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Quetiapine for Primary Insomnia Patients : A Randomized Controlled Trial

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ClinicalTrials.gov Identifier: NCT00328822
Recruitment Status : Completed
First Posted : May 22, 2006
Last Update Posted : March 18, 2008
Sponsor:
Information provided by:
Khon Kaen University

Brief Summary:
Primary insomnia patients will sleep with Quetiapine not better than without Quetiapine

Condition or disease Intervention/treatment Phase
Primary Insomnia Drug: Quetiapine Drug: placebo Not Applicable

Detailed 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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Quetiapine for Primary Insomnia Patients : A Randomized Controlled Trial
Study Start Date : December 2006
Actual Study Completion Date : August 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: A
Quetiapine
Drug: Quetiapine
Placebo Comparator: B
Placebo
Drug: placebo



Primary Outcome Measures :
  1. Total Sleep Time [ Time Frame: 3 weeks ]

Secondary Outcome Measures :
  1. Sleep Latency Period, Sleep satisfaction [ Time Frame: 3 weeks ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00328822


Locations
Thailand
Srinagarind Hospital, Khon Kaen University
Khon Kaen, Thailand, 40002
Sponsors and Collaborators
Khon Kaen University
Investigators
Principal Investigator: Kanida Tassniyom, MD Department of Psychiatry, Faculty of Medicine, Khon Kaen University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Faculty of Medicine, Khon Kaen University
ClinicalTrials.gov Identifier: NCT00328822     History of Changes
Other Study ID Numbers: HE490424
First Posted: May 22, 2006    Key Record Dates
Last Update Posted: March 18, 2008
Last Verified: October 2006

Keywords provided by Khon Kaen University:
Primary insomnia
Quetiapine
Randomized controlled trial
Double blind

Additional relevant MeSH terms:
Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders
Quetiapine Fumarate
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs