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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01149577
First Posted: June 23, 2010
Last Update Posted: June 23, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Central Institute of Psychiatry, Ranchi, India
  Purpose
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: None (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.
  Eligibility

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

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01149577


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

Responsible Party: S Haque Nizamie, Central Institute of Psychiatry
ClinicalTrials.gov Identifier: NCT01149577     History of Changes
Other Study ID Numbers: SCHOLZ0003
First Submitted: June 18, 2010
First Posted: June 23, 2010
Last Update Posted: June 23, 2010
Last Verified: June 2010

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

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Olanzapine
Antiemetics
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


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