Status:
COMPLETED
Paroxetine in the Treatment of Chronic Primary Insomnia
Lead Sponsor:
University of Pittsburgh
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
Primary Insomnia
Depression
Eligibility:
All Genders
55+ years
Phase:
PHASE4
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 resul...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 1998
Trial Type :
INTERVENTIONAL
End Date :
December 1 2003
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT00178048
Start Date
September 1 1998
End Date
December 1 2003
Last Update
September 15 2005
Active Locations (2)
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1
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
2
University of Pittsubrgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213