Quetiapine for Primary Insomnia Patients : A Randomized Controlled Trial

Not Applicable

Completed

• Conditions: Primary Insomnia
• Interventions: Drug: placebo; Drug: Quetiapine

• Registration Number: NCT00328822
• Lead Sponsor: Khon Kaen University

Brief Summary

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

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

Study Timeline

• Study First Submitted: 2006-05-19
• Study First Submitted QC: 2006-05-19
• Study First Posted: 2006-05-22
• Status Verified: 2006-10
• Study Start: 2006-12
• Study Completion: 2007-08
• Last Update Submitted: 2008-03-17
• Last Update Posted: 2008-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B	placebo	Placebo
A	Quetiapine	Quetiapine

Primary Outcome Measures

Name	Time	Method
Total Sleep Time	3 weeks

Secondary Outcome Measures

Name	Time	Method
Sleep Latency Period, Sleep satisfaction	3 weeks

Trial Locations

Locations (1)

Srinagarind Hospital, Khon Kaen University; 🇹🇭 Khon Kaen, Thailand