Serotonergic Pharmacotherapy for Agitation of Dementia

NCT00009204 | Completed Phase 3

• 3 other identifiers: R01MH059666-01IA0014DSIR GT-GP
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dementia; Alzheimer Disease; Dementia, Vascular

Keywords

Behavioral problems; Agitation

Interventions

Citalopram [Celexa] DRUG

Perphenazine [Trilafon] DRUG

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Bruce Pollock: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

University of Pittsburgh Western Psychiatric Institute and Clinic

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Dementia; Alzheimer Disease; Dementia, Vascular; Problem Behavior; Psychomotor Agitation

Interventions

Citalopram; Perphenazine

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Tauopathies; Neurodegenerative Diseases; Cerebrovascular Disorders; Intracranial Arteriosclerosis; Intracranial Arterial Diseases; Leukoencephalopathies; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Behavioral Symptoms; Behavior; Child Behavior; Dyskinesias; Neurologic Manifestations; Psychomotor Disorders; Neurobehavioral Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Aberrant Motor Behavior in Dementia

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Phenothiazines; Sulfur Compounds; Heterocyclic Compounds, 3-Ring

Study Officials

• Bruce G. Pollock, M.D., Ph.D.

  Western Psychiatric Institute and Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 23, 2001
• First Posted: January 24, 2001
• Study Start: September 1, 1995
• Primary Completion: April 1, 2000
• Study Completion: April 1, 2002
• Last Updated: June 16, 2017

Record last verified: 2017-06

Locations

US (1)