Paroxetine in the Treatment of Chronic Primary Insomnia

Study Overview
=================
Brief 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.

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

Conditions
-----------------
Primary Insomnia, Depression

Intervention / Treatment
-----------------
* Drug: paroxetine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 55 or older Diagnosis of chronic primary insomnia Score of 8 or higher on the Pittsburgh Sleep Quality Index free of all antidepressants and benzodiazepine for two weeks Exclusion Criteria: lifetime diagnosis of any psychotic disorder,or bipolar disorder. DSM-IV diagnosis of dysthymia or generalized anxiety disorder Diagnosis of major depression within the past 6 months Alcohol or drug abuse within the past 6 months Contraindication to SSRI therapy History of seizure disorder Baseline apnea/hypopnea index score greater than 15 Hyponatremia

Ages Eligible for Study
-----------------
Minimum Age: 55 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: paroxetine|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Paroxetine in combination with sleep hygiene therapy will produce a greater number of responders in acute treatment, compared to a placebo and sleep hygiene condition, in a randomized, double-blinded, six-week acute trial |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Polysomnographic Sleep measures |  |  | 
| Pittsburgh Sleep Quality Index and Sleep Diary |  |  | 
| Daytime well being on the Profile of Mood States |  |  | 
| Daytime functioning on the Sickness Impact Profile, Medical Outcomes Study (SF-36), and UKU |  |  | 
| Stress measures: Schedule of Recent Events, Perceived Stress Scale, Impact of Life Events Scale, Ways of Coping Inventory, Multidimensional Fatigue Inventory, and Brief Symptom Inventory |  |  | 
| Psychophysiological arousal and mood measures collected at each sleep study: the Pres-Sleep Arousal Scale, Spielman Insomnia Symptom Questionnaire, Pittsburgh Insomnia Rating Scale, and the Pre-Sleep Experience Questionnaire. |  |  | 
| SCID |  |  | 
| Sleep Hygiene Awareness and Practices Scale |  |  | 
| Diagnostic Response: Clinical Global Impressions Scale |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
primary insomnia, insomnia, depression, late life, elderly, sleep disorders