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NCT00328822 Clinical Trial

Quetiapine for Primary Insomnia Patients : A Randomized Controlled Trial

Primary Insomnia Clinical Trial

Official title:
Quetiapine for Primary Insomnia Patients : A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00328822
Other study ID # HE490424
Secondary ID
Status Completed
Phase N/A
First received May 19, 2006
Last updated March 17, 2008
Start date December 2006
Est. completion date August 2007

Study information
Verified date October 2006
Source Khon Kaen University
Contact n/a
Is FDA regulated No
Health authority Thailand: Ethical Committee
Study type Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility
Status Completed
Enrollment 16
Est. completion date August 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility 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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Quetiapine

• placebo

Locations
Country Name City State
Thailand Srinagarind Hospital, Khon Kaen University Khon Kaen

Sponsors (1)
Lead Sponsor Collaborator
Khon Kaen University

Country where clinical trial is conducted

Thailand, 

Outcome
Type Measure Description Time frame Safety issue
Primary Total Sleep Time 3 weeks Yes
Secondary Sleep Latency Period, Sleep satisfaction 3 weeks Yes
See also
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