Paroxetine in the Treatment of Chronic Primary Insomnia

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

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.

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.

Intervention(s) in this Clinical Trial

• Drug: paroxetine

Primary 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 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

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 Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 55 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: University of Pittsburgh Other

Overall Clinical Trial Officials and Contacts

Charles F Reynolds III, M.D. Principal Investigator University of Pittsburgh  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00178048

Study ID Number: 970357

ClinicalTrials.gov Identifier: NCT00178048

Health Authority: United States: Institutional Review Board

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