Serotonergic Pharmacotherapy for Agitation of Dementia - Full Text View

Sponsored by:	National Institute of Mental Health (NIMH)
Information provided by:	National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:	NCT00009204

Purpose

This study is a randomized, double-blind, placebo-controlled, fixed dose study currently being conducted on two geropsychiatric units at Western Psychiatric Institute and Clinic. It seeks to evaluate the short-term safety and efficacy of citalopram and perphenazine in the treatment of 112 patients suffering from behavioral disturbances associated with dementia. Findings from this research may directly lead to improved acute pharmacotherapy for psychosis and behavioral problems in patients diagnosed with dementia. Improved treatment of behavioral complications with reduced side effects would reduce excess disability in patients diagnosed with dementia, allowing them to be maintained in the community for greater periods of time.

Condition	Intervention	Phase
Dementia Alzheimer Disease Dementia, Vascular	Drug: Citalopram [Celexa] Drug: Perphenazine [Trilafon]	Phase III

Genetics Home Reference related topics: Alzheimer disease

MedlinePlus related topics: Alzheimer's Disease Dementia

Drug Information available for: Escitalopram Benzetimide Citalopram Citalopram hydrobromide Dexetimide Escitalopram oxalate Perphenazine Perphenazine enanthate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control
Official Title:	Serotonergic Pharmacotherapy for Agitation of Dementia

Further study details as provided by National Institute of Mental Health (NIMH):

Detailed Description:

The principal investigator is conducting an inpatient study at Western Psychiatric Institute and Clinic involving two medications for treatment of emotional and behavioral disturbances that may accompany dementia. In this study, 112 patients will be enrolled for up to 17 days in order to investigate the safety and effectiveness of both medications. Forty-two of these patients will be given a recently FDA-approved antidepressant medication called citalopram and 42 will receive one of our current, usual antipsychotic medications called perphenazine. An additional 28 patients will be given non-active placebo capsules. Which treatment a patient is given during the study will be determined by chance. Findings from this investigation may directly lead to the improvement of symptoms such as: agitation, hostility, suspiciousness, hallucinations, and unusual thoughts. Improved treatment of problematic behaviors and a decrease in medication-associated side effects would enable dementia patients to be cared for in their home environments for longer periods of time.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Meets DSM-IV criteria for diagnosis of dementia of the Alzheimer's type (AD), Vascular dementia (VD), mixed (AD and VD) or dementia NOS (Not Otherwise Specified)
Presents with psychosis or behavioral problems severe enough to endanger the patient's health, well-being or safety, as evidenced by a score of at least 3 (moderate) on one of the Neurobehavioral Rating Scale (NBRS) agitation items (8,11,14) or psychosis items (16,18,20) and are not secondary to physical illness nor amenable to environmental optimization
Able to participate in study evaluations and ingest oral medication
Has next of kin or a guardian available to consent to patient's participation.

Exclusion Criteria:

Has an unstable medical illness including significant cardiac (specifically bradycardia with ventricular rate below 50), renal, hepatic, or neurological illness (especially Parkinson's disease) other than dementia
Meets DSM-IV criteria for Delirium upon admission to Western Psychiatric Institute and Clinic
Has been medicated within 4 weeks of protocol admission with fluoxetine or 2 weeks with a monoamine oxidase inhibitor (patients will undergo a monitored psychotropic drug washout prior to entering the protocol)
Is currently being treated with cognitive enhancing drugs (Tacrine or Aricept) or any experimental drug
Has a concurrent diagnosis of schizophrenia, bipolar disorder, or major depression
Has preexisting orthostatic hypotension (with > 20 mmHg change from sitting to standing pressure)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00009204

Locations

United States, Pennsylvania
University of Pittsburgh Western Psychiatric Institute and Clinic
Pittsburgh, Pennsylvania, United States, 15213

Sponsors and Collaborators

National Institute of Mental Health (NIMH)

Investigators

Principal Investigator:

Bruce G. Pollock, M.D., Ph.D.

Western Psychiatric Institute and Clinic

More Information

Study ID Numbers:	R01 MH59666-01, IA0014, DSIR GT-GP
Study First Received:	January 23, 2001
Last Updated:	November 18, 2005
ClinicalTrials.gov Identifier:	NCT00009204
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):

Behavioral problems
Agitation

Study placed in the following topic categories:

Arterial Occlusive Diseases
Alzheimer Disease
Vascular Diseases
Central Nervous System Diseases
Psychomotor Agitation
Arteriosclerosis
Brain Diseases
Neurodegenerative Diseases
Citalopram
Intracranial Arterial Diseases
Cerebrovascular Disorders

Cognition Disorders
Intracranial Arteriosclerosis
Dopamine
Delirium, Dementia, Amnestic, Cognitive Disorders
Perphenazine
Mental Disorders
Dementia, Vascular
Dexetimide
Dementia
Delirium

Additional relevant MeSH terms:

Neurotransmitter Agents
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
Nervous System Diseases
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Depressants
Dopamine Antagonists

Antipsychotic Agents
Pharmacologic Actions
Therapeutic Uses
Cardiovascular Diseases
Dopamine Agents
Tauopathies
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 16, 2009