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NCT Number: NCT01149577

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

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.

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Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders Sleep

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Central Institute of Psychiatry

Ranchi, Jharkhand, 834006, India

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Olanzapine

Drug

06 weeks treatment with Olanzapine in a flexible dosage schedule.

Primary outcomes

  1. 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 outcomes

  1. Psychopathology

    Time frame: 06 weeks

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

Sponsors and collaborators

Lead sponsor

Central Institute of Psychiatry, Ranchi, India

Other

Registry information

Important dates

Study start
2007
Primary completion
2007
Study completion
2009
First posted
Jun 23, 2010
Registry last updated
Jun 23, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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