At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 30 enrolled
Drug / intervention
Ziprasidonedrug
Likely dose
Ziprasidone 20-60 mg orally twice dailyAI-extracted
Key inclusion· 3
- ✓Meets DSM-IV criteria for Bipolar II Disorder with at least one documented hypomanic episode
- ✓Currently experiencing a major depressive episode lasting 2 or more weeks but less than 12 months
- ✓Minimum HAM-D score of 18 on the 17-item scale at screen and baseline
Key exclusion· 6
- ✕Meets criteria for Bipolar I Disorder, Schizoaffective Disorder, or Schizophrenia
- ✕Suicidal ideation or history that makes participation unduly risky
- ✕Unstable medical conditions or abnormal thyroid function
- ✕QTc ≥450 msec on initial ECG
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open-Label, Flexible-Dose Trial of the Safety and Efficacy of Geodon in Non-Rapid-Cycling Bipolar II Patients With Major Depression
In Brief
A Phase 4 clinical trial evaluating Ziprasidone for Bipolar II Disorder and Major Depressive Episode. Completed, enrolled 30 participants across 2 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBipolar II Disorder, Major Depressive Episode
CountriesUnited States
CollaboratorsLiebowitz, Michael R., M.D., Pfizer
Timeline
Phase 4CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartFeb 2005
First PostedOct 2005
Primary CompletionFeb 2008
TodayJul 2026
First PostedOct 12, 2005
Enrollment StartFeb 1, 2005
Primary CompletionFeb 1, 2008
TodayJul 2, 2026
Enrollment to primary: 3 yearsPosted 20.7 years ago
Interventions
Ziprasidonedrug
Ziprasidone 20-60 mg BID, taken orally.