MODIFICATION
R -- Rapidly-Acting Treatments for Treatment-Resistant Depression (RAPID)
- Notice Date
- 9/22/2010
- Notice Type
- Modification/Amendment
- NAICS
- 541712
— Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute on Drug Abuse, 6101 Executive Boulevard, Room 260 - MSC 8402, Bethesda, Maryland, 20892
- ZIP Code
- 20892
- Solicitation Number
- HHSNIHNIMHRDSS10024
- Archive Date
- 10/22/2010
- Point of Contact
- Marla J. Jacobson, Phone: 3014433775, Bruce E. Anderson, Phone: 3014432234
- E-Mail Address
-
jacobsonmj@mail.nih.gov, ba9i@nih.gov
(jacobsonmj@mail.nih.gov, ba9i@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- This is a Research and Development (R&D) Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding the availability and capability of all qualified sources to perform a potential R & D requirement. Note: A Small Business Sources Sought Notice was previously published on August 11, 2010; Sources Sought number: HHS-NIHM-SBSS-10-001. Background. Major depression is one of the most common and serious disorders treated by mental health practitioners. While there are many pharmacologic, psychotherapeutic, and combination treatment options available to clinicians, many patients with Major Depressive Disorder (MDD) do not respond optimally to the initial treatment offered. When initial treatment is limited to antidepressant medications, approximately 20-30% of patients do not respond. In addition, it has been estimated that as many as 60-70% of depressed patients achieve only a partial remission of their symptoms in response to any initial antidepressant treatment regimen. 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 burden. Despite the enormous public health significance of this problem, systematic research on treatment-resistant depression has yielded only limited success. In particular, the timely and accurate identification of treatment resistant patients has been problematic. It is generally accepted that there is a biologically-determined latency period that delays the onset of response to antidepressant treatment. This latency period is believed to reflect the time required to reach therapeutic drug levels or to achieve adequate intensity of psychotherapy coupled with the time needed for the requisite biochemical and electrophysiological adaptations to occur. Over the last decade, a series of studies has demonstrated the ability of novel approaches -including ketamine hydrochloride 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 exact mechanism(s) of action of these modalities is not clear. The pharmacologic effect of ketamine appears to involve blockade of glutamatergic NMDA receptors and facilitation of AMPA receptors. One research question concerns whether variations in dose levels might produce longer-lasting effects without a significant increase in adverse events (which, to date, have been minimal). Finally, while a recent study has shown that repeated administration of ketamine over several days is well-tolerated, symptoms nevertheless returned within several days of drug discontinuation for almost all patients. While recent research has increased understanding of the mechanism of circadian rhythms and the sleep-wake cycle, the rationale for an association between sleep deprivation and symptom relief also remains unclear. Purpose and Objectives. The National Institute of Mental Health (NIMH) is seeking information on organizations capable of performing this project entitled "Rapidly-Acting Treatments for Treatment-Resistant Depression (RAPID)." The Rapidly-Acting Treatments for Treatment-Resistant Depression (RAPID) initiative seeks to test new compounds (or non-pharmacologic interventions) for treatment-resistant depression which results in a therapeutic response within 72 hours. The outcome of this initiative is also expected to lead to enhanced understanding of underlying mechanisms and development of innovative, rapid treatment approaches for severe and treatment-resistant depression. The specific aims of this initiative are: 1) To establish a network of sites to study "Rapidly-Acting Treatments for Treatment-Resistant Depression" (i.e., the "RAPID-network") that will focus on identifying and testing promising interventions (pharmacologic and/or non-pharmacological) that produce a substantial anti-depressant effect within 48-72 hours of administration. 2) To perform randomized clinical trials testing such promising interventions in a well-characterized cohort of adult patients diagnosed with treatment-resistant MDD. 3) To further elucidate the mechanism(s) underlying successful, rapidly-acting treatments for severe and treatment-resistant depression. Anticipated Period of Performance. It is anticipated that any resulting contract for this requirement will have a period of performance of 5 years. Response Information. In order to respond to this notice, potential sources should briefly discuss their experience and/or ability to perform each of the seven (7) items below. Any organization that believes it has the capability to fulfill this requirement should submit a brief narrative response (5 - 10 pages, single-spaced), indicating previous experience and capabilities related to the described work. Capability statements should describe: (a) staff expertise, including their availability, experience, and formal and other training; (b) current in-house capability and capacity to perform the work; (c) prior completed projects of similar nature; (d) corporate experience and management capability; (e) examples of prior completed Government contracts, references, and other related information (f) any other resources available to support this project. Capable sources should be able to: 1) Perform clinical trials (estimated 1-5 trials) with both pharmacological and non-pharmacological interventions specifically in treatment-resistant depression; each clinical trial shall be an adequately controlled study in patients with treatment-resistant MDD who have not responded to at least two adequate anti-depressant treatment trials (estimated 30-60 subjects per trial). 2) Further study and evaluate in a larger clinical trial interventions that showed efficacy in a previous clinical trial under the RAPID-network. 3) Identify and propose promising interventions for testing through the network. 4) Access proposed compounds (if applicable) from the supplier. If the initial trial is pharmacological, the proposed compound must already have Food and Drug Administration (FDA) Investigational New Drug (IND) approval. 5) Recruit significant numbers of subjects experiencing an episode of treatment-resistant depression from multiple representative sites, and the ability to retain and follow up subjects in an ongoing clinical trial 6) Provide scientific oversight, facilitate collaboration among the investigators, integrate complex protocol management, data acquisition, bio-statistical data analysis and reporting of results from clinical trials involving subjects with treatment-resistant depression. 7) Collaborate with multiple experts and stakeholders (investigators, clinicians, advocates, and consumers) in treatment-resistant depression research. Each response should also include the following Business Information:a. DUNS b. Company name and address c. No. of years in operation d. Type of Company (i.e., Other than small business, for-profit, non-profit, not-for-profit, small business, 8(a), woman owned, veteran owned, etc.) as validated via the Central Contractor Registration (CCR). All offerors must register on the CCR located at http://www.ccr.gov/index.asp e. If small business, applicable NAICS code(s) f. Company Point of Contact, Phone and Email address g. Teaming Arrangements: All teaming arrangements should also include the above-cited information and certifications for each entity on the proposed team. Teaming arrangements are encouraged. Responses to this Sources Sought Notice are due by October 07, 2010, 4:30 PM local time. Responses can be sent by mail, fax, or E-mail to: Marla J. Jacobson Contract Specialist, NIDA Neuroscience COAC *NIMH R&D Contracts Management Branch 6001 Executive Blvd., Rm. 8154 (MSC 9661) Bethesda, MD 20892 [For commercial overnight services use: Rockville, MD 20852] Voice: 301-443-3775 or 301-443-2696 Fax: 301-443-0501 E-mail: jacobsonmj@mail.nih.gov *NIMH R&D contracts are awarded and administered by the National Institute on Drug Abuse (NIDA), Neuroscience Consolidated Operations Acquisition Center (COAC) Disclaimer and Important Notes. This Research and Development Sources Sought Notice is for information and planning purposes only and should not be construed as a commitment by the Government. This is not a solicitation announcement for proposals and no contract will be awarded from this Notice. No reimbursement will be made for any costs associated with providing information in response to this Notice. Capability statements will not be accepted after the due date. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation. Confidentiality. No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).
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