Quetiapine for Primary Insomnia Patients : A Randomized Controlled Trial

Khon Kaen University16 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Primary Insomnia

Interventions

QuetiapineDRUG

placeboDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Srinagarind Hospital, Khon Kaen University

Khon Kaen, Changwat Khon Kaen, Thailand

Outcomes

Primary Outcomes

Total Sleep Time

Time frame: 3 weeks

Secondary Outcomes

Sleep Latency Period, Sleep satisfaction

Time frame: 3 weeks

Data from ClinicalTrials.gov

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