Open-Label Study of Geodon in Non-Rapid Cycling Bipolar II Patients With Major Depression

• Status: Completed
• Trial end date: 2008-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the antidepressant effectiveness of Geodon for the treatment of patients diagnosed with Bipolar II disorder who are currently experiencing a major depressive episode.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Medical Research Network
• Collaborators: Liebowitz, Michael R., M.D.; Pfizer
• Treatments: Ziprasidone

Criteria

Inclusion Criteria:

• patients will meet DSM-IV criteria for Bipolar II Disorder, with at least one hypomanic episode as documented in the medical history or provided by an informant, or have evidence of a clear diagnosis of hypomania

• patients will currently be experiencing a major depressive episode of 2 or more weeks, but less than 12 months duration

• minimum score of 18 on the 17-item HAM-D at screen and baseline

Exclusion Criteria:

• patients will not meet criteria for Bipolar I or Schizoaffective Disorder or Schizophrenia

• patients may have co-morbid anxiety or other Axis I disorders as long as depression dominates the clinical picture

• Suicidal ideation or history that makes participation in a clinical trial unduly risky

• unstable medical conditions or any abnormality in thyroid function

• patients with a QTc of 450msec or greater on the initial ECG

• patients requiring concomitant psychotropic drugs will not be eligible, although patients on such drugs who can undergo washout will be eligible. such patients must have discontinued psychoactive drugs at least 2 weeks before beginning study, with 4 weeks for fluoxetine and depot neuroleptics

• the use of Zolpidem 5-10 mg as needed will be permitted for patients suffering from insomnia, but cannot be taken the night before a scheduled assessment

• patients with dementia or substance abuse in the last 6 months

• pregnant or lactating women will be excluded, as will those not using adequate forms of contraception