Efficacy and Tolerability of Switching to Ziprasidone From Other Antipsychotics

NCT ID: NCT00458211

Last Updated: 2020-05-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-05-31
• Study Completion Date: 2008-04-30

Brief Summary

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.

Detailed 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.

Conditions

Schizophrenia; Schizoaffective Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental

Open label change to ziprasidone

Group Type: EXPERIMENTAL

ziprasidone

Intervention Type: DRUG

Ziprasidone by mouth 40mg twice a day (bid) for one day, then 80mg bid; may be increased to 120mg bid after three weeks

Interventions

ziprasidone

Ziprasidone by mouth 40mg twice a day (bid) for one day, then 80mg bid; may be increased to 120mg bid after three weeks

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pfizer

INDUSTRY

Sponsor Role: collaborator

Buffalo Psychiatric Center

OTHER

Sponsor Role: collaborator

Rochester Psychiatric Center

OTHER

Sponsor Role: collaborator

Bronx Psychiatric Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

Nigel Bark MD

Director of Scizophrenia Research

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nigel Bark, MD

Role: PRINCIPAL_INVESTIGATOR

Bronx Psychiatric Center

Jeffrey Grace, MD

Role: PRINCIPAL_INVESTIGATOR

Buffalo Psychiatric Center

Steven Schwarzkopf, MD

Role: PRINCIPAL_INVESTIGATOR

Rochester Psychiatric Center

Locations

Buffalo Psychiatric Center

Buffalo, New York, United States

Bronx Psychiatric Center

The Bronx, New York, United States

Countries

United States

Other Identifiers

BPCIRB 03-02

Identifier Type: -

Identifier Source: org_study_id