Paroxetine in the Treatment of Chronic Primary Insomnia

Phase 4

Completed

• Conditions: Primary Insomnia; Depression

• Registration Number: NCT00178048
• Lead Sponsor: University of Pittsburgh

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.

Study Timeline

• Study Start: 1998-09
• Study Completion: 2003-12
• Status Verified: 2005-09
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Last Update Submitted: 2005-09-13
• Study First Posted: 2005-09-15
• Last Update Posted: 2005-09-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (2)

University of Pittsburgh Medical Center; 🇺🇸 Pittsburgh, Pennsylvania, United States

University of Pittsubrgh Medical Center; 🇺🇸 Pittsburgh, Pennsylvania, United States