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

A -- TREATMENT FOR BIPOLAR DISORDER SOL NIMH-98-DS-0001 DUE 060198 POC Contracting Officer, David Eskenazi or Patricia Gibbons, (301) 443-2696 The National Institute of Mental Health proposes to issue a solicitation (RFP) No. NIMH-98-DS-0001 entitled "Treatment for Bipolar Disorder" 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 September 30, 1998. This will be the initial award for this requirement. The purpose of this contract is to launch a major public study that will provide data to optimize treatment of bipolar disorder in adults and older persons. It is anticipated that one award will be made to a single coordinating center to plan and administer the initiative. The study will assess the long-term impact of different treatments, either individually or in combination, on a broad range of clinical and functional outcomes in a diagnostically and demographically heterogeneous population. Data from this study are expected to inform treatment practice in community populations. The primary study should focus on understanding what interventions (pharmacologic and psychosocial) provide the best outcomes (both clinical and functional) for different types of people and various stages of the disorder. In addition, it should address the impact of other factors on the delivery of and compliance with treatment interventions. Data from the study should be able to inform the provision of care in broad categories of people with bipolar disorder in the community. Ancillary studies may contribute to the primary focus but they could also consider additional research issues in bipolar disorder. Through the primary intervention trial or through ancillary studies, the focus should be on patients that are severely impacted by the illness and who are often excluded from traditional research trials due to their complicating diagnostic comorbidities and the need for multiple medications. It should give consideration to patients who are unstable, who have rapid cycling or mixed states. It should include patients with complicating diagnostic comorbidities (substanceabuse, other mental disorders, other physical or neurological illnesses), the need for multiple medications, and a wide variety of demographic characteristics (age, sex, race or ethnicity, residential setting). It should consider patients who experience breakthrough depression and if or how antidepressants should be used as adjuncts. It should determine if, when, and how to add an antipsychotic medication and for how long to continue it in patients with hypomania. There should be systematic evaluation of complex combination therapies, both for their potential therapeutic advantage as well as any adverse effect advantage. If the first treatment fails, what is the next best treatment? How are refractory patients best treated? What are the risks for discontinuation syndromes, and how can they be avoided? When a new medication is made available, where does it best fit in a stepwise medication algorithm and for whom? This initiative is based on a public health model of intervention research. The overall objective of this initiative is to develop a research-validated multimodal approach to the acute treatment and long-term management of bipolar disorder in a representative sample of patients selected from a broad range of health care settings. This treatment approach is expected to target recovery from the illness and the optimization of function, not simply stabilization of acute symptoms. Request for Proposal (RFP) No. NIMH-98-DS-0001 will be available on or about March 31, 1998 and the receipt date of proposal on or about June 1, 1998. 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", then select "NIMH Request for Proposals (RFP)", and lastly select "NIMH-98-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 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. (0072)

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