Paroxetine in the Treatment of Chronic Primary Insomnia

• Status: Completed
• Trial end date: 2003-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Pittsburgh
• Collaborator: GlaxoSmithKline
• Treatments: Paroxetine

Criteria

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