NCT01149577

Effect of Olanzapine on Sleep Electroencephalogram (EEG) in Schizophrenia Patients

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Central Institute of Psychiatry, Ranchi, India · Academic / Other
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

Acute and sub-chronic administration of olanzapine has shown a favourable effect on the sleep disturbances in previously medicated schizophrenia patients with predominantly negative symptoms. The present study will be carried out to clarify the effect of olanzapine on polysomnographic profiles of schizophrenia patients in an acute phase of illness after controlling for the drug effects.

Detailed description

Twenty schizophrenia patients (11 drug naïve and 9 drug free) will be studied over a period of six weeks of olanzapine treatment. Patients will be assessed at the baseline on BPRS, PANSS, CDSS and UKU side effect rating scales and a baseline 40 channels polysomnography will be done. After the initial assessment, patients will put on olanzapine treatment, in flexible dosages based on clinical response, for a period of six weeks when a final assessment on clinical rating scales and polysomnography will be done. The sleep data will be scored manually for staging based on Rechtschaffen and Kales criteria.

Conditions

• Schizophrenia
• Sleep

Interventions

Type	Name	Description
DRUG	Olanzapine	06 weeks treatment with Olanzapine in a flexible dosage schedule.

Timeline

• Start date: 2007-08-01
• Primary completion: 2007-12-01
• Completion: 2009-04-01
• First posted: 2010-06-23
• Last updated: 2010-06-23

Locations

1 site across 1 country: India