NIH GUIDE, Volume 21, Number 8, February 28, 1992

PA NUMBER:  PA-92-44

P.T. 34






  Social Psychology 

National Institute of Mental Health


The purpose of this program announcement (PA) is to stimulate the

development of new research related to the diagnosis and treatment of

depression in late life.  At the National Institutes of Health (NIH)

Consensus Development Conference on the Diagnosis and Treatment of

Depression in Late Life, held November 4-6, 1991, progress in the

development of the scientific knowledge base was reviewed.  Significant

attention was paid to the epidemiology, pathogenesis, pathophysiology,

and treatment of depression in geriatric patients and to issues of

prevention and symptomatic management.  In addition, the Consensus

Panel identified a number of research issues as deserving special

attention at this time (see Research Objectives, below).  These issues,

and others of significant programmatic interest to the National

Institute of Mental Health (NIMH), represent the major focus of this

program announcement.


The Public Health Service (PHS) is committed to achieving the health

promotion and disease prevention objectives of "Healthy People 2000,"

a PHS-led national activity for setting priority areas.  This PA,

Depression in Late Life, is related to the priority areas of mental

health and mental disorders, and older adults.  Potential applicants

may obtain a copy of "Healthy People 2000" (Full Report:  Stock No.

017-001-00474-0) or "Healthy People 2000" (Summary Report:  Stock No.

017-001-00473-1) through the Superintendent of Documents, Government

Printing Office, Washington, DC 20402-9325 (telephone:  202-783-3238).


Applications may be submitted by any public and private, non-profit and

for-profit organization such as a university, college, hospital,

laboratory, units of State or local governments, and eligible agencies

of the Federal Government.  Women and minorities are encouraged to



In addition to the traditional research project grant (RO1), other

mechanisms that are available include the First Independent Research

Support and Transition (FIRST) Award (R29) and the small grant (RO3).

Specialized announcements are available from Anne Cooley, Room 9-97,

5600 Fishers Lane, Rockville, Maryland 20857, telephone:  301-443-4673.

Terms and Conditions of Support

Grant funds may be used for expenses clearly related and necessary to

conduct the proposed project, including both direct costs and allowable

indirect costs.  Applicants must show any special administrative or

programmatic limitations on the types of activities for which funds may

be used, e.g., maximum total award each year, maximum for particular

types of costs such as stipends or requirements to attend periodic

meetings of grantees.  In general, funds may not be used to establish

or operate a treatment, rehabilitation, or other service program.

Grants must be administered in accordance with the PHS Grants Policy

Statement (revised October 1, 1990).

Federal regulations at 42 CFR Part 52, "Grants for Research Projects,"

and Title 45 CFR Parts 74 and 92, generic requirements concerning the

administration of grants, are applicable to this award.

Period of Support

Support for regular research grants may be requested for a period of up

to five years (renewable for subsequent periods). Annual awards will be

made subject to continued availability of funds and progress achieved.

A competing supplemental application may be submitted during an

approved period of support to expand the scope or protocol of a project

during the approved period.  A competing continuation (i.e., renewal)

application may be submitted before the end of an approved period of

support to continue a project.

Availability of Funds

In fiscal year 1993, the NIMH estimates that approximately $7,000,000

will be available to support 10-12 new and 25 continuation grants under

this announcement.  The expected average amount of an award is

approximately $180,000.  However, the amount of funding available will

depend on appropriated funds and program priorities at the time of




Depressive illness is a major public health problem among the elderly.

Late-onset disease, that is, depression with first onset at age 65 or

over, as well as recurrent episodes of adult onset depression in

geriatric patients, constitute significant sources of heterogeneity in

this growing segment of the population.  With increasing longevity and

the aging of the "baby boom" generation, the number of people 65 years

and older will increase by 40 percent between 1984 and 2010 and will

represent nearly 14 percent of the general U. S. population.  Elderly

patients with depression are already overrepresented in hospitals,

outpatient clinics, and institutions.  The 1985 National Nursing Home

Survey found that 25 percent of nursing home residents had major

depression, not including the 63 percent who were cognitively impaired.

There is substantial evidence that the prognosis of depression in the

elderly and treatment response may be poorer than in younger patients.

Although pharmacotherapy is effective in older patients, it may not be

as effective as it is in younger adults, with less than a 50-percent

response rate.  Evidence for the efficacy of psychotherapy in older

depressed adults has emerged only recently. Reasons for these

differences remain to be explicated but include the possibilities that

depression in late life is different in phenomenology and natural

history; that structural and metabolic derangements, concurrent medical

illness, or personality may complicate the clinical course and response

to treatment; that the physiological effects of aging per se may

increase sensitivity to toxic effects or decrease sensitivity to

therapeutic effects of medication; or that significant age-related

pharmacokinetic and pharmacodynamic effects may impair response.  The

increased prevalence of suicide in older white males, issues of

bereavement-related depression, and depression among residents of

long-term care facilities represent significant concerns.

