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

This study has been completed.
Information provided by:
Central Institute of Psychiatry, Ranchi, India Identifier:
First received: June 18, 2010
Last updated: June 22, 2010
Last verified: June 2010
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.

Condition Intervention Phase
Schizophrenia Sleep Drug: Olanzapine Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science

Resource links provided by NLM:

Further study details as provided by Central Institute of Psychiatry, Ranchi, India:

Primary Outcome 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 Outcome 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).

Enrollment: 25
Study Start Date: August 2007
Study Completion Date: April 2009
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT01149577

Central Institute of Psychiatry
Ranchi, Jharkhand, India, 834006
Sponsors and Collaborators
Central Institute of Psychiatry, Ranchi, India
Principal Investigator: Mohammad Zia Ul Haq Katshu, DPM Central Institute of Psychiatry
  More Information

Responsible Party: S Haque Nizamie, Central Institute of Psychiatry Identifier: NCT01149577     History of Changes
Other Study ID Numbers: SCHOLZ0003
Study First Received: June 18, 2010
Last Updated: June 22, 2010

Keywords provided by Central Institute of Psychiatry, Ranchi, India:
Slow wave sleep

Additional relevant MeSH terms:
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents processed this record on July 19, 2017