Back to results

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

Primary Purpose

Schizophrenia, Sleep

Status

Completed

Phase

Phase 4

Locations

India

Study Type

Interventional

Intervention

Olanzapine

About this trial

This is an interventional basic science trial for Schizophrenia focused on measuring Olanzapine, Schizophrenia, Polysomnography, Slow wave sleep

Eligibility Criteria

18 Years - 45 Years (Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Central Institute of Psychiatry

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Schizophrenia patients

Arm Description

The study population of 25 schizophrenia patients constituted the active arm of the study.

Outcomes

Primary Outcome Measures

Sleep EEG

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

Changes in psychopathological scores as measured by Brief Psychiatric Rating Scale (BPRS) and Positive and Negative Syndrome Scale (PANSS).

Full Information

NCT ID

NCT01149577

First Posted

June 18, 2010

Last Updated

June 22, 2010

Sponsor

Central Institute of Psychiatry, Ranchi, India

1. Study Identification

Unique Protocol Identification Number

NCT01149577

Brief Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2010

Overall Recruitment Status

Completed

Study Start Date

August 2007 (undefined)

Primary Completion Date

December 2007 (Actual)

Study Completion Date

April 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Central Institute of Psychiatry, Ranchi, India

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Schizophrenia, Sleep

Keywords

Olanzapine, Schizophrenia, Polysomnography, Slow wave sleep

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

25 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Schizophrenia patients

Arm Type

Experimental

Arm Description

The study population of 25 schizophrenia patients constituted the active arm of the study.

Intervention Type

Drug

Intervention Name(s)

Olanzapine

Intervention Description

06 weeks treatment with Olanzapine in a flexible dosage schedule.

Primary Outcome Measure Information:

Title

Sleep EEG

Description

Time Frame

06 weeks

Secondary Outcome Measure Information:

Title

Psychopathology

Description

Changes in psychopathological scores as measured by Brief Psychiatric Rating Scale (BPRS) and Positive and Negative Syndrome Scale (PANSS).

Time Frame

06 weeks

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male patients fulfilling International Classification of Diseases-10 Diagnostic Criteria for Research for schizophrenia Aged 18-50 Yrs Drug naïve or drug free (not receiving any psychotropic medication for the past 4 months) Consenting Exclusion Criteria: Any comorbid psychiatric illness Significant medical or neurological illness History of significant head injury, epilepsy Substance use in the past 4 months excluding nicotine and caffeine Presence of a primary sleep disorder

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mohammad Zia Ul Haq Katshu, DPM

Organizational Affiliation

Central Institute of Psychiatry

Official's Role

Principal Investigator

Facility Information:

Facility Name

Central Institute of Psychiatry

City

Ranchi

State/Province

Jharkhand

ZIP/Postal Code

834006

Country

India

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs