Quetiapine for Primary Insomnia Patients : A Randomized Controlled Trial

Verified by: Khon Kaen University, October 2006
First Received: May 19, 2006 | Last Updated: March 17, 2008 | Phase: N/A | Start Date: December 2006
Overall Status: Completed | Estimated Enrollment: 16
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Primary insomnia patients will sleep with Quetiapine not better than without...

Brief Summary

Official Title: “Quetiapine for Primary Insomnia Patients : A Randomized Controlled Trial”

Primary insomnia patients will sleep with Quetiapine not better than without Quetiapine

  • Study Type: Interventional
  • Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Detailed Clinical Trial Description

1. Primary insomnia will be diagnosed according to DSM-IV-TR

2. After consenting, cases will be divided (double blind randomization)in to two arms 2.1 sleep hygiene with placebo group 2.2 sleep hygiene with Quetiapine group

3. outcome measurement: sleep diary, sleep satisfaction visual analog scale and sleep satisfaction likert scale

4. statistical method: dependent T test

Intervention(s) in this Clinical Trial

  • Drug: Quetiapine
  • Drug: placebo

Arms, Groups and Cohorts in this Clinical Trial

  • Experimental: A
    • Quetiapine
  • Placebo Comparator: B
    • Placebo

Outcome Measures for this Clinical Trial

Primary Measures

  • Total Sleep Time
    • Time Frame: 3 weeks
      Safety Issue?: Yes

Secondary Measures

  • Sleep Latency Period, Sleep satisfaction
    • Time Frame: 3 weeks
      Safety Issue?: Yes

Criteria for Participation in this Clinical Trial

Inclusion Criteria:

  • Primary insomnia Patients by DSM-IV-TR criteria
  • cases enrolled: age 18-65 educated

Exclusion Criteria:

  • Currently receiving Quetiapine or other hypnotic drugs
  • Liver disease
  • Patients with heart Dz, Hypertension, thyroid disease
  • History of epilepsy or febrile convulsion
  • pregnant
  • cognitive impairments
  • History of Orthostatic Hypotension
  • Patient with other Psychiatric conditions or Drug dependence

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Clinical Trial Investigator Information

Lead Investigator: Khon Kaen University Other

Overall Clinical Trial Officials and Contacts

Kanida Tassniyom, MD Principal Investigator Department of Psychiatry, Faculty of Medicine, Khon Kaen University  

Additional Information

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00328822

Study ID Number: HE490424

ClinicalTrials.gov Identifier: NCT00328822

Health Authority: Thailand: Ethical Committee

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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00328822