Notice Number: NOT-MH-12-021
Key Dates
Release Date: April 2, 2012
Response Date: June 30, 2014
Issued by
National Institute of Mental Health (NIMH)
Purpose
The National Institute of Mental Health (NIMH) recently awarded Contract #HHSN271201100006I entitled, “Rapidly-Acting Treatments for Treatment-Resistant Depression (RAPID)” to the Massachusetts General Hospital (The General Hospital Corp.), to investigate novel interventions with rapidly-acting antidepressant effect (demonstrable clinical improvement within 72 hours of administration) for treatment-resistant depression.
The purpose of this Request for Information (RFI) is to invite interested parties to submit information describing promising novel intervention strategies (pharmacological or non-pharmacological) that provide preliminary evidence of producing a substantial anti-depressant effect within 72 hours of initial administration, in treatment resistant depression.
Background
Depression is one of the most common and serious disorders treated by mental health practitioners. Although there are many pharmacologic, psychotherapeutic, and combination treatment options available to clinicians, many patients with depression do not respond optimally to the initial treatment offered. When initial treatment is limited to antidepressant medications, approximately 33% of patients achieve remission. Even after multiple, sequential interventions only about 50% of patients achieve complete remission. Because of the substantial mortality and morbidity associated with inadequate treatment, treatment-resistant depression is a major public health problem. The scope of this problem is vast both in terms of the numbers of affected individuals and the resultant societal and economic burdens.
Over the last decade, a series of studies has demonstrated the ability of novel approaches – including ketamine and sleep deprivation therapy – to provide significant amelioration of symptoms within a few hours. However, symptoms typically return within a period of days after discontinuation of the acute intervention. The goal of the RAPID program is to help accelerate development of rapid-onset antidepressant treatment. The outcome of the RAPID program could be expected to lead to an enhanced understanding of the underlying mechanisms of depression and the development of innovative, rapidly-acting treatment approaches for treatment-resistant depression.
Information Sought
NIMH invites companies, scientists, and/or other interested parties to recommend promising novel intervention strategies (pharmacological or non-pharmacological) that provide preliminary evidence of producing a substantial anti-depressant effect within 72 hours of initial administration, in treatment resistant depression, for potential inclusion in the RAPID program.
Companies, scientists, and/or other interested parties recommending such intervention strategies, should provide the rationale supporting the concept as a rapidly-acting anti-depressant intervention strategy. The rationale could include, but not be limited to, the following non-confidential description (NCD) and information:
- A review of the recommended intervention (e.g., preclinical studies, mechanism of action, pharmacokinetics, human safety data).
- Preliminary data (e.g., pilot human efficacy data) supporting a rapidly-acting effect of the recommended intervention.
- Rationale for administration, dosage, and/or duration of the recommended intervention.
If a recommended intervention is considered for testing under the RAPID program, the Contractor will work with the provider to address and resolve any relevant intellectual property issues.
The NIMH welcomes any additional information related to the proposed intervention that the respondent wishes to submit.
Confidentiality
Responses to this RFI are voluntary. It is important to emphasize that this notice is not a funding opportunity. Results will be reviewed by the NIMH, the RAPID Interventions Selection Committee, and the RAPID Steering Committee on an ongoing basis. Proprietary, classified, confidential, or sensitive information should not be included in your response. The Government reserves the right to use any non-proprietary technical information in summaries of the state of the science, and any resultant solicitation(s). The NIH may use the information gathered to develop grant, contract, or other funding priorities and initiatives.
How to Submit a Response
Responses to this RFI will be accepted through June 30, 2014. Comments must be submitted electronically to [email protected]. You will receive an electronic acknowledgement of receipt of your response, but will not receive individualized feedback on any suggestions.Inquiries
Inquiries regarding this Notice may be directed to:
Mi Hillefors, M.D., Ph.D.
Division of Adult Translational Research and Treatment Development
National Institute of Mental Health
6001 Executive Boulevard, Room 7125, MSC 9632
Bethesda, MD 20852
Telephone: (301) 443-1692
FAX: (301) 443-1425
Email: [email protected]
and Human Services (HHS)
