Paroxetine in the Treatment of Chronic Primary Insomnia

Sponsor

University of Pittsburgh (Other)

Overall Status

Completed

CT.gov ID

NCT00178048

Collaborator

GlaxoSmithKline (Industry)

Enrollment

Locations

Duration (Months)

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Primary Insomnia Depression	Drug: paroxetine	Phase 4

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 Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Masking:

Double

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Sep 1, 1998

Study Completion Date :

Dec 1, 2003

Outcome Measures

Primary Outcome Measures

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

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

55 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania	United States	15213
2	University of Pittsubrgh Medical Center	Pittsburgh	Pennsylvania	United States	15213