NCT00898807

Citalopram for Agitation in Alzheimer's Disease

A Multi-Center Randomized Placebo-Controlled Clinical Trial Study of Citalopram for the Treatment of Agitation in Alzheimer's Disease

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 186 (actual)
• Sponsor: JHSPH Center for Clinical Trials · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety and efficacy of citalopram for agitation in Alzheimer's dementia.

Detailed description

This study is designed to examine the efficacy and safety of citalopram as treatment for clinically significant agitation in Alzheimer's dementia (AD) patients. It will also investigate pharmacogenomic, genetic, and clinical predictors of response to citalopram therapy. The management of agitation is a major priority in treating patients with AD. Non-pharmacologic options have limited effectiveness. Several pharmacologic options have been explored, but findings for anticonvulsants, antipsychotics, and cholinesterase inhibitors are disappointing or associated with questionable risk-benefit ratio. Better pharmacologic options are needed. Selective serotonin reuptake inhibitors (SSRIs) show promise as a treatment for agitation in AD, based on evidence of a link between agitation and brain serotonin system abnormalities in AD patients, and on preliminary clinical data from a single-site, randomized controlled trial (RCT) in which citalopram was superior to perphenazine and placebo.

Conditions

• Alzheimer's Disease
• Agitation

Interventions

Type	Name	Description
DRUG	citalopram	target dose 30mg daily for 9 weeks
DRUG	placebo	daily for 9 weeks

Timeline

• Start date: 2009-07-01
• Primary completion: 2013-09-01
• Completion: 2013-09-01
• First posted: 2009-05-12
• Last updated: 2014-06-27
• Results posted: 2014-06-27

Locations

8 sites across 2 countries: United States, Canada