Quetiapine for Primary Insomnia Patients : A Randomized Controlled Trial

March 17, 2008 updated by: Khon Kaen University
Primary insomnia patients will sleep with Quetiapine not better than without Quetiapine

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

16

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Khon Kaen, Thailand, 40002
        • Srinagarind Hospital, Khon Kaen University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: B
Placebo
Drug: placebo
Experimental: A
Quetiapine
Drug: Quetiapine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Total Sleep Time
Time Frame: 3 weeks
3 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Sleep Latency Period, Sleep satisfaction
Time Frame: 3 weeks
3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Khon Kaen University

Investigators

  • Principal Investigator: Kanida Tassniyom, MD, Department of Psychiatry, Faculty of Medicine, Khon Kaen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2006

Study Completion (Actual)

August 1, 2007

Study Registration Dates

First Submitted

May 19, 2006

First Submitted That Met QC Criteria

May 19, 2006

First Posted (Estimate)

May 22, 2006

Study Record Updates

Last Update Posted (Estimate)

March 18, 2008

Last Update Submitted That Met QC Criteria

March 17, 2008

Last Verified

October 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HE490424

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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