A Study of the Efficacy and Safety of Ziprasidone in Patients With Acute Exacerbation of Schizophrenia or Schizoaffective Disorder

Viatris

Status and phase: Terminated; Phase 3

Conditions: Schizophrenia; Schizoaffective Disorder

Treatments: Drug: Ziprasidone

Study type: Interventional

Funder types: Industry

Identifiers

NCT00645229

A1281055

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy and safety of ziprasidone in acute exacerbation of schizophrenia or schizoaffective disorder, including patients with recent onset of symptoms

Full description

The study was prematurely discontinued due to the difficulty of subject recruitment on March 24, 2005. There were no safety concerns that led to the decision to terminate.

Enrollment: 1 patient

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients not currently being treated with antipsychotic medication and neuroleptic naive patients
• Diagnosis of schizophrenia or schizoaffective disorder
• Antipsychotic treatment prior to screening was to be for a cumulative period of less than 5 years

Exclusion criteria

• Patients at immediate risk of committing harm to self or others
• Treatment with clozapine within 3 months prior to baseline
• History of neuroleptic treatment
• Current antipsychotic treatment

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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1 participants in 1 patient group

Arm A

Experimental group

Treatment:

Drug: Ziprasidone