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

A -- TREATMENT RESISTANT DEPRESSION SOL NIMH-98-RFI-02 DUE 091698 POC Patricia L. Gibbons, Contracting Officer (301) 443-2696 WEB: NIMH Home Page, http://www.nimh.nih.gov. E-MAIL: Click here to contact the contracting officer via, pgibbons@mail.nih.gov. REQUEST FOR INFORMATION -- NIMH-98-RFI-02 "TREATMENT RESISTANT DEPRESSION" This Request For Information (RFI)/Sources Sought Notice (SS) is for information and planning purposes only and shall not be construed as a solicitation or as an obligation on the part of the National Institute of Mental Health (NIMH). The purpose of this RFI/SS is to identify potential sources that may be interested in and capable of performing the work described herein. NIMH welcomes comments from all individuals on each or all of these questions. The NIMH does not intend to award a contract on the basis of responses nor otherwise pay for the preparation of any information submitted or NIMH's use of such information. Acknowledgment of receipt of responses will not be made, nor will respondents be notified of the NIMH's evaluation of the information received. As a result of this RFI/SS, the NIMH may issue a Request for Proposals (RFP). In the event a RFP will be issued, Standard Industrial Classification (SIC) code 8093 will apply. However, should such a requirement materialize, no basis for claims against the NIMH shall arise as a result of a response to this RFI or the NIMH's use of such information as either part of our evaluation process or in developing specifications for any subsequent requirement. Request for Information: The NIMH seeks input and comment on its plans to study intervention approaches to treatment resistant depression in adults and older persons. NIMH intends to award a single contract with multiple scientific and administrative components to conduct trials components to conduct trials of intervention strategies for the treatment of patients who have less than optimal responses to initial treatment of their depression. A public health model of effectiveness research is the central feature of the approach taken in this initiative. NIMH envisions an intervention model that addresses the goals of this initiative and will include a process for revising and refining the model. The NIMH anticipates two major phases: protocol development and clinical trial coordination and administration. A third phase may consist of ancillary or extension studies that are contingent upon results obtained from the earlier phases. Therefore, the proposal for the two major phases will focus primarily on scientific aims and methodological approaches. Preliminary protocols should be presented with the understanding that a period of refinement will be incorporated for the finalization of the protocols. NIMH strongly encourages collaborative efforts and collegial interactions among potential offerors. It should be noted that an offeror may participate in multiple proposals as subcontractor or investigator. However, an offered may be overall PI or primary contractor on only one proposal. The overriding concern is the technical merit and scientific quality of the individual trials and NIMH reserves the right to expand or restrict the scope of the proposed studies during the protocol finalization process. To aid in the design of a possible future solicitation, the NIMH asks for comments on the following issues: 1) Prioritization of Research Questions and Treatment Options to be Considered. A vast number of treatment options exist for the management of treatment resistant depression ranging from psychotherapeutic to pharmacologic interventions. NIMH would like to obtain information from the field to guide the prioritization of the treatment options to be studied. Options to be considered include innovative as well as conventional treatments. Complex treatment algorithms should be considered as well as specific treatments. In addition, comments are sought for treatment options targeted at disorders such as vascular depression. 2) Study Design. In order to address the full spectrum of public health questions related to treatment resistant depression, conventional randomized clinical trial designs will be complimented by naturalistic studies of treatment resistance in a wide range of clinical practice settings. In addition to controlled comparison of specific interventions, this initiative will include study of treatment algorithms involving sequences of interventions. The use of more complex study designs in an effectiveness model introduces increased operational and methodological complexity. Comments are sought regarding these operational and methodological issues. 4) Ancillary Studies. NIMH wishes to maximize the potential scientific yield of the project by facilitating the conduct of ancillary studies. A number of areas of investigation are possible which may be funded either as part of this initiative or as separate investigator-initiated studies. In particular, a major opportunity exists for the investigation of the genetics of treatment response through collection and characterization of DNA samples from subsets of subjects. Comments on this and other related studies are sought. NIMH welcomes responses from all individuals and organizations on each or all of these questions. Responses should be limited to approximately one (1) page per question, and are due by September 16, 1998. Sources Sought: Interest organizations should submit a capability statement of approximately 10 pages that details the ability to perform the aspects of the effort described above. All proprietary information should be marked as such. Responses will be reviewed only by NIH personnel and will be held in a confidential manner. All respondents are asked to indicate the type and size of your business organization, e.g., Large Business, Small Business, Small Disadvantaged Business, Women-Owned Business, 8(a), Historically Black College or University/Minority Institution (HBCU/MI), educational institution, profit/non-profit hospital, or other nonprofit organization, in their response. Responses should be identified with NIMH-98-RFI-02, and are due by September 16, 1998. Please submit three (3) copies of your response to the attention of: Patricia L. Gibbons, Contracting Officer, Contracts Management Branch, National Institute of Mental Health, NIH, 5600 Fishers Ln., Rm 9C-15, Rockville, MD 20857-8030. Facsimile responses will also be accepted as long as they do not exceed 20 pages in length (301-443-0501). E-mail responses, sent to pgibbons@mail.nih.gov will also be accepted. Posted 08/19/98 (W-SN239019). (0231)

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