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 Questions 4. 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

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

l R esearch l U nits l P ediatric l P sychopharmacology Network

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

Research Units on Pediatric Psychopharmacology Columbia UniversityL. Greenhill, M.D. Johns Hopkins UniversityM. Riddle, M.D. Pittsburgh UniversityB. Birmaher, M.D. Yale UniversityF. Volkmar, M.D. UCLAJ. McCracken, M.D. Indiana UniversityC. McDougle, M.D. Ohio State UniversityM. Aman, Ph.D.

Research Units on Pediatric Psychopharmacology l Each RUPP has experts in child psychiatry, psychopharmacology, pediatrics, clinical trial design and methods l Data management center l Network statistician l 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 NIMH supports: l Basic infrastructure for the units l Data management center l Specific protocols in areas that are: 4 Of public health importance 4 Not funded, or unlikely to be funded through grant mechanisms 4 Not sponsored by industry

Research Units on Pediatric Psychopharmacology Some Multisite Protocols: l SSRI for Children with Anxiety Disorders l Risperidone for Children with Autism and Behavioral Disturbances l SSRI for Depressed Children with Bipolar Disorder l Sequential Treatments for Children with Comorbid ADHD and Anxiety Disorders

TADSTADS Treatment for Adolescents with Depression 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: 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/evaluation8 weeks Open titration3 weeks Placebo-controlled trial12 weeks Open maintenance 10 months Blinded discontinuation6 weeks

Some areas in need of expansion Schizophrenia and other psychoses Bipolar Depression in prepubertal children Autism Comorbid conditions