Quetiapine for Primary Insomnia Patients : A Randomized Controlled Trial

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

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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

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