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

A -- TREATMENT RESISTANT DEPRESSION SOL NIMH-99-DS-0003 DUE 030299 POC David Eskenazi or Patricia Gibbons, Contracting Officer (301) 443-2696 E-MAIL: Click here to reach contracting officer via email, pgibbons@mail.nih.gov. The National Institute of Mental Health (NIMH) proposes to issue a Request for Proposal (RFP) No. NIMH-99-DS-0003 entitled "Treatment Resistant Depression (TRD)" under Full and Open Competition procedures using Standard Industry Code 8093. In recognition of the great public health significance of the problem of TRD, NIMH plans to undertake a large-scale clinical trial investigating treatment approaches to TRD. A five (5) year base contract with an option for an additional three (3) years is contemplated. This contract would fund a major public health oriented intervention study of treatment approaches for management of TRD in adults and older persons. The contractor/coordinating center will plan and administer a trial assessing the acute and long-term impact of different treatment algorithms employing broad clinical and functional outcomes in a diagnostically and demographically heterogeneous population. Underlying this initiative is the dilemma that confronts the field concerning the practical limitations of designing a trial of treatment approaches to TRD. A large number of treatment options are currently in use as secondary therapy including numerous augmentation and drug switching strategies. Comparisons of these treatment modalities having adequate statistical power would require large numbers of patients. This problem is compounded by the fact that using stringent criteria for the definition of treatment resistance, patient recruitment is a limiting factor. Selecting the key questions to be addressed and designing a trial with sufficient external validity and statistical power will necessitate a major collaborative effort. NIMH anticipates that there will be a primary study which will focus on understanding what interventions (pharmacologic and psychosocial) provide the best outcomes (both clinical and functional) for patients who fail to respond to initial treatment of depression. Additionally, it would address the impact of other factors on the delivery of and compliance with treatment interventions. NIMH envisions that data from the study should be able to inform the provision of care in broad categories of people with TRD in the community. Ancillary studies would contribute to the primary focus but could also consider additional research issues in TRD. Request for Proposal (RFP) No. NIMH-99-DS-0003 will be available on or about December 2, 1998 and the receipt date of proposal on or about March 2, 1999. The RFP may be accessed through the NIMH Home Page by using the following instructions: access the home page at, http://www.nimh.nih.gov/grants/indexcon.htm then select "NIMH Request for Proposals (RFP)", and lastly select "NIMH-99-DS-0003." Please note that the RFP for this requirement will include the Statement of Work, Deliverables and Reporting Requirements, the Technical Evaluation Criteria, and proposal preparation instructions. All information required for the submission of an offer will be contained in the electronic RFP package. Following proposal submission and initial review process, offerors comprising of the competitive range will be requested to provide additional documentation to the Contracting Officer. All responsible sources may submit a proposal that will be considered by the NIMH. This advertisement does not commit the Government to award a contract. Posted 11/17/98 (W-SN272196). (0321)

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