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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
Khon Kaen University
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
May 19, 2006
Last Updated
March 17, 2008
Sponsor
Khon Kaen University
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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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