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

Overview

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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Basic Science
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2007

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.

Interventions

  • Drug: Olanzapine
    • 06 weeks treatment with Olanzapine in a flexible dosage schedule.

Arms, Groups and Cohorts

  • Experimental: Schizophrenia patients
    • The study population of 25 schizophrenia patients constituted the active arm of the study.

Clinical Trial Outcome Measures

Primary Measures

  • Sleep EEG
    • Time Frame: 06 weeks
    • 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.

Secondary Measures

  • Psychopathology
    • Time Frame: 06 weeks
    • Changes in psychopathological scores as measured by Brief Psychiatric Rating Scale (BPRS) and Positive and Negative Syndrome Scale (PANSS).

Participating in This Clinical Trial

Inclusion Criteria

1. Male patients fulfilling International Classification of Diseases-10 Diagnostic Criteria for Research for schizophrenia 2. Aged 18-50 Yrs 3. Drug naïve or drug free (not receiving any psychotropic medication for the past 4 months) 4. Consenting Exclusion Criteria:

1. Any comorbid psychiatric illness 2. Significant medical or neurological illness 3. History of significant head injury, epilepsy 4. Substance use in the past 4 months excluding nicotine and caffeine 5. Presence of a primary sleep disorder

Gender Eligibility: Male

Minimum Age: 18 Years

Maximum Age: 45 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Central Institute of Psychiatry, Ranchi, India
  • Provider of Information About this Clinical Study
    • S Haque Nizamie, Central Institute of Psychiatry
  • Overall Official(s)
    • Mohammad Zia Ul Haq Katshu, DPM, Principal Investigator, Central Institute of Psychiatry

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