Effect of Olanzapine on Sleep Electroencephalogram (EEG) in Schizophrenia Patients
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.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
- Sleep EEG [ Time Frame: 06 weeks ] [ Designated as safety issue: No ]Changes in Sleep EEG parameters like Total sleep time, total sleep period, sleep efficiency, sleep latency, stage shifts, stage 1 shifts, stage 1 parameters, stage 2 parameters, stage 3 parameters, stage 4 parameters, rapid eye movement (REM) parameters.
- Psychopathology [ Time Frame: 06 weeks ] [ Designated as safety issue: No ]Changes in psychopathological scores as measured by Brief Psychiatric Rating Scale (BPRS) and Positive and Negative Syndrome Scale (PANSS).
|Study Start Date:||August 2007|
|Study Completion Date:||April 2009|
|Primary Completion Date:||December 2007 (Final data collection date for primary outcome measure)|
Experimental: Schizophrenia patients
The study population of 25 schizophrenia patients constituted the active arm of the study.
06 weeks treatment with Olanzapine in a flexible dosage schedule.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01149577
|Central Institute of Psychiatry|
|Ranchi, Jharkhand, India, 834006|
|Principal Investigator:||Mohammad Zia Ul Haq Katshu, DPM||Central Institute of Psychiatry|