TREATMENT RESISTANT DEPRESSION

Release Date:  September 4, 1998

RFI AVAILABLE:  NIMH-98-RFI-02

P.T.

National Institute of Mental Health

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 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 [email protected] will
also be accepted.

INQUIRIES

Inquiries concerning this Notice may be directed to:

Patricia L. Gibbons
Contracts Management Branch
National Institute of Mental Health
5600 Fishers Lane, Room 9C-15
Rockville, MD  20857-8030
Telephone:  (301) 443-2696
FAX:  (301) 443-0501
Email:  [email protected]

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