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
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 |
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.
Status | Completed |
Enrollment | 66 |
Est. completion date | December 2003 |
Est. primary completion date | |
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 |
Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania |
United States | University of Pittsubrgh Medical Center | Pittsburgh | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
University of Pittsburgh | GlaxoSmithKline |
United States,
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 |
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