Quetiapine for Primary Insomnia Patients : A Randomized Controlled Trial

This study has been completed.
Sponsor:
Information provided by:
Khon Kaen University
ClinicalTrials.gov Identifier:
NCT00328822
First received: May 19, 2006
Last updated: March 17, 2008
Last verified: October 2006

May 19, 2006
March 17, 2008
December 2006
Not Provided
Total Sleep Time [ Time Frame: 3 weeks ] [ Designated as safety issue: Yes ]
Sleep Latency Period, Sleep satisfaction
Complete list of historical versions of study NCT00328822 on ClinicalTrials.gov Archive Site
Sleep Latency Period, Sleep satisfaction [ Time Frame: 3 weeks ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
Not Provided
 
Quetiapine for Primary Insomnia Patients : A Randomized Controlled Trial
Quetiapine for Primary Insomnia Patients : A Randomized Controlled Trial

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

  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
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Primary Insomnia
  • Drug: Quetiapine
  • Drug: placebo
  • Experimental: A
    Quetiapine
    Intervention: Drug: Quetiapine
  • Placebo Comparator: B
    Placebo
    Intervention: Drug: placebo
Tassniyom K, Paholpak S, Tassniyom S, Kiewyoo J. Quetiapine for primary insomnia: a double blind, randomized controlled trial. J Med Assoc Thai. 2010 Jun;93(6):729-34.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
16
August 2007
Not Provided

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Thailand
 
NCT00328822
HE490424
Not Provided
Faculty of Medicine, Khon Kaen University
Khon Kaen University
Not Provided
Principal Investigator: Kanida Tassniyom, MD Department of Psychiatry, Faculty of Medicine, Khon Kaen University
Khon Kaen University
October 2006

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