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

Study Overview
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Brief Summary
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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
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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
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Schizophrenia, Sleep

Intervention / Treatment
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* Drug: Olanzapine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male patients fulfilling International Classification of Diseases-10 Diagnostic Criteria for Research for schizophrenia Aged 18-50 Yrs Drug naïve or drug free (not receiving any psychotropic medication for the past 4 months) Consenting Exclusion Criteria: Any comorbid psychiatric illness Significant medical or neurological illness History of significant head injury, epilepsy Substance use in the past 4 months excluding nicotine and caffeine Presence of a primary sleep disorder

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Schizophrenia patients<br>The study population of 25 schizophrenia patients constituted the active arm of the study. | Drug: Olanzapine<br>* 06 weeks treatment with Olanzapine in a flexible dosage schedule.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep EEG | 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. | 06 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Psychopathology | Changes in psychopathological scores as measured by Brief Psychiatric Rating Scale (BPRS) and Positive and Negative Syndrome Scale (PANSS). | 06 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Olanzapine, Schizophrenia, Polysomnography, Slow wave sleep