Quetiapine for Primary Insomnia Patients : A Randomized Controlled Trial

Khon Kaen University

Status: Completed

Conditions: Primary Insomnia

Treatments: Drug: Quetiapine; Drug: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT00328822

HE490424

Details and patient eligibility

About

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

Full 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

Enrollment: 16 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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16 participants in 2 patient groups, including a placebo group

A

Experimental group

Description:

Quetiapine

Treatment:

Drug: Quetiapine

B

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: placebo