NCT01149577

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for phase_4 schizophrenia

Timeline
Completed

Started Aug 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2007

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

June 18, 2010

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 23, 2010

Completed
Last Updated

June 23, 2010

Status Verified

June 1, 2010

Enrollment Period

4 months

First QC Date

June 18, 2010

Last Update Submit

June 22, 2010

Conditions

SchizophreniaSleep

Keywords

OlanzapineSchizophreniaPolysomnographySlow wave sleep

Outcome Measures

Primary Outcomes (1)

  • 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.

    06 weeks

Secondary Outcomes (1)

  • Psychopathology

    06 weeks

Study Arms (1)

Schizophrenia patients

EXPERIMENTAL

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

Drug: Olanzapine

Interventions

OlanzapineDRUG

06 weeks treatment with Olanzapine in a flexible dosage schedule.

Schizophrenia patients

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Central Institute of Psychiatry

Ranchi, Jharkhand, 834006, India

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

Olanzapine

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

BenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Mohammad Zia Ul Haq Katshu, DPM

    Central Institute of Psychiatry

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 18, 2010

First Posted

June 23, 2010

Study Start

August 1, 2007

Primary Completion

December 1, 2007

Study Completion

April 1, 2009

Last Updated

June 23, 2010

Record last verified: 2010-06

Locations

IN(1)