Quetiapine for Primary Insomnia Patients : A Randomized Controlled Trial
Primary Purpose
Primary Insomnia
Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Quetiapine
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Primary Insomnia focused on measuring Primary insomnia, Quetiapine, Randomized controlled trial, Double blind
Eligibility 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
Sites / Locations
- Srinagarind Hospital, Khon Kaen University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
A
B
Arm Description
Quetiapine
Placebo
Outcomes
Primary Outcome Measures
Total Sleep Time
Secondary Outcome Measures
Sleep Latency Period, Sleep satisfaction
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00328822
Brief Title
Quetiapine for Primary Insomnia Patients : A Randomized Controlled Trial
Official Title
Quetiapine for Primary Insomnia Patients : A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2006
Overall Recruitment Status
Completed
Study Start Date
December 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Khon Kaen University
4. Oversight
5. Study Description
Brief Summary
Primary insomnia patients will sleep with Quetiapine not better than without Quetiapine
Detailed Description
Primary insomnia will be diagnosed according to DSM-IV-TR
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
outcome measurement: sleep diary, sleep satisfaction visual analog scale and sleep satisfaction likert scale
statistical method: dependent T test
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Insomnia
Keywords
Primary insomnia, Quetiapine, Randomized controlled trial, Double blind
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
16 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Arm Description
Quetiapine
Arm Title
B
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Quetiapine
Intervention Type
Drug
Intervention Name(s)
placebo
Primary Outcome Measure Information:
Title
Total Sleep Time
Time Frame
3 weeks
Secondary Outcome Measure Information:
Title
Sleep Latency Period, Sleep satisfaction
Time Frame
3 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kanida Tassniyom, MD
Organizational Affiliation
Department of Psychiatry, Faculty of Medicine, Khon Kaen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Srinagarind Hospital, Khon Kaen University
City
Khon Kaen
ZIP/Postal Code
40002
Country
Thailand
12. IPD Sharing Statement
Citations:
PubMed Identifier
20572379
Citation
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.
Results Reference
derived
Learn more about this trial
Quetiapine for Primary Insomnia Patients : A Randomized Controlled Trial
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