TREATMENT FOR BIPOLAR DISORDER

Release Date:  April 3, 1998

RFP AVAILABLE:  NIH-NIMH-98-DS-0001

P.T.

National Institute of Mental Health

The National Institute of Mental Health proposes to issue a solicitation (RFP)
No. NIMH-98-DS-0001 entitled "Treatment for Bipolar Disorder" as Full and Open
Competition under SIC Code 8093. This will be the initial award for this
requirement. The purpose of this contract is to launch a major public study that
will provide data to optimize treatment of bipolar disorder in adults and older
persons. The study will assess the long-term impact of different treatments,
either individually or in combination, on a broad range of clinical and
functional outcomes in a diagnostically and demographically heterogeneous
population.  Data from this study are expected to inform treatment practice in
community populations.

The primary study should focus on understanding what interventions (pharmacologic
and psychosocial) provide the best outcomes (both clinical and functional) for
different types of people and various stages of the disorder.  In addition, it
should address the impact of other factors on the delivery of and compliance with
treatment interventions.  Data from the study should be able to inform the
provision of care in broad categories of people with bipolar disorder in the
community.  Ancillary studies may contribute to the primary focus but they could
also consider additional research issues in bipolar disorder.

Through the primary intervention trial or through ancillary studies, the focus
should be on patients that are severely impacted by the illness and who are often
excluded from traditional research trials due to their complicating diagnostic
comorbidities and the need for multiple medications.  It should give
consideration to patients who are unstable, who have rapid cycling or mixed
states.  It should include patients with complicating diagnostic comorbidities
(substance abuse, other mental disorders, other physical or neurological
illnesses), the need for multiple medications, and a wide variety of demographic
characteristics (age, sex, race or ethnicity, residential setting).  It should
consider patients who experience breakthrough depression and if or how
antidepressants should be used as adjuncts.  It should determine if, when, and
how to add an antipsychotic medication and for how long to continue it in
patients with hypomania.  There should be systematic evaluation of complex
combination therapies, both for their potential therapeutic advantage as well as
any adverse effect advantage.  If the first treatment fails, what is the next
best treatment?  How are refractory patients best treated?  What are the risks
for discontinuation syndromes, and how can they be avoided?  When a new
medication is made available, where does it best fit in a stepwise medication
algorithm and for whom?

This initiative is based on a public health model of intervention research.  The
overall objective of this initiative is to develop a research-validated
multimodal approach to the acute treatment and long-term management of bipolar
disorder in a representative sample of patients selected from a broad range of
health care settings.  This treatment approach is expected to target recovery
from the illness and the optimization of function, not simply stabilization of
acute symptoms.

The NIMH plans to award a five year cost-reimbursement contract, and plans to
make the award by September 30, 1998. It is anticipated that one award will be
made to a single coordinating center to plan and administer the initiative.

Request for Proposal (RFP) No. NIMH-98-DS-0001 will be only electronically
available on or about March 31, 1998 and the receipt date of proposal on or about
June 8, 1998.  The RFP may be accessed through the NIMH Home Page by using the
following instructions: access the home page at http://www.nimh.nih.gov, first
select "Grants and Contracts", then select "NIMH Request for Proposals (RFP),"
and lastly select "NIMH-98-DS-0001."

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:

David J. Eskenazi, Contracting Officer
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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