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A -- COORDINATING CENTER FOR CLINICAL TRIAL OF HYPERICUM PERFORATUM IN DEPRESSIVE DISORDER SOL NIMH-97-CR-0007 DUE 072197 POC Patricia L. Gibbons, Contracting Officer Ph. (301)443-2696 Fax (301)443-0143 A -- COORDINATING CENTER FOR CLINICAL TRIAL OF HYPERICUM PERFORATUM IN DEPRESSIVE DISORDER. SOL NIMH-97-CR-0007. DUE 072197. POC Patricia L. Gibbons, (301)443-2696. The Psychotherapeutic Medication Development Program of the National Institute of Mental Health (NIMH) is committed to developing "orphan" treatments (treatments having a potentially large public health impact but lacking corporate sponsorship) for mental disorders. For about 15 years, Europeans have used an herbal treatment for depres sion, Hypericum perforatum/Saint Johnswort (hypericum). Hypericum has become increasingly popular in Germany where physicians routinely prescribe herbal medicines. In 1994, 66 million daily doses of hypericum were prescribed there for use in the treatment of depression. Working with the NIH Office of Alternative and Complementary Medicine (OAM), NIMH intends to conduct a efficacy study of a standardized extract of hypericum in major depression. The purpose of this requirement is to establish a full serv ice centralized coordinating center to manage a multi-center clinical trial to evaluate the efficacy of this botanical (hypericum) in patients with depression. The offeror will be responsible for recruiting sites from a range of diverse environments including clinical, university and research settings. Unlike many other clinical trials, most patients eligible for this study will not be treated in a university clinic but rather in private practice offices or in managed care settings. The contractor must have established working relationships and a consortium of mental health care providers readily available. The use of hypericum has generated a substantial amoun t of recent interest in the media, which makes it imperative that sites are identified which can begin recruiting patients within a limited period after award. The successful offeror shall: 1) have available staff resources to provide the medical expertise necessary for medical monitoring and oversight of the trial; 2) finalize the study design and protocol; 3) monitor patient recruitment and site compliance with the study protocol; 4) provide standardized data forms and perform all necessary data management activities (scheduling, monitoring, collecting, editing data from each of the clinical sites, etc.); 5) ensure patient safety; 6) maintain standardization acr oss sites; 7) prepare and analyze the composite data set; and 8) perform all other activities necessary to coordinate trial activities. NIMH proposes to issue an unrestrictive competitive solicitation for this requirement and anticipates the award of a cost reimbursement contract for a period of three years. Request for Proposal (RFP) will be available electronically on or about June 5, 1997 with proposals due on or about July 21, 1997 and anticipates the award of a cost reimbursement contract for a period of three years. Request for Proposal (RFP) No. NIMH-97-CR-0007 will be available electronically on or about June 5, 1997, with proposals due on or about July 21, 1997. The RFP may be accessed through either the NIH Home Page, the NIH Gopher or the NIMH Home Page by using the following electronic addresses and instructions: 1. NIH Home Page (via the World Wide Web): Access the NIH Home Page by using http://www.nih.gov. Once you are at the NIH Home Page, select "Grants and Contracts," then select "NIH Gopher directory," item listed under the "Contracts Page" Section. The Uniform Resource Locator (URL) for this gopher director is gopher://gopher.nih.gov:70/11/res/rd-rfp. 2. To access the NIH Gopher: Point your gopher client to GOPHER.NIH.GOV (you should now be in the NIH Gopher). Select "Grants and Research Information," then select "R&D Requests for Proposals (RFP)." 3. NIMH Home Page: Access the NIMH Home page by using http://www.nimh.nih.gov. Once you are there, select "Grants, Contracts & Committees," item listed under "NIMH Request for Proposals (RFP)." Please note that the RFP for this procurement has been revised to include only the Statement of Work, Deliverable 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 the initial review process, offerors comprising 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. Point of Contact: Patricia Gibbons, Contracting Officer, Contract Management Branch, National Institute of Mental Health, National Institutes of Health, 5600 Fishers Ln., Rm. 9C-15, Rockville, MD 20857-8030. Electronic mail address: pgibbons@nih.gov, Telephone: (301)443-2696, FAX: (301) 443-0143. No collect calls will be accepted. (0133). (0139)

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