An Investigation of the Sleep Architecture and Consequent Cognitive Changes in Olanzapine-Treated Depressed Patients

Exclusion Criteria

• •1. Current manic, hypomanic or mixed episode, with YMRS \> 12
• •2. Current or past diagnosis of schizophrenia and dementia
• •3. Pregnant women, or women in childbearing age, not willing to use appropriate contraception or women currently nursing
• •4. Patient on any other antipsychotic medication
• •5. Patients who, in the opinion of the investigator, pose an imminent risk of suicide or a danger to self or others
• •6. Known intolerance or lack of response to olanzapine, as judged by the investigator
• •7. Benzodiazepines and all other sleep-aids must be discontinued prior to participation in the study if they have not been at a stable dosage for the 4 weeks previous to entry into the study
• •8. No change to the current medication regime (excluding discontinuation of sleep aids and antipsychotic medications) is allowed 4 weeks prior to the first PSG reading
• •9. Administration of a depot antipsychotic injection within two dosing interval (for the depot) before randomization
• •10. Substance or alcohol dependence at enrolment or in the last three months (except for caffeine or nicotine dependence), as defined by DSM-IV criteria
• •11. Serious, unstable or inadequately treated medical illness as judged by the investigator
• •12. History of epilepsy or uncontrolled seizures
• •13. Involvement in the planning and conduct of the study
• •14. Previous enrolment in the present study
• •15. Participation in another drug trial within 4 weeks prior enrolment into this study or longer in accordance with local requirements