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OpenTrials
Completed

NCT Number: NCT00328822

Quetiapine for Primary Insomnia Patients : A Randomized Controlled Trial

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

Completed

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Key information

Conditions

Primary Insomnia Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Srinagarind Hospital, Khon Kaen University

Khon Kaen, Changwat Khon Kaen, 40002, Thailand

About this study

  • 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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Quetiapine

Drug

Placebo

Drug

Primary outcomes

  1. Total Sleep Time

    Time frame: 3 weeks

Secondary outcomes

  1. Sleep Latency Period, Sleep satisfaction

    Time frame: 3 weeks

Sponsors and collaborators

Lead sponsor

Khon Kaen University

Other

Registry information

Important dates

Study start
2006
Study completion
2007
First posted
May 22, 2006
Registry last updated
Mar 18, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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