National Institute of Mental Health, Contracts Management Branch, Room 9C-15, Parklawn Building, 5600 Fishers Lane, Rockville, Maryland 20857

A -- PILOT STUDY OF A CALCIUM CHANNEL BLOCKER IN FEMALES WITH BIPOLAR DISORDER SOL NIMH-96-CR-0006 POC Contracting Officer, Patricia L. Gibbons, 301/443-2696 The proposed requirement is issued under Full & Open Competitive Procedures, the SIC code is 8093 and the size standard is 3.5 million dollars. The purpose of this requirement, ''Pilot Study of a Calcium Channel Blocker in Females with Bipolar Disorder,'' is to develop and initiate a clinical efficacy study of a calcium channel blocker such as verapamil in females with bipolar disorder for an alternative treatment of bipolar disorder that is significantly less toxic than the current medications. research activities will be conducted by clinical investigators skilled in the treatment of bipolar disorder, who successful compete for participation in the multi-center study, using a common protocol. The objectives of this requirement are as follows: 1. To determine in the most cost effective manner, preliminary evidence of efficacy for verapamil in bipolar disorder, and 2. Recruit appropriate patients for the trial and enroll, randomize and initiate medication treatment for approximately ten (10) patients per year for two and one-half (2.5) years. The successful offeror will need to exhibit the availability of staff, facilities, and institutional support necessary to conduct clinical trials on females, using FDA approved medications. The offeror will also have to evidence that he/she has a current and ready supply of female bipolar patients whose case histories are know to them and will be able to conduct clinical investigation in a prompt and cost-effective manner. A base two and one-half (2.5) year period of performance and one, two (2) year option cost reimbusement completion type contract is anticipated (this is a new requirement) RFP #NIMH-96-CR-0006 is scheduled for issuance on or about 15 days after publication of this notice and will close approximately 55 calendar days thereafter. All requests must be made in writing or by FAX (301)443-0143. Telephone requests will not be honored. (0150)

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