Quetiapine for Primary Insomnia Patients : A Randomized Controlled Trial

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00328822

Enrollment

Registered

2006-05-22

Start date

2006-12-31

Completion date

2007-08-31

Last updated

2008-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Insomnia

Keywords

Primary insomnia, Quetiapine, Randomized controlled trial, Double blind

Brief summary

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

Detailed 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

Interventions

DRUGQuetiapine

DRUGplacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame
Total Sleep Time	3 weeks

Secondary

Measure	Time frame
Sleep Latency Period, Sleep satisfaction	3 weeks

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026