Effectiveness of Ziprasidone for Patients With Schizophrenia

Soon Chun Hyang University

Status and phase: Completed; Phase 4

Conditions: Schizophrenia; Schizoaffective Disorder

Treatments: Drug: Ziprasidone

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01198353

IG-KOR-017-2009

Details and patient eligibility

About

This study is designed with the aim to evaluate the clinical effect of the overlapped switching to ziprasidone as well as the efficacy and safe metabolic profile of ziprasidone.

Full description

Patients with schizophrenia or schizoaffective disorder were recruited in this 12-week, multicenter, non-comparative, open-label trial. Prior antipsychotics were allowed to be maintained for up to 4 weeks during the titration of ziprasidone. Efficacy was primarily measured using the 18-item Brief Psychotic Rating Scale (BPRS) at baseline, 4 weeks, 8 weeks, and 12 weeks. Efficacy was secondarily measured by the Clinical Global Impression - Severity (CGI-S) scale and the Global Assessment of Functioning (GAF) scale at each visit. Regarding the metabolic effects of switching to ziprasidone, weight, body mass index (BMI), waist-to-hip ratio (WHR), and lipid profile-including triglyceride (TG), high-density lipoprotein (HDL), low-density lipoprotein (LDL), and total cholesterol levels-were measured at each follow-up visit.

Enrollment: 67 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male and female aged 18-55 years treated with risperidone, olanzapine, amisulpride, quetiapine and typical antipsychotics.
• Both in- and outpatients who met Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria for schizophrenia or schizoaffective disorder.
• Their primary psychiatric clinician determined that they would benefit from a change in their medications, either because of suboptimal efficacy or because of side effects.

Exclusion criteria

• Those who are treated with medications that prolong the QTc interval.
• Those who have any other axis I DSM-IV diagnoses.
• Those who have a history of substance abuse or dependence within 1 month.
• Those who have clinically significant abnormal laboratory values or any other abnormal baseline laboratory findings considered by psychiatrists to be indicative of conditions that might affect the study results.
• Those who have a past history of hypersensitivity or intolerance to ziprasidone.
• Those who have history of clozapine use within 1 month.
• Those who participated in clinical trials within 1 month before entering the study entry.
• Those who have used depot antipsychotics within one cycle before entering the study.
• Those who are pregnant or are breast feeding.
• Those who have a immediate risk of harming self or others or history of suicide attempts in the year before the screening precluded inclusion in the study.
• The patients unable/unlikely to comprehend/follow the protocol.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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67 participants in 1 patient group

Ziprasidone

Experimental group

Description:

During the 12-week study period, patients were prescribed ziprasidone at 20 to 160 mg/day flexibly based on their effectiveness and tolerability. Fifty to one hundred percent of the past antipsychotic dose was maintained in the first week; during next 3 weeks, flexible dosing of 0-100% was used; then, ziprasidone was discontinued. This study included four visits: baseline, week 4, week 8, and week 12. Concomitant benzodiazepines (oral formula or injection) were allowed up to a dose of 4 mg of lorazepam-equivalents per day for anxiety and agitation.

Treatment:

Drug: Ziprasidone