A Phase 3, randomized, 6-month, double blind trial in subjects with Bipolar I Disorder to evaluate the continued safety and maintenance of effect of Ziprasidone plus a mood stabilizer (vs placebo plus a mood stabilizer) following a minimum of 2 months of response to open-label treatment with both agents. - NA

Pfizer Pharma GmbH0 sites512 target enrollmentFebruary 17, 2006

Overview

No summary available.

Registry

who.int

Start Date

February 17, 2006

End Date

TBD

Last Updated

12 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•Demographic and General Inclusion Criteria
•Subject must:
•1\.Personally sign the written informed consent after the scope and nature of the investigation has been explained to them before any study\-specific procedure/evaluation is initiated or performed.
•2\.Be male or female.
•3\.Be at least 18 years of age and the age of legal consent.
•4\.Be a female who is not of child\-bearing potential (ie, surgically sterile or postmenopausal for at least one year), or be non\-pregnant and using an acceptable method of birth control for at least one month prior to the screening visit or prior to having sexual relations during the study or be one who abstains from sex.
•Subject must meet all of the following criteria:
•·Agree to avoid pregnancy during the study and
•·Have a negative serum pregnancy test (\-HCG) at screening and
•·Use one of the birth control methods listed below for the duration of

•Psychiatric exclusion criteria:
•Subject must not:
•1\.Suffer from ultra\-fast rapid cycling (defined as 8 or more mood episodes over the previous 12 month period).
•2\.Be clinically stable on another treatment regimen that is also well tolerated (ie, clinical reason must exist to discontinue current treatment and enter subject into protocol).
•3\.Be at an imminent risk of harm to self or to others.
•4\.Have a diagnosis of mental retardation or organic brain syndrome.
•5\.Have a substance\-induced psychotic disorder or behavioral disturbance thought to be due to substance abuse.
•6\.Have a current (within 2 months prior to screening) DSM\-IV\-TR™ defined substance abuse/dependence (excluding nicotine and caffeine).
•7\.Have a history of treatment resistance to at least two other antipsychotic medications (after adequate dose and length of treatment).
•8\.Have a history of treatment resistance or intolerance to ziprasidone (adequate length and dose of treatment).