Notice Number: NOT-MH-06-128
Key Dates
Release Date: December 11, 2006
Response Date: February 9, 2007
Issued by
National Institute of Mental Health (NIMH) ( http://www.nimh.nih.gov )
The National Institute of Mental Health (NIMH) is seeking input from the clinical research community, mental health professionals, patient advocates and individuals living with mental illnesses, private and public mental health service systems and providers, the pharmaceutical and biotechnology industry, and other interested groups about important public mental health research questions that could be addressed using the infrastructure provided by three NIMH clinical research networks - the Bipolar Trials Network (BTN), the Depression Trials Network (DTN), and the Schizophrenia Trials Network (STN).
Background
In 1998, NIMH began a major initiative to expand the evidence base available to clinicians in the community to guide treatment of mental illnesses. NIMH issued contracts for clinical trials to compare the effectiveness of atypical antipsychotic medications in schizophrenia and in Alzheimer's disease (Clinical Antipsychotic Trials of Intervention Effectiveness -- CATIE), to develop treatment alternatives for managing treatment-resistant depression (Sequenced Treatment Alternatives to Relieve Depression -- STAR*D), and to enhance treatment for bipolar disorder (Systematic Treatment Enhancement Program for bipolar disorder -- STEP-BD). These three projects aimed to address critical public mental health questions that could only be answered by large-scale, government-sponsored, randomized clinical trials. Each trial focused on studying effectiveness in real world clinical situations by enrolling people with chronic mental illnesses, many of whom had co-occurring medical conditions or substance abuse problems, and going beyond symptom ratings to look at long-term functional outcomes. Results from these trials are now becoming available and are being regarded as landmark studies that will significantly inform both clinical practice and health care policy. See :
http://www.nimh.nih.gov/healthinformation/catie.cfm (CATIE)
http://www.nimh.nih.gov/healthinformation/stard.cfm (STAR*D)
http://www.nimh.nih.gov/healthinformation/stepbd.cfm (STEP-BD)
The rich and extensive networks of clinics and investigators that evolved from each trial provide an unprecedented opportunity for NIMH to continue to facilitate vital clinical research in major mental illnesses. Recognizing the time, cost, and effort that went into developing the infrastructure for each of these large effectiveness trials, NIMH felt that it would be most cost effective to continue the groups that had forged efficient, effective, collegial, and collaborative relationships by providing ongoing support to carry out new practical clinical trials or other clinical research. Each of the three investigative teams (BTN, DTN, and STN) receives funding for their clinical sites and coordinating centers, with the expectation that distinct research projects to be carried out on the Networks will be supported through research grants, contracts, private sources, or a combination of public-private sources.
In keeping with the goals of the NIH Roadmap initiative on re-engineering the clinical research enterprise http://nihroadmap.nih.gov/clinicalresearch/overview-networks.asp , the networks are positioned to rapidly conduct high-quality clinical studies that address multiple-research questions designed to improve the public health. They are poised to address the mental health questions that cannot and are not being addressed by non-government entities, as well as research questions that are beyond the scope and timeframe typical of the regular research grant process.
Research conducted on the networks must be informed by broad scientific and public input. In keeping with a major theme in the NIMH's National Advisory Mental Health Council (NAMHC) Council Workgroup Report: The Road Ahead: Research Partnerships to Transform Services http://www.nimh.nih.gov/council/advis.cfm , NIMH seeks the perspective of its multiple stakeholders to ensure that the right questions are being addressed. This request for information is intended as a primary way to solicit suggestions on the most important future research directions and projects for the networks. These suggestions will be reviewed by a workgroup of the National Advisory Mental Health Council (NAMHC). The workgroup will report its findings on the top research areas to the full NAMHC for consideration by NIMH.
Request for Information
The NIMH solicits input from any and all organizations and individuals interested in clinical research in adult bipolar disorder, depression, and schizophrenia for important public mental health research questions and topics that can use the infrastructure provided by the research networks. Examples of research areas include, but are not limited to, the following:
- improving day- to-day care of people living with mental illnesses,
- health care policy research and optimization of resource allocations,
- increasing the ability of clinicians to personalize and individualize care,
- improving long-term functional outcomes,
- elucidating treatment mechanisms of action and/or illness pathophysiology,
- testing new treatments with unique mechanisms of action.
Responses should be no more than 1000 words in length and should:
- specify which network(s), BTN, DTN, and STN, would be involved;
- explain the public mental health significance or scientific opportunity of the problem being addressed; and
- describe a specific research question to be addressed and, if possible, outline suggested protocol components, e.g., relevant treatment and comparison conditions, estimated sample size and time scale.
Responses
This request for information is for planning purposes only and shall not be construed as a solicitation for applications or as an obligation on the part of the government. The government will not pay for the preparation of any information submitted or for the government's use of that information.
Responses will be accepted through Friday, February 9, 2007. Electronic responses are preferred and may be addressed to [email protected] (Please include the Notice number NOT-MH-06-128 in the subject line). Responses may also be sent by letter or FAX to the following address:
NIMH Networks
Division of Services and Intervention Research,
6001 Executive Boulevard, Room 7159, MSC 9629,
Rockville, Maryland 20852
FAX: 301-443-0118
Receipt of responses will be acknowledged. No basis for claims against the government shall arise as a result of response to this request for information, or in the government's use of such information, either as part of our evaluation process or in developing specifications for any subsequent announcement. The general content of responses may be shared anonymously with the NIMH's NAMHC and clinical trials workgroup advisors.
and Human Services (HHS)