Research addressing issues of depression in late life was the subject

of the November NIH Consensus Development Conference.  Interested

individuals may obtain a copy of the Panel Report of the Consensus

Development Conference on the Diagnosis and Treatment of Depression in

Late Life through the Office of Medical Applications of Research,

National Institutes of Health, 9000 Rockville Pike, Bethesda, Maryland

20892 (Telephone 301/496-1144).  This PA derives directly from the

recommendations for future research

identified by this conference.

Research Goals and Scope

NIMH encourages applicants to study the broad range of issues related

to depression in late life.  These include: epidemiology; clinical,

etiological, and biological heterogeneity including subsyndromal and

delusional forms; course and outcome; comorbidity; quality of life;

cohort effects; biological, personality, and psychosocial correlates;

brain structural and functional correlates; pharmacologic and other

biological treatments, psychotherapeutic, and combined approaches to

acute, continuation, and maintenance treatment; treatment non-response;

pharmacokinetics, toxicity, and compliance in treatment;

protective/innoculating factors; prevention of recurrence and of

initial episodes; availability and effectiveness of services; and

considerations relating to suicide, bereavement, and residential care

facilities and settings.

The Consensus Panel identified the following research issues as

deserving special attention at this time:

Improvement of the diagnosis and identification of elderly persons most

likely to benefit from treatment

Clarification of the relationship between subcortical brain

abnormalities, depressive and cognitive symptomatology, and early-

versus late-onset depression in the elderly

Studies of the pharmacokinetic differences in the very old and in

ethnic minorities, with special attention to the prognostic value of

metabolic subtyping

Research on the relationships between depression and physical illness,

including how psychological factors can exacerbate physical conditions

Initiation of prospective longitudinal and cross-sequential studies to

identify general risk factors (including contextual and event-related

life stress) and those specific deficits in the elderly (e.g., sensory

loss) and describe the course of depression

Exploration of the basis for differential occurrence of depression and

suicide rates in demographic subgroups

Determination of approaches to long-term treatment, with particular

attention to the efficacy of electroconvulsive therapy (ECT) as a

continuation and maintenance treatment in late-life depression

Study of the treatment of pathological grief, including assessment of

the efficacy of psychological and pharmacological treatments, and when

in the course of grief they should be used

Conduct of clinical trials and observational studies of treatment in

the very old, the elderly in minority and underserved communities and

in institutional settings, and the elderly with medical illness

Development and evaluation of psychosocial treatments, including

marital or family therapy that are specifically linked to the needs of

the elderly; determination of how psychosocial and biological

treatments may complement or provide alternatives to each other

Evaluation of demonstration projects focused on innovative models of

care delivery, particularly those that emphasize coordinated services

and outreach efforts to depressed elderly people

Development of long-term clinical trials with broad-based assessment of

outcome (including economic and social impact) to determine the extent

to which effective recognition and treatment benefit patients, their

families, and society.

The NIMH encourages creative collaboration between research centers,

particularly academic sites, and the public centers where many severely

ill patients receive care.  The advances made at academic research

centers are slow to make their way to the public centers because of the

lack of collaboration between the sites.  Through the general impact of

introducing scientific expertise and interests and through targeted

research studies, stronger research/public partnerships could promote

significant improvements in clinical care.

Applicants from institutions that have a General Clinical Research

Center (GCRC) funded by the NIH National Center for Research Resources

or a Mental Health Clinical Research Center (MHCRC) may wish to

identify the GCRC or MHCRC as a resource for conducting the proposed

research.  In such a case, a letter of agreement from either the GCRC

or MHCRC program director or principal investigator could be included

with the application.





Applications/proposals for ADAMHA grants and cooperative agreements are

required to include both women and minorities in study populations for

clinical research, unless compelling scientific or other justification

for not including either women or minorities is provided.  This

requirement is intended to ensure that research findings will be of

benefit to all persons at risk for the disease, disorder, or condition

under study.  For the purpose of these policies, clinical research

involves human studies of etiology, treatment, diagnosis, prevention,

or epidemiology of diseases, disorders or conditions, including but not

limited to clinical trials; and minorities include U.S. racial/ethnic

minority populations (specifically:  American Indians or Alaskan

Natives, Asian/Pacific Islanders/Blacks, and Hispanics).

ADAMHA recognizes that it may not be feasible or appropriate in all

clinical research projects to include representation of all the full

array of U.S. racial/ethnic minority populations.  However, all

researchers are urged to assess carefully the feasibility of including

the broadest possible representation of minority groups.

