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Quetiapine for Primary Insomnia Patients : A Randomized Controlled Trial

This study has been completed.
Information provided by:
Khon Kaen University Identifier:
First received: May 19, 2006
Last updated: March 17, 2008
Last verified: October 2006
Primary insomnia patients will sleep with Quetiapine not better than without Quetiapine

Condition Intervention
Primary Insomnia Drug: Quetiapine Drug: placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Quetiapine for Primary Insomnia Patients : A Randomized Controlled Trial

Resource links provided by NLM:

Further study details as provided by Khon Kaen University:

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

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

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

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

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
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Please refer to this study by its identifier: NCT00328822

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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Faculty of Medicine, Khon Kaen University Identifier: NCT00328822     History of Changes
Other Study ID Numbers: HE490424
Study First Received: May 19, 2006
Last Updated: March 17, 2008

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

Additional relevant MeSH terms:
Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders
Quetiapine Fumarate
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs processed this record on September 21, 2017