Pediatric Psychopharmacology

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Pediatric Psychopharmacology

• National Institute of Mental Health

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Child and Adolescent Treatment and Preventive
Intervention Research Branch

• Mission
• To promote, conduct, and coordinate federally
  funded research on the effects of treatment and
  prevention of mental illness in children and
  adolescents

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Primary Research Questions

• What is the efficacy/effectiveness and safety of
  the most commonly used treatment and preventive
  interventions?
• How current interventions can be improved?
• How novel interventions can be developed?

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Primary Research Questions

• What is the long-term impact of treatments?
• How to address treatment non-response?
• Which interventions for which patients?
• What is the impact of comorbidity?
• How do interventions work?

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Child and Adolescent Treatment and Preventive
Intervention Research Branch
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Child and Adolescent Treatment and Preventive
Intervention Research Branch
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Child and Adolescent Treatment and Preventive
Intervention Research Branch

• Research funding in 1999 (millions)
• Prevention 18.2
• Psychosocial Tx 7.1
• Psychopharm. 5.9
• Combined Tx 9.3

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Child and Adolescent Treatment and Preventive
Intervention Research Branch

• Major areas of funding by disorder
• (1999, in millions)
• Depression 8.0
• Anxiety 2.6
• ADHD 2.5
• Autism 2.2

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• Research
• Units
• Pediatric
• Psychopharmacology
• Network

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Research Units on Pediatric Psychopharmacology

• Network of research units devoted to multi-site
  clinical trials in children
•  
• Units are at academic research settings
•  
• Main focus is on efficacy and safety of
  psychotropic medications that are commonly used
  in children without adequate data
•  
• Established in 1996-1997 through competitive
  contracts

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Research Units on Pediatric Psychopharmacology

• Columbia University L. Greenhill, M.D.
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• Johns Hopkins University M. Riddle, M.D.
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• Pittsburgh University B. Birmaher, M.D.
• Yale University F. Volkmar, M.D.
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• UCLA J. McCracken, M.D.
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• Indiana University C. McDougle, M.D.
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• Ohio State University M. Aman, Ph.D.

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Research Units on Pediatric Psychopharmacology

• Each RUPP has experts in child psychiatry,
  psychopharmacology, pediatrics, clinical trial
  design and methods
•  
• Data management center
•  
• Network statistician
•  
• The network as a resource available to potential
  sponsors of clinical trials in children (e.g.,
  NIH, industry, private foundations)

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Research Units on Pediatric Psychopharmacology

• NIMH supports
•  
• Basic infrastructure for the units
•  
• Data management center
•  
• Specific protocols in areas that are
•  
• Of public health importance
•  
• Not funded, or unlikely to be
• funded through grant mechanisms
•  
• Not sponsored by industry

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  Research Units on Pediatric Psychopharmacology

• Some Multisite Protocols
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• SSRI for Children with Anxiety Disorders
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• Risperidone for Children with Autism and
• Behavioral Disturbances
•  
• SSRI for Depressed Children with Bipolar
• Disorder
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• Sequential Treatments for Children with
• Comorbid ADHD and Anxiety Disorders

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TADS
Treatment for Adolescents with Depression Study
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Primary Aims

• To compare the effectiveness of FLX, CBT, COMB,
  and PBO for reducing MDD symptoms and patient
  disability acutely.
• To compare the effectiveness of the three active
  treatments (FLX, CBT, and COMB) during long-term
  treatment.
• To compare the speed of response of FLX, CBT and
  COMB.

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TADS

• N432
• Age 12-17 years
• Dx major depression
• Design parallel-group
• Tx Med, CBT, CBTMed, Placebo
• Sites 10

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Stages of Treatment Model

• Stage I Acute treatment for 12 weeks
• Stage II Consolidation for 6 weeks
• Stage III Maintenance for 18 weeks
• Stage IV One year open follow-up

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Recently Funded Grants

• Relapse prevention in youths with depression
• Treatment of SSRI-resistant depression in
  adolescents
• Mood stabilizers for youths with bipolar
• Efficacy and safety of methylphenidate in
  preschoolers with ADHD

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Preschool ADHD Treatment Study

• Age 3-5 yrs (N198) vs. Age 6-8 yrs (N66)
• Screening/evaluation 8 weeks
• Open titration 3 weeks
• Placebo-controlled trial 12 weeks
• Open maintenance 10 months
• Blinded discontinuation 6 weeks

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Some areas in need of expansion

• Schizophrenia and other psychoses
• Bipolar
• Depression in prepubertal children
• Autism
• Comorbid conditions