DEPRESSION IN LATE LIFE NIH GUIDE, Volume 21, Number 8, February 28, 1992 PA NUMBER: PA-92-44 P.T. 34 Keywords: Depression Aging/Gerontology Etiology Epidemiology Social Psychology National Institute of Mental Health PURPOSE 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. HEALTHY PEOPLE 2000 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). ELIGIBILITY REQUIREMENTS 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 apply. MECHANISMS OF SUPPORT 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 award. RESEARCH OBJECTIVES Background 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. STUDY POPULATIONS SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDY POPULATIONS 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 Subjects. 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. APPLICATION PROCEDURES 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** REVIEW PROCEDURES 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 announcement 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 subjects 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. AWARD CRITERIA 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. INQUIRIES 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 contact: 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 AUTHORITY AND REGULATIONS 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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