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Ziprasidone · 1 trial · 1 indication
YMRS: an 11-item scale that measured the severity of manic episodes. Four items were rated on a scale from 0 (symptom absent) to 8 (symptom extremely severe). The remaining items were rated on a scale from 0 (symptom absent) to 4 (symptom extremely severe). YMRS total score ranged from 0 to 60, higher score indicated higher severity of mania.
| Arm | Type | Description |
|---|---|---|
| Ziprasidone oral capsules | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Ziprasidone oral capsules | DRUG | Oral ziprasidone capsules of 20 mg, 40 mg, 60 mg, and 80 mg strength administered BID. |
| placebo oral capsules | DRUG | Oral placebo capsules of 20 mg, 40 mg, 60 mg, and 80 mg strength administered BID. |
Inclusion Criteria: * DSM-IV criteria for Bipolar I disorder (manic or mixed); age 10 - 17 years Exclusion Criteria: * Imminent risk of suicide or homicide, as judged by the site investigator; any history of serious or unstable medical illness, including risk for QT prolongation
Ziprasidone is an investigational small molecule being studied for the treatment of Bipolar Disorder, specifically for manic or mixed episodes associated with Bipolar I Disorder. It is being evaluated in children and adolescents aged 10 years and older. The drug is currently in Phase 3 clinical development.
Ziprasidone is being developed by Viatris Inc., a global healthcare company traded on the NASDAQ under the ticker symbol VTRS. The company is conducting clinical trials to evaluate the safety and efficacy of this drug in patients with Bipolar Disorder.
Ziprasidone is in Phase 3 clinical development for the treatment of Bipolar Disorder. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The Phase 3 trial has been completed, and the drug remains under clinical investigation.
Ziprasidone has one completed Phase 3 clinical trial, identified as NCT00257166, which evaluated its safety and efficacy in children and adolescents with Bipolar I Disorder (manic or mixed). The trial enrolled 238 participants in the United States and was randomized, double-blind, and placebo-controlled.
Ziprasidone is the generic name of the drug being developed by Viatris Inc. It is also known by its brand name Geodon, which is an antipsychotic medication. In the context of this clinical development program, Ziprasidone is being studied for a new indication in pediatric Bipolar Disorder.