Pediatric Psychopharmacology National Institute of Mental Health.

Pediatric Psychopharmacology

National Institute of Mental Health

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

Primary Research Questions

1. What is the efficacy/effectiveness and safety of the most commonly used treatment and preventive interventions?

2. How current interventions can be improved?

3. How novel interventions can be developed?

Primary Research Questions4. What is the long-term impact of

treatments?5. How to address treatment non-

response?6. Which interventions for which

patients?7. What is the impact of comorbidity?8. How do interventions work?

Child and Adolescent Treatment and Preventive Intervention Research Branch

CT - FY99 Funding Total: $40.5 millions

45%55%

Prevention

Treatment

Child and Adolescent Treatment and Preventive Intervention Research Branch

FY 99 Funds Treatment Research

($ 22.3 millions)

Combined Tx42%

Psychosocial Tx32%

Psychopharm26%

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

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

Research

Units

Pediatric

Psychopharmacology

Network

Research Units on Pediatric

Psychopharmacology 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

Research Units on Pediatric

Psychopharmacology Research Units on Pediatric

Psychopharmacology

Columbia University L. Greenhill, M.D. Johns Hopkins University M. Riddle, M.D. Pittsburgh University B. Birmaher, M.D.

Yale University F. Volkmar, M.D. UCLA J. McCracken, M.D. Indiana University C. McDougle, M.D. Ohio State University M. Aman, Ph.D.

Research Units on Pediatric PsychopharmacologyResearch 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)

Research Units on Pediatric

Psychopharmacology 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

 Research Units on Pediatric

Psychopharmacology

 Research Units on Pediatric

Psychopharmacology

Some Multisite Protocols: 

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

TADSTreatment for Treatment for

Adolescents with Adolescents with Depression StudyDepression Study

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.

TADS N=432 Age: 12-17 years Dx: major depression Design: parallel-group Tx: Med, CBT, CBT+Med, Placebo Sites: 10

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

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

Preschool ADHD Treatment Study

Age 3-5 yrs (N=198) vs. Age 6-8 yrs (N=66)

Screening/evaluation 8 weeksOpen titration 3 weeksPlacebo-controlled trial 12 weeksOpen maintenance 10 monthsBlinded discontinuation 6 weeks

Some areas in need of expansion

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