A Study of the Efficacy and Safety of Intramuscular Ziprasidone Followed by Oral Ziprasidone for the Treatment of Psychosis

Viatris

Status and phase: Completed; Phase 4

Conditions: Schizophrenia; Acute Exacerbation of Psychosis; Delusional Disorder; Mania

Treatments: Drug: Ziprasidone

Study type: Interventional

Funder types: Industry

Identifiers

NCT00644800

A1281074

Details and patient eligibility

About

To assess the efficacy, safety, and tolerability of intramuscular ziprasidone in the treatment of the acute exacerbation of non-organic psychosis of any etiology, including schizophrenia, acute mania, delusional disorder and others.

Enrollment: 89 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Hospitalized patients with psychosis
• Eligible for intramuscular treatment
• Miminum score of 60 on the PANSS, a score of 14 in the sum of PANSS excitation score and a score of at least 4 in 1 of the following items: poor control of impulses, tension, hostility, uncooperativeness or excitation.

Exclusion criteria

• Treatment with antidepressants or mood stabilizers within seven days prior to the enrollment; for monoamine oxidase inhibitors (MAOIs) and moclobemide, this period must be two weeks; for fluoxetine, five weeks
• Resistance to conventional antipsychotic agents
• A history of epilepsy
• A diagnosis of abuse of substance within the previous 3 months according to the DSMIV criteria.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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89 participants in 1 patient group

Arm A

Experimental group

Treatment:

Drug: Ziprasidone