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

This study has been completed.
Sponsor:
Information provided by:
Central Institute of Psychiatry, Ranchi, India
ClinicalTrials.gov Identifier:
NCT01149577
First received: June 18, 2010
Last updated: June 22, 2010
Last verified: June 2010
History of Changes
  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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science

Resource links provided by NLM:

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

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

Primary Outcome Measures:
  • Sleep EEG [ Time Frame: 06 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years to 45 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: S Haque Nizamie, Central Institute of Psychiatry
ClinicalTrials.gov Identifier: NCT01149577     History of Changes
Other Study ID Numbers: SCHOLZ0003
Study First Received: June 18, 2010
Last Updated: June 22, 2010
Health Authority: India: Institutional Review Board

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

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Olanzapine
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
 Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents

ClinicalTrials.gov processed this record on October 17, 2012