# TREATMENT OF AGITATION IN THE NURSING HOME

> **NIH NIH R01** · HEBREW HOME OF GREATER WASHINGTON · 1992 · $154,151

## Abstract

Agitation is a major problem for nursing home residents and for their
caregivers.  It is frequently treated with psychotropic drugs, although
their efficacy for agitation has not been conclusive, and the drugs are
associated with increased risks of adverse effects.

The proposed study aims to explore the effectiveness of psychotropic
drugs for the treatment of agitation in nursing home residents through a
placebo-controlled, double-blind random assignment, parallel group, trial
of withdrawal of medications.  The effects of drug withdrawal on levels
of agitation, on somatic adverse effects, and on neuropsychological
functioning will be examined for three psychotropic drugs: haloperidol,
thioridazine, and lorazepam.  In addition, the study will explore the
following questions:

a) Is there a subgroup of residents who appear to benefit from
psychotropic drugs? Are they characterized by use of a specific drug? or
by type of agitation? or by other resident characteristics?

b) Is functioning other than agitation affected by the withdrawal of
psychotropic drug use?

c) Does the response to withdrawal of these psychotropic drugs change
over the course of tapering and withdrawal? Can the final outcome of
discontinuation be predicted from an earlier assessment during the
tapering phase?

For each of the drugs, fifty residents receiving the drug will be
randomly divided into two groups: those who continue their medication and
those who will gradually receive placebo instead.  Residents will be
evaluated by nursing staff and by the research team at baseline, a week
after beginning of withdrawal, and six weeks after administration of
placebo.  Drug levels in the blood and prolactin levels will also be
assessed at these times.  All staff and research personnel will be blind
to the medication status until the end of the trial.

Since recent OBRA regulations require nursing homes to increase
monitoring of psychotropic drugs, and decrease their usage, there is an
urgent need to study the impact of withdrawal of these drugs, and the
conditions under which they may be effective.  The proposed study will
address some of these issues.

## Key facts

- **NIH application ID:** 3122136
- **Project number:** 1R01AG010172-01A1
- **Recipient organization:** HEBREW HOME OF GREATER WASHINGTON
- **SAM.gov UEI:** RY46DLNQAN83
- **Principal Investigator:** Jiska Cohen-Mansfield
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 1992
- **Award amount:** $154,151
- **Award type:** 1
- **Project period:** 1992-08-18 → 1996-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/3122136

## Citation

> US National Institutes of Health, RePORTER application 3122136, TREATMENT OF AGITATION IN THE NURSING HOME (1R01AG010172-01A1). Retrieved via MORVS 2026-10-25 from https://api.morvs.ai/grant/nih/3122136. Licensed CC0.

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