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Serotonergic Pharmacotherapy for Agitation of Dementia
This study has been completed.
First Received: January 23, 2001   Last Updated: November 18, 2005   History of Changes
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: Perphenazine Benzetimide Perphenazine enanthate Dexetimide Citalopram hydrobromide Citalopram Escitalopram Escitalopram oxalate
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
Investigators
Principal Investigator: Bruce G. Pollock, M.D., Ph.D. Western Psychiatric Institute and Clinic
  More Information

No publications provided

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     History of Changes
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:
Neurotransmitter Agents
Psychotropic Drugs
Psychomotor Agitation
Arteriosclerosis
Neurodegenerative Diseases
Brain Diseases
Cerebrovascular Disorders
Intracranial Arterial Diseases
Intracranial Arteriosclerosis
Dopamine
Mental Disorders
Dementia, Vascular
Dementia
Dexetimide
Delirium
Arterial Occlusive Diseases
Tranquilizing Agents
Alzheimer Disease
Vascular Diseases
Central Nervous System Diseases
Central Nervous System Depressants
Antipsychotic Agents
Citalopram
Cognition Disorders
Delirium, Dementia, Amnestic, Cognitive Disorders
Perphenazine
Dopamine Agents

Additional relevant MeSH terms:
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Arteriosclerosis
Neurodegenerative Diseases
Brain Diseases
Intracranial Arterial Diseases
Cerebrovascular Disorders
Intracranial Arteriosclerosis
Mental Disorders
Therapeutic Uses
Dementia, Vascular
Cardiovascular Diseases
Dementia
Arterial Occlusive Diseases
Tranquilizing Agents
Nervous System Diseases
Alzheimer Disease
Vascular Diseases
Central Nervous System Diseases
Central Nervous System Depressants
Dopamine Antagonists
Antipsychotic Agents
Pharmacologic Actions
Delirium, Dementia, Amnestic, Cognitive Disorders
Perphenazine
Dopamine Agents
Tauopathies
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 06, 2009