Paroxetine in the Treatment of Chronic Primary Insomnia

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00178048
• Other study ID #: 970357
• Status: Completed
• Phase: Phase 4
• First received: September 13, 2005
• Last updated: September 13, 2005
• Start date: September 1998
• Est. completion date: December 2003

Study information

• Verified date: September 2005
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: December 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 55 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Depression
• Primary Insomnia
• Sleep Initiation and Maintenance Disorders

Intervention

Drug:
• paroxetine

Locations

Country	Name	City	State
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	University of Pittsubrgh Medical Center	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Polysomnographic Sleep measures
Secondary	Pittsburgh Sleep Quality Index and Sleep Diary
Secondary	Daytime well being on the Profile of Mood States
Secondary	Daytime functioning on the Sickness Impact Profile, Medical Outcomes Study (SF-36), and UKU
Secondary	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
Secondary	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.
Secondary	SCID
Secondary	Sleep Hygiene Awareness and Practices Scale
Secondary	Diagnostic Response: Clinical Global Impressions Scale