TREATMENT RESISTANT DEPRESSION

Release Date:  December 2, 1998

RFP AVAILABLE:  NIMH-99-DS-0003

P.T.

National Institute of Mental Health

The National Institute of Mental Health (NIMH) proposes to issue a Request for
Proposal (RFP) under Full and Open Competition procedures using Standard Industry
Code 8093.  In recognition of the great public health significance of the problem
of TRD, NIMH plans to undertake a large-scale clinical trial investigating
treatment approaches to TRD.  A five-year base contract with an option for an
additional three years is contemplated.  This contract would fund a major public
health oriented intervention study of treatment approaches for management of TRD
in adults and older persons.  The contractor/coordinating center will plan and
administer a trial assessing the acute and long-term impact of different
treatment algorithms employing broad clinical and functional outcomes in a
diagnostically and demographically heterogeneous population.

Underlying this initiative is the dilemma that confronts the field concerning the
practical limitations of designing a trial of treatment approaches to TRD.  A
large number of treatment options are currently in use as secondary therapy
including numerous augmentation and drug switching strategies. Comparisons of
these treatment modalities having adequate statistical power would require large
numbers of patients.  This problem is compounded by the fact that when using
stringent criteria for the definition of treatment resistance, patient
recruitment is a limiting factor.  Selecting the key questions to be addressed
and designing a trial with sufficient external validity and statistical power
will necessitate a major collaborative effort.

NIMH anticipates that there will be a primary study that will focus on
understanding what interventions (pharmacologic and psychosocial) provide the
best outcomes (both clinical and functional) for patients who fail to respond to
initial treatment of depression.  Additionally, it would address the impact of
other factors on the delivery of and compliance with treatment interventions. 
NIMH envisions that data from the study should be able to inform the provision
of care in broad categories of people with TRD in the community.  Ancillary
studies would contribute to the primary focus but could also consider additional
research issues in TRD.  Request for Proposal (RFP) No. NIMH-99-DS-0003 will be
available on or about December 2, 1998 and the receipt date of proposal on or
about March 2, 1999.  The RFP may be accessed through the NIMH Home Page at
http://www.nimh.nih.gov/grants/indexcon.htm and selecting "NIMH Request for
Proposals (RFP)", and lastly select "NIMH-99-DS-0003."

Please note that the RFP for this requirement will include the Statement of Work,
Deliverables and Reporting Requirements, the Technical Evaluation Criteria, and
proposal preparation instructions.  All information required for the submission
of an offer will be contained in the electronic RFP package.  Following proposal
submission and initial review process, offerors comprising of the competitive
range will be requested to provide additional documentation to the Contracting
Officer.  All responsible sources may submit a proposal that will be considered
by the NIMH.  This advertisement does not commit the Government to award a
contract.

INQUIRIES

Inquiries 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
Email:  [email protected]

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