Paroxetine in the Treatment of Chronic Primary Insomnia

Completed · Phase 4

Conditions studied: Primary Insomnia, Depression

In brief

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.

Key facts

Study ID

NCT00178048

Run by

University of Pittsburgh

People needed

66

Starts

1998-09-01

Expected to finish

2003-12-01

Last updated by the study team

2005-09-15

Who can join

Age: 55 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
• University of Pittsubrgh Medical Center — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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