Efficacy and Tolerability of Switching to Ziprasidone From Other Antipsychotics

Bronx Psychiatric Center

Status and phase: Completed; Phase 4

Conditions: Schizophrenia; Schizoaffective Disorder

Treatments: Drug: ziprasidone

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00458211

BPCIRB 03-02

Details and patient eligibility

About

Because ziprasidone has not been extensively studied and is not widely accepted in the severely mentally ill in State hospitals this study aims to demonstrate its effectiveness and relative lack of side effects. 75 patients with schizophrenia or schizoaffective disorder who need a change of medication because of ineffectiveness or side effects will be changed to ziprasidone and followed with detailed assessments for eight weeks.

The hypothesis is that they will improve and have fewer side effects.

Full description

Ziprasidone has been found in studies and practice to be efficacious and tolerated well but has not been well studied or well accepted in the very severely ill in State Hospitals. This study aims to fill that gap by examining 75 patients with schizophrenia or schizoaffective disorder who require a change of medication because of poor response or unacceptable side effects.

After signing consent and having a baseline assessment they will, if necessary, be reduced to one antipsychotic then started on ziprasidone, increasing to 160mg the second day. The one antipsychotic they had been on will be reduced over a week and stopped. The ziprasidone can be increased to 240mg after three weeks if necessary.

The study will last eight weeks with efficacy assessed by Clinical Global Impressions (CGI), Positive and Negative Syndrome Scale (PANSS) every two weeks and Brief Assessment of Cognition, Calgary Depression Scale for Schizophrenia, Personal Evaluation of Transitions in Treatment and Medical Outcomes Study Cognitive Questions at the beginning and end. Side effects will be measured by movement disorder scales (Simpson-Angus scale for Parkinsonism (SANRS), Abnormal Involuntary Movement Scale (AIMS) and Barnes Akathisia Scale (BAS)), ECG and weight and blood metabolic measures.

The hypothesis is that ziprasidone will be generally effective and that side effects especially metabolic indices will be reduced.

Enrollment: 40 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Schizophrenia or schizoaffective
• Capacity to give consent
• Stable, on the same medication for a month but only partial response or with unacceptable side effects 18-65 years of age

Exclusion criteria

• Repeated non-compliance
• Current depot medication
• Active medical conditions
• QTc >500msec
• Previous non-response
• Previous treatment with ziprasidone

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Experimental

Experimental group

Description:

Open label change to ziprasidone

Treatment:

Drug: ziprasidone