# Presentation: 902501

## 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

- 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?

## 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?

## 		Child and Adolescent 	Treatment and Preventive Intervention    		    Research Branch

## 		Child and Adolescent 	Treatment and Preventive Intervention    		    	Research Branch

## 		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 

**U****nits**
**P****ediatric**
**P****sychopharmacology**
**	****	****Network**** **

## 	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 

**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 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 

**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

**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**

## TADS

- <date/time>

- TADS

**Treatment for Adolescents with  Depression Study**

## 		Primary Aims  

- <date/time>

- 		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 weeks
- Open titration			3 weeks
- Placebo-controlled trial		12 weeks
- Open maintenance 		10 months
- Blinded discontinuation		6 weeks

## Some areas in need of expansion

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