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

June 22, 2010 updated by: Central Institute of Psychiatry, Ranchi, India
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 Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Jharkhand
      • Ranchi, Jharkhand, India, 834006
        • Central Institute of Psychiatry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
06 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central Institute of Psychiatry, Ranchi, India

Investigators

  • Principal Investigator: Mohammad Zia Ul Haq Katshu, DPM, Central Institute of Psychiatry

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2007

Primary Completion (Actual)

December 1, 2007

Study Completion (Actual)

April 1, 2009

Study Registration Dates

First Submitted

June 18, 2010

First Submitted That Met QC Criteria

June 22, 2010

First Posted (Estimate)

June 23, 2010

Study Record Updates

Last Update Posted (Estimate)

June 23, 2010

Last Update Submitted That Met QC Criteria

June 22, 2010

Last Verified

June 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SCHOLZ0003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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