Depression Clinical Trial
Official title:
Paroxetine in the Treatment of Chronic Primary Insomnia: A Double-Blind, Randomized, Placebo-Controlled Study of Efficacy Over Six Weeks
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.
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.
;
Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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