Applications should include a description of the composition of the

proposed study population by gender and racial/ethnic group, and the

rationale for the number and kinds of people selected to participate.

This information should be included in the form PHS 398 in Section 2,

A-D, of the Research Plan and summarized in Section 2, E, Human


Applications should include in their study design gender and/or

minority representation appropriate to the scientific objectives of the

work proposed.  If representation of women or minorities in sufficient

numbers to permit assessment of differential effects is not feasible or

is not appropriate, the reasons for this must be explained and

justified.  The rationale may relate to the purpose of the research,

the health of the subjects, or other compelling circumstances (e.g., if

in the only study population available there is a disproportionate

representation in terms of age distribution, risk factors,

incidence/prevalence, etc., of one gender or minority/majority group).

If the required information is not contained within the application,

the application will be returned.  Peer reviewers will address

specifically whether the research plan in the application conforms to

these policies.  If gender and/or minority representation/justification

are judged to be inadequate, reviewers will consider this as a

deficiency in assigning the application a priority score.

All applications/proposals for clinical research submitted to ADAMHA

are required to address these policies.  ADAMHA funding components will

not award grants that do not comply with these policies.

Protection of Human Subjects

The Department of Health and Human Services has regulations for the

protection of human subjects and has developed additional regulations

for the protection of children.  A copy of these regulations (45 CFR

46, Protection of Human Subjects) and those pertaining specifically to

children are available from the Office of Protection from Research

Risks, National Institutes of Health, Bethesda, Maryland  20892,

telephone (301) 496-7041.  Specific questions concerning protection of

human subjects in research may be directed to NIMH staff members listed

under Further Information.


Applicants are to use the grant application form PHS 398 (rev. 9/91).

The number and title of this PA-92-44 must be typed in item number 2 on

the face page of the PHS application form.

Applications kits containing the necessary forms and instructions may

be obtained from business offices or offices of sponsored research at

most universities, colleges, medical schools, and other major research

facilities.  If such a source is not available, the following office

may be contacted for the necessary application materials:

Grants Management Branch

National Institute of Mental Health

5600 Fishers Lane, Room 7C-05

Rockville, MD  20857

Telephone:  (301) 443-4414

The signed original and five legible copies of the completed

application should be sent to:

Division of Research Grants

National Institutes of Health

Westwood Building, Room 240

Bethesda, MD  20892**


Applications will be reviewed for scientific and technical merit by an

initial review group (IRG) composed of primarily non-Federal scientific

experts.  Final review is by the appropriate national advisory council.

Summary statements of IRG discussions are sent to applicants as soon as

possible following IRG review.

Review Criteria

o  Significance of research objectives to public health goals of the


o  Adequacy of theoretical framework of the proposed research and

appropriateness of research methods

o  Scientific merit of the design

o  Adequacy of facilities and core resources

o  Adequate representation of women and minorities

o  Adequacy of proposed procedures for protecting human and animal


o  Appropriateness of the budget

Receipt and Review Schedule

Applications will be accepted in accordance with the usual receipt

dates for applications:

Receipt of          Initial             Advisory       Earliest

Applications        Review           Council Review    Award Date

Feb 1/Mar 1*        June                 Sep/Oct       Dec 1

Jun 1/Jul 1*        Feb                  Oct/Nov       Apr 1

Oct 1/Nov 1*        May                  Feb/Mar       Jul 1

* Amended applications and competing continuation the exception of

center applications.  All center applications are to be submitted on

the earlier dates.

Applications arriving after the above receipt dates are subject to

assignment to the next review cycle or may be returned to the applicant

without review if requested by the applicant.


Applications recommended for approval by the appropriate National

Advisory Council will be considered for funding on the basis of overall

scientific and technical merit of the research as determined by peer

review, program needs and balance, and availability of funds.


Applicants are encouraged to discuss their planned research with NIMH

staff before submitting a formal grant application.  Further

information may be obtained from:

Barry D. Lebowitz, Ph.D.

Chief, Mental Disorders of the Aging Research Branch

Division of Clinical Research

National Institute of Mental Health

Parklawn Building, Room 7-103

5600 Fishers Lane

Rockville, MD  20857

Telephone:  (301) 443-1185

For further information on grants management issues, applicants may


Stephen J. Hudak

Chief, Grants Management Section

National Institute of Mental Health

Parklawn Building, Room 7C-23

5600 Fishers Lane

Rockville, MD  20857

Telephone:  (301) 443-4456


This program is described in the Catalog of Federal Domestic Assistance

No. 93.242.  Applications will be accepted under the authority of

Section 301 of the Public Health Service Act, P.L. 78-410, as amended,

72 U.S.C. 241, and subject to availability of funds.  This announcement

is not subject to the intergovernmental review requirements of

Executive Order 12372, as implemented through DHHS regulations at 45

CFR Part 100.


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