Schizophrenia Clinical Trial
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.
Status | Completed |
Enrollment | 25 |
Est. completion date | April 2009 |
Est. primary completion date | December 2007 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years to 45 Years |
Eligibility |
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 |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
Country | Name | City | State |
---|---|---|---|
India | Central Institute of Psychiatry | Ranchi | Jharkhand |
Lead Sponsor | Collaborator |
---|---|
Central Institute of Psychiatry, Ranchi, India |
India,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
Secondary | Psychopathology | Changes in psychopathological scores as measured by Brief Psychiatric Rating Scale (BPRS) and Positive and Negative Syndrome Scale (PANSS). | 06 weeks | No |
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