Paroxetine in the Treatment of Chronic Primary Insomnia

This study has been completed.

Sponsor:

Collaborator:

GlaxoSmithKline

Information provided by:

University of Pittsburgh

ClinicalTrials.gov Identifier:

NCT00178048

First received: September 13, 2005

Last updated: NA

Last verified: September 2005

History: No changes posted

Tracking Information

First Received Date ^ICMJE

September 13, 2005

Last Updated Date

September 13, 2005

Start Date ^ICMJE

September 1998

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Paroxetine in the Treatment of Chronic Primary Insomnia

Official Title ^ICMJE

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

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 Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

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

Condition ^ICMJE

Primary Insomnia
Depression

Intervention ^ICMJE

Drug: paroxetine

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

December 2003

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

55 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00178048

Other Study ID Numbers ^ICMJE

970357

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

University of Pittsburgh

Collaborators ^ICMJE

GlaxoSmithKline

Investigators ^ICMJE

Principal Investigator:

Charles F Reynolds III, M.D.

University of Pittsburgh

Information Provided By

University of Pittsburgh

Verification Date

September 2005

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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