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Paroxetine in the Treatment of Chronic Primary Insomnia

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by:
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00178048
First received: September 13, 2005
Last updated: NA
Last verified: September 2005
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Primary Insomnia
Depression
Drug: paroxetine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Paroxetine in the Treatment of Chronic Primary Insomnia: A Double-Blind, Randomized, Placebo-Controlled Study of Efficacy Over Six Weeks

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome 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 Outcome 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

Estimated Enrollment: 66
Study Start Date: September 1998
Estimated Study Completion Date: December 2003
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 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.

  Eligibility

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00178048

Locations
United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
University of Pittsubrgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
GlaxoSmithKline
Investigators
Principal Investigator: Charles F Reynolds III, M.D. University of Pittsburgh
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00178048     History of Changes
Other Study ID Numbers: 970357
Study First Received: September 13, 2005
Last Updated: September 13, 2005
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
primary insomnia
insomnia
depression
late life
elderly
sleep disorders

Additional relevant MeSH terms:
Depression
Depressive Disorder
Sleep Initiation and Maintenance Disorders
Behavioral Symptoms
Dyssomnias
Mental Disorders
Mood Disorders
Nervous System Diseases
Sleep Disorders
Sleep Disorders, Intrinsic
Paroxetine
Antidepressive Agents
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Uptake Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014