At a glance
ClinicalIndex Comparison Record- ✓Primary diagnosis of Bipolar I Disorder, most recent episode depressed
- ✓Bipolar I diagnosis confirmed by structured Mini International Neuropsychiatric Interview (MINI)
- ✓No psychotic features in current depressive episode
- ✕Schizophrenia or schizoaffective disorder
- ✕Schizophreniform disorder, delusional disorder, or psychotic disorder NOS
- ✕Comorbid Axis I or Axis II disorder that is clinically unstable, requires active treatment, or was primary focus of treatment in prior 6 months
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Six-Week, Randomized, Double-Blind, Multicenter, Fixed-Flexible Dose, Placebo-Controlled Study Evaluating the Efficacy and Safety of Oral Ziprasidone in Outpatients With Bipolar I Depression
In Brief
A Phase 3 clinical trial evaluating Geodon (Ziprasidone) and Placebo for Bipolar Disorder. Completed, enrolled 536 participants across 72 sites.
Detailed Summary
This is a 6-week trial that evaluates the efficacy and safety of Geodon (ziprasidone) in outpatient subjects ages 18 and older with Bipolar Disorder type I, depressed. Subjects are required to undergo a washout period of at least 7 days of any prior med.
Study Details
Timeline
Interventions
Subjects will start at 20mg bid days 1-6, then flexible dosing starting on day 7 between 20-40mg bid (20mg bid or 40mg bid) for the remainder of the 6 week trial
Subjects will start at 20mg bid days 1-2, then 40mg bid days 3-4, them 60mg bid for days 5-6 then flexible dosing starting on day 7 between 60-80mg bid (60 mg bid or 80mg bid) for the remainder of the 6 week trial
Subjects will start on placebo and remain on placebo for the remainder of the 6 week trial