMONAL REGULATION AND CONTROL (MECHANISMS), PSYCHIC ACTIVITY LEVEL, SLEEP, PSYCHOLOGY, EMOTIONS, DEPRESSION, ADRENAL CORTEX HORMONES ANALOGS, DEXAMETHASONE, PITUITARY-DIENCEPHALON HORMONES, THYROTROPIN RELEASING FACTORS, TROPANES, SCOPOLAMINE, HUMAN, CLINICAL