National Institute of Mental Health, Contracts Management Branch, 5600 Fishers Lane, Rm. 9C-15, Rockville, MD, 20857-8030

A -- EFFECTIVENESS OF TREATMENT FOR ADOLESCENTS WITH MAJOR DEPRESSION DUE 032598 POC Contracting Officer, David Eskenazi or Patricia Gibbons 301/443-2696 A clinical trial will be launched, with adequate statistical power to address a number of research questions related to the Treatment of Depression in Adolescents. In order to acquire the necessary sample size (estimated to be in the order of 350-500 adolescents) and ensure adequate representation of adolescents, it is estimated that 5 to 10 sites will be needed. The actual proposed sample size must be adequately supported and convincingly justified by a complete power analysis calculation. This project will involve a multi-center effort and a collaborative relationship between the coordinating center, clinical site investigators, and NIMH staff. The main organizational components will be: 1) the Coordinating Center; 2) the study Steering Committee, formed by the Principal Investigators of the clinical sites, the Contractor (Coordinating Center), the GPO, and other NIMH representatives, as designated by the GPO; 3) the study Scientific Advisory Group, consisting of independent advisors to provide consultation on the scientific aspects of the study; 4) the Publication Committee charged to coordinate the preparation of publishable reports; and 5) the NIMH Data Safety and Monitoring Board (or DSMB), consisting of independent experts in clinical trials and charged with reviewing the safety and progress of the study. The contractor shall have sufficient expertise in research on the treatment of major depression in adolescents to recruit sites and coordinate activities designed to answer the following major questions: a) How effective is long-term (i.e., at least 6 months) pharmacological treatment of adolescents with major depression? What is the impact of treatment on symptom reduction, disorder remission, and level of functioning in school, at home, or in the community, and on the use of auxiliary services? b) How effective is long-term cognitive-behavioral therapy in the treatment of major depression in adolescents with major depression? What is the impact of the treatment on symptom reduction, disorder remission, and level of functioning in school, at home, or in the community, and on the use of auxiliary services? c) How do these pharmacological and psychotherapeutic treatments compare with each other in terms of effectiveness, tolerability, and adolescent and family acceptance? d) Will adolescents who are not responsive to one treatment approach (either pharmacotherapy or psychotherapy) respond to the other treatment approach? In order to organize and coordinate these activities, interested organizations should have staff expertise in the following areas: a research child and adolescent psychiatrist with pharmacological expertise, a research psychologist with expertise in cognitive-behavioral therapy for adolescents with depression, a statistician with primary expertise in clinical trial design and analysis, and experts for each of the following areas: the design of clinical trials, protocol preparation, the development of a treatment manual, the monitoring of data quality, and the design of clinical research forms. The expertise of these key staff should not be limited to the clinical aspects of these activities, but extend to in-depth knowledge of experimental research. (0065)

Loren Data Corp. http://www.ld.com (SYN# 0015 19980310\A-0015.SOL)