Overview
Disorders such as schizophrenia and bipolar disorder can significantly impair mood, cognition, and behavior. These mental illnesses can often be accompanied by comorbidities such as depression and substance abuse, and can significantly impact the quality of life of patients and caregivers. Luckily, several treatment options for psychotic disorders have been introduced to market since the realization of chlorpromazine's antipsychotic properties in 1952. Second generation antipsychotics (commonly referred to as atypical antipsychotics) include clozapine, quetiapine, olanzapine, aripiprazole and ziprasidone among others, and are generally thought to be as efficacious as first generation antipsychotics but differ in their adverse effect profiles. First generation antipsychotics are associated with extrapyramidal adverse effects while atypical antipsychotics are linked to weight gain, impaired glucose tolerance and metabolic syndrome. Ziprasidone is used to treat schizophrenia and bipolar disorder. It can effectively reduce the rate and time of relapses in schizophrenia, and can be used to treat manic episodes in bipolar disorder although the mechanism of action is unknown. Although ziprasidone is classified as an atypical antipsychotic, it appears to have a lower incidence of metabolic adverse effects compared to other medications in the same class.
Indication
In its oral form, ziprasidone is approved for the treatment of schizophrenia, as monotherapy for acute treatment of manic or mixed episodes related to bipolar I disorder, and as adjunctive therapy to lithium or valproate for maintenance treatment of bipolar I disorder. The injectable formulation is approved only for treatment of acute agitation in schizophrenia.
Associated Conditions
- Acute Agitation
- Agitation
- Bipolar 1 Disorder
- Psychosis
- Schizophrenia
- Treatment Resistant Major Depressive Disorder
- Acute Manic episode
- Acute Mixed manic depressive episode
Clinical Trials
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Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2013/05/01 | Phase 4 | Terminated | |||
2012/10/25 | Phase 4 | Completed | |||
2012/04/20 | Phase 1 | Completed | |||
2012/04/20 | Phase 1 | Completed | |||
2011/12/23 | N/A | Completed | |||
2011/12/05 | Not Applicable | Completed | |||
2011/02/11 | Phase 4 | Completed | |||
2010/09/29 | Phase 3 | Completed | |||
2010/09/10 | Phase 4 | Completed | |||
2010/08/20 | Phase 4 | Completed |
FDA Drug Approvals
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Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
Rebel Distributors Corp | 42254-170 | ORAL | 40 mg in 1 1 | 2/15/2012 | |
A-S Medication Solutions | 50090-4821 | ORAL | 20 mg in 1 1 | 2/24/2022 | |
AvPAK | 50268-811 | ORAL | 20 mg in 1 1 | 1/8/2024 | |
ROERIG | 0049-0054 | ORAL | 40 mg in 1 1 | 1/13/2025 | |
Sandoz Inc | 0781-2167 | ORAL | 60 mg in 1 1 | 1/27/2020 | |
TYA Pharmaceuticals | 64725-2164 | ORAL | 20 mg in 1 1 | 10/22/2012 | |
A-S Medication Solutions | 50090-3349 | ORAL | 40 mg in 1 1 | 3/30/2021 | |
REMEDYREPACK INC. | 70518-2940 | ORAL | 20 mg in 1 1 | 3/8/2024 | |
Viatris Specialty LLC | 58151-134 | ORAL | 80 mg in 1 1 | 3/5/2024 | |
ROERIG | 0049-0354 | ORAL | 40 mg in 1 1 | 1/13/2025 |
EMA Drug Approvals
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CIMA AEMPS Drug Approvals
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Philippines FDA Drug Approvals
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Saudi SFDA Drug Approvals
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Malaysia NPRA Drug Approvals
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UK EMC Drug Information
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