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Label indication GEODON is indicated for the treatment of schizophrenia, as monotherapy for the acute treatment of bipolar manic or mixed episodes, and as an adjunct to lithium or valproate for the maintenance treatment of bipolar disorder. GEODON intramuscular is indicated for acute agitation in schizophrenic patients. FDA label
Also known as Geodon (Ziprasidone)
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...
Top 10 of 11 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Bristol-Myers Squibb Company | BMY | 4 | PHASE3 | Xanomeline and trospium chloride, Xanomeline/Trospium Chloride |
| AbbVie, Inc. | ABBV | 3 | PHASE3 | Cariprazine, ABBV-932, Icalcaprant |
| Xenon Pharmaceuticals Inc. | XENE | 2 | PHASE3 | Azetukalner |
| Eli Lilly and Company | LLY | 1 | PHASE2 | Brenipatide |
| Rapport Therapeutics, Inc. | RAPP | 1 | PHASE2 | RAP-219 |
| Neurocrine Biosciences, Inc. | NBIX | 1 | PHASE2 | NBI-1117568 |
| Alto Neuroscience, Inc. | ANRO | 1 | PHASE2 | ALTO-100 |
| LB Pharmaceuticals, Inc. | LBRX | 1 | PHASE2 | LB-102 |
| BioXcel Therapeutics, Inc. | BTAI | 1 | PHASE1 | BXCL501 |
| Alzamend Neuro, Inc. | ALZN | 1 | PHASE1 | AL001 |
Geodon is an antipsychotic medicine studied for the treatment of bipolar disorder, specifically bipolar I depression. It was evaluated in Phase 3 clinical trials in adults with a diagnosis of bipolar I depression, a condition marked by depressive episodes in people with bipolar I disorder.
Geodon is developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker PFE. Pfizer is the company behind the Geodon clinical development program in psychiatry, including the Phase 3 bipolar I depression studies.
Geodon has been studied in Phase 3 clinical development for bipolar disorder. The program includes two completed Phase 3 trials in bipolar I depression, and no trials in this program are currently listed as active.
Geodon was studied in two completed Phase 3 trials in bipolar I depression: NCT00282464, a six-week flexible dose study that enrolled 392 patients, and NCT00141271, a six-week study that enrolled 536 patients. Both were randomized, double-blind, placebo-controlled trials conducted in the United States in adults aged 18 and older.
Yes, Geodon is the brand name for ziprasidone. Geodon (ziprasidone) is a small molecule medicine, and the two names refer to the same drug, so searches for either name point to the same Pfizer compound and its clinical development program.
The Geodon bipolar disorder program enrolled 928 patients across two completed Phase 3 trials. NCT00282464 enrolled 392 patients and NCT00141271 enrolled 536 patients, both in adults with bipolar I depression. Both studies used randomized, double-blind, placebo-controlled designs.