Serotonergic Pharmacotherapy for Agitation of Dementia

• Status: Completed
• Trial end date: 2002-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bruce Pollock
• Collaborator: National Institute of Mental Health (NIMH)
• Treatments: Citalopram; Perphenazine

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)