Paroxetine in the Treatment of Chronic Primary Insomnia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

1998-09-30

Study Completion Date

2003-12-31

Brief Summary

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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

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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.

Conditions

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Primary Insomnia Depression

Keywords

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primary insomnia insomnia depression late life elderly sleep disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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paroxetine

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Charles F Reynolds III, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

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University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Site Status

University of Pittsubrgh Medical Center