Schizophrenia, Sleep
Conditions
Keywords
Olanzapine, Schizophrenia, Polysomnography, Slow wave sleep
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.
Interventions
DRUGOlanzapine
06 weeks treatment with Olanzapine in a flexible dosage schedule.
Sponsors
Central Institute of Psychiatry, Ranchi, India
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sleep EEG | 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
| Measure | Time frame | Description |
|---|---|---|
| Psychopathology | 06 weeks | Changes in psychopathological scores as measured by Brief Psychiatric Rating Scale (BPRS) and Positive and Negative Syndrome Scale (PANSS). |
Countries
India
Outcome results
None listed