Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Geodon · 2 trials · 1 indication
Change is observed value at each visit minus baseline value. MADRS:10-item instrument measuring depression; scale range between 0(Normal) - 6(most abnormal)for each item. Total possible score is 0 - 60. Overall is average response Week 1 - Week 6.
Change is observed value at each visit minus baseline value. Overall is average response of Weeks 1 - 6. MADRS is 10-item instrument measuring depression; scale 0(Normal) and 6(most abnormal). Total possible score is 0 - 60.
| Arm | Type | Description |
|---|---|---|
| Ziprasidone 20 and 60mg | ACTIVE_COMPARATOR | For the Ziprasidone arm, the Baseline card will contain 20 mg bid (one 20 mg capsule) for days 1-2 and 40 mg bid (two 20 mg capsules) for days 3-6. Cards A, B, C, and D will contain either 20 mg bid (one 20 mg capsule), 40 mg bid (two 20 mg capsules), 60 mg bid (one 60 mg capsule), or 80 mg bid (one 60 mg capsule and one 20 mg capsule). |
| Placebo | PLACEBO_COMPARATOR | - |
| 20-40mg BID arm | ACTIVE_COMPARATOR | - |
| 60-80mg bid arm | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | Subjects will start on placebo and remain on placebo for six weeks. All cards for the Placebo arm will be 0 mg bid. |
| Geodon (Ziprasidone) | DRUG | Ziprasidone flexible dosing treatment arm (20-80 mg bid). For the Ziprasidone arm, the Baseline card will contain 20 mg bid (one 20 mg capsule) for days 1-2 and 40 mg bid (two 20 mg capsules) for days 3-6. Cards A, B, C, and D will contain either 20 mg bid (one 20 mg capsule), 40 mg bid (two 20 mg capsules), 60 mg bid (one 60 mg capsule), or 80 mg bid (one 60 mg capsule and one 20 mg capsule). |
Inclusion Criteria: * Subjects must have a primary diagnosis of Bipolar I Disorder, most recent episode depressed, with or without rapid cycling, without psychotic features, as defined in DSM-IV-TR (296.5X) and confirmed by a structured Mini International Neuropsychiatric Interview (MINI) Exclusio...
Geodon is an investigational small molecule being studied for the treatment of bipolar disorder, specifically bipolar I depression. It is being evaluated in Phase 3 clinical trials to assess its efficacy and safety in patients with this condition. Geodon is developed by Pfizer, Inc. (NYSE: PFE).
Geodon is developed by Pfizer, Inc., a biopharmaceutical company listed on the New York Stock Exchange under the ticker symbol PFE. Pfizer is conducting clinical trials to evaluate Geodon for the treatment of bipolar disorder, specifically bipolar I depression.
Geodon is in Phase 3 clinical development for the treatment of bipolar disorder, specifically bipolar I depression. It is an investigational drug and has not been approved by regulatory authorities. Two Phase 3 trials have been completed, with a total enrollment of 928 patients.
Geodon has been studied in two completed Phase 3 clinical trials for bipolar I depression: NCT00141271, a six-week study with 536 patients, and NCT00282464, a six-week flexible dose study with 392 patients. Both trials were randomized, double-blind, placebo-controlled, and conducted in the United States.
Geodon is the brand name for ziprasidone, an atypical antipsychotic. In the context of bipolar disorder, Geodon is being investigated for the treatment of bipolar I depression. Pfizer, Inc. is the developer of Geodon, and it is currently in Phase 3 clinical trials for this indication.