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

A -- NEW ANTIPSYCHOTIC DRUG TRIALS SOL NIMH-99-DS-0001 DUE 012599 POC David Eskenazi or Patricia Gibbons, Contracting Officer (301) 443-2696 WEB: NIMH Home Page, http://www.nimh.nih.gov. E-MAIL: Click here to reach contracting officer via email, de5d@nih.gov. The National Institute of Mental Health proposes to issue a solicitation (RFP) No. NIMH-99-DS-0001 entitled "New Antipsychotic Drug Trials" as Full and Open Competition under SIC Code 8093. The NIMH plans to award a five year cost-reimbursement contract, and plans to make the award by June 15, 1999. This will be the initial award for this requirement. The purpose of this contract is to study the comparative efficacy and effectiveness of the new atypical antispychotics through a series of clinical trials in patients with schizophrenia, patients with psychotic depression, and patients with Alzheimer's disease. These trials will be based on a public health model of interventions research, with a focus on effectiveness and outcome, rather than efficacy alone. Psychotic symptomatology will be examined, but so will broader outcomes, including compliance, residual disability, recovery from illness, and long term vocational and social function. A major objective is generalizability, and the trials will be as inclusive as possible. Patients will be carefully diagnosed, characterized, and stratified within trials, but comorbid psychiatric or medical disorders will not be excluded (except for safety reasons). A premium will be placed on demographic (age, sex, and race) and geographic (urban and rural) diversity. Multiple treatment and residential settings will be studied. These trials will be useful only if their findings affect actual clinical practice. Only FDA approved, marketed antipsychotics will be studied, but there will be a mechanism for adding new drugs to the trial as they are released. The trials will provide data on the optimum choice of antipsychotic in different subgroups, appropriate dose range, and any unique safety issues within each group. The primary independent variable will be the new drugs, but interactive effects with psychosocial intervention and treatment setting will be examined as well. The specific aims and hypotheses tested in a trial will differ based on the diagnostic group studied. However, NIMH recognizes that the breadth of objectives and desire for generalizability mean that these trials will to a certain degree be descriptive and will generate hypotheses to be tested in future studies. One of the anticipated results of the present initiative is the development of a network of sites and investigators able to respond to future needs for outcome focused treatment research. Request for Proposal (RFP) No. NIMH-99-DS-0001 will be available on or about November 2, 1998 and the receipt date of proposal on or about January 25, 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, first select "Grants and Contracts", select "NIMH Request for Proposals (RFP)", and lastly select "NIMH-99-DS-0001." 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 informationrequired 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 10/16/98 (W-SN262892). (0289)

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