An Investigation of Sleep Architecture in Ziprasidone-Treated Bipolar Depression

• Drug: ziprasidone hydrochloride
  oral capsules, from 40-80 mg BID, for one month with the option to continue the medication after the study has been completed
  Other Name: Zeldox
• Drug: placebo
  placebo comparator, oral capsules, BID, for one month

• Experimental: Ziprasidone
  Intervention: Drug: ziprasidone hydrochloride
• Placebo Comparator: Sugar pill
  Intervention: Drug: placebo

• Cohrs S, Meier A, Neumann AC, Jordan W, Rüther E, Rodenbeck A. Improved sleep continuity and increased slow wave sleep and REM latency during ziprasidone treatment: a randomized, controlled, crossover trial of 12 healthy male subjects. J Clin Psychiatry. 2005 Aug;66(8):989-96.
• Sharpley AL, Cowen PJ. Effect of pharmacologic treatments on the sleep of depressed patients. Biol Psychiatry. 1995 Jan 15;37(2):85-98. Review.

Inclusion Criteria:

• A diagnosis of Bipolar Disorder Type 1,2 or NOS by Diagnostic and Statistical Manual of Mental Disorders- Fourth Edition (DSM-IV).
• Current depressive episode with a HAMD-17 of >16.
• Males or Females over age 18yrs.
• Inpatients or outpatients.
• Female patients of childbearing potential must be using a reliable method of contraception and have a negative urine human chorionic gonadotropin (HCG) test at enrolment.
• Able to understand and comply with the requirements of the study.
• Provision of written informed consent.

Exclusion Criteria:

• Current Manic, Hypomanic or Mixed episode, with YMRS > 12.
• Current or past diagnosis of Schizophrenia and Dementia.
• Pregnant women, or women in childbearing age, not willing to use appropriate contraception or women currently nursing.
• Patient on any other antipsychotic medication.
• Patients who, in the opinion of the investigator, pose an imminent risk of suicide or a danger to self or others.
• Known intolerance or lack of response to Ziprasidone, as judged by the investigator.
• 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.
• 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.
• Administration of a depot antipsychotic injection within two dosing interval (for the depot) before randomization.
• Substance or alcohol dependence at enrolment or in the last three months (except for caffeine or nicotine dependence), as defined by DSM-IV criteria.
• Serious, unstable or inadequately treated medical illness as judged by the investigator.
• History of epilepsy or uncontrolled seizures.
• Involvement in the planning and conduct of the study.
• Previous enrolment in the present study.
• Participation in another drug trial within 4 weeks prior enrolment into this study or longer in accordance with local requirements.
• Patients with serum potassium, magnesium and/or calcium levels outside the normal range at baseline.
• Patients with marked liver function abnormalities at baseline, demonstrated by laboratory values, by judgment of the investigator.
• Known serological evidence of HIV, or acute or chronic hepatitis; donation of blood or blood products for transfusion prior to initiation of the treatment with study drug, during the study and for 30 days after the study has ended.
• Known history of QT prolongation (including congenital long QT syndrome).
• Recent acute myocardial infarction or uncompensated heart failure.
• Currently taking other drugs that are known to prolong the QT interval.

• Providence Health & Services
• Pfizer
• MDS Pharma Services