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Quetiapine for Primary Insomnia Patients : A Randomized Controlled Trial
This study has been completed.
Sponsored by: Khon Kaen University
Information provided by: Khon Kaen University
ClinicalTrials.gov Identifier: NCT00328822
  Purpose

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


Condition Intervention
Primary Insomnia
 Drug: Quetiapine
Drug: placebo

Drug Information available for: Quetiapine Quetiapine fumarate
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Official Title: Quetiapine for Primary Insomnia Patients : A Randomized Controlled Trial

Further study details as provided by Khon Kaen University:

Primary Outcome Measures:
  • Total Sleep Time [ Time Frame: 3 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Sleep Latency Period, Sleep satisfaction [ Time Frame: 3 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 16
Study Start Date: December 2006
Study Completion Date: August 2007
Arms Assigned Interventions
A: Experimental
Quetiapine
Drug: Quetiapine
B: Placebo Comparator
Placebo
Drug: placebo

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
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Responsible Party: Khon Kaen University ( Faculty of Medicine )
Study ID Numbers: HE490424
Study First Received: May 19, 2006
Last Updated: March 17, 2008
ClinicalTrials.gov Identifier: NCT00328822  
Health Authority: Thailand: Ethical Committee

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

Study placed in the following topic categories:
Sleep Initiation and Maintenance Disorders
Quetiapine
Mental Disorders
 Dyssomnias
Sleep Disorders
Sleep Disorders, Intrinsic

Additional relevant MeSH terms:
Tranquilizing Agents
Therapeutic Uses
Physiological Effects of Drugs
Nervous System Diseases
Psychotropic Drugs
 Central Nervous System Depressants
Antipsychotic Agents
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009



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