Quetiapine for Primary Insomnia Patients : A Randomized Controlled Trial

NCT ID: NCT00328822

Last Updated: 2008-03-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-12-31

Study Completion Date

2007-08-31

Brief Summary

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

Detailed Description

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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

Conditions

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Primary Insomnia

Keywords

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Primary insomnia Quetiapine Randomized controlled trial Double blind

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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A

Quetiapine

Group Type EXPERIMENTAL

Quetiapine

Intervention Type DRUG

B

Placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Interventions

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Quetiapine

Intervention Type DRUG

placebo

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Khon Kaen University

OTHER

Sponsor Role lead

Responsible Party

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Khon Kaen University

Principal Investigators

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Kanida Tassniyom, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Psychiatry, Faculty of Medicine, Khon Kaen University

Locations

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Srinagarind Hospital, Khon Kaen University

Khon Kaen, Changwat Khon Kaen, Thailand

Site Status

Countries

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Thailand

References

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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.

Reference Type DERIVED
PMID: 20572379 (View on PubMed)

Other Identifiers

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HE490424

Identifier Type: -

Identifier Source: org_study_id