ABOUT THIS STUDY
- 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.
- 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
- 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.
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