NCT00178048

Paroxetine in the Treatment of Chronic Primary Insomnia

Paroxetine in the Treatment of Chronic Primary Insomnia: A Double-Blind, Randomized, Placebo-Controlled Study of Efficacy Over Six Weeks

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 66 (planned)
• Sponsor: University of Pittsburgh · Academic / Other
• Sex: All
• Age: 55 Years
• Healthy volunteers: Not accepted

Summary

The goal of the study is to examine the role of paroxetine, an antidepressant medication, in the acute and continuation treatment of insomnia. Primary insomnia is a type of insomnia not directly resulting from general medical, chemical, or psychiatric conditions.

Detailed description

The primary aim of this study is to demonstrate the role of paroxetine in the acute treatment of chronic primary insomnia. Paroxetine taken on a nightly basis in combination with sleep hygiene therapy will produce a greater number of diagnostic responders in acute treatment, compared to a placebo and sleep hygiene control condition, in a randomized, double-blinded, six-week acute treatment trial. EEG sleep, sleep quality, and daytime well-being, and daytime functioning will also show superior treatment effects during acute treatment with paroxetine plus sleep hygiene, as compared with the placebo control condition. A total of 66 patients with primary insomnia, as defined by DSM-IV criteria, will be randomized (1:1) to receive paroxetine plus sleep hygiene therapy (P+SH-a) or placebo plus sleep hygiene therapy (PL+SH-a) in weekly acute treatment sessions evolving over a six-week interval in a double-blinded, parallel group design.

Conditions

• Primary Insomnia
• Depression

Interventions

Type	Name	Description
DRUG	paroxetine

Timeline

• Start date: 1998-09-01
• Completion: 2003-12-01
• First posted: 2005-09-15
• Last updated: 2005-09-15

Locations

2 sites across 1 country: United States