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Paroxetine in the Treatment of Chronic Primary Insomnia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00178048
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : September 15, 2005
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by:
University of Pittsburgh

Tracking Information
First Submitted Date  ICMJE September 13, 2005
First Posted Date  ICMJE September 15, 2005
Last Update Posted Date September 15, 2005
Study Start Date  ICMJE September 1998
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: September 13, 2005)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: September 13, 2005)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Paroxetine in the Treatment of Chronic Primary Insomnia
Official Title  ICMJE Paroxetine in the Treatment of Chronic Primary Insomnia: A Double-Blind, Randomized, Placebo-Controlled Study of Efficacy Over Six Weeks
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 resulting from general medical, chemical, or psychiatric conditions.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE
  • Primary Insomnia
  • Depression
Intervention  ICMJE Drug: paroxetine
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: September 13, 2005)
66
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE December 2003
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 55 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00178048
Other Study ID Numbers  ICMJE 970357
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE University of Pittsburgh
Collaborators  ICMJE GlaxoSmithKline
Investigators  ICMJE
Principal Investigator: Charles F Reynolds III, M.D. University of Pittsburgh
PRS Account University of Pittsburgh
Verification Date September 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP