Effectiveness of Ziprasidone for Patients With Schizophrenia

November 18, 2014 updated by: Han Yong Jung, Soonchunhyang University Hospital

Study Evaluating Effectiveness of Ziprasidone Using the Overlapped Switching Strategy in Patients With Schizophrenia or Schizoaffective Disorder

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

67

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Bucheon, Korea, Republic of, 420-767
        • SoonChunHyang University Bucheon Hospital
      • Incheon, Korea, Republic of, 400-700
        • Inha University Hospital
      • Incheon, Korea, Republic of, 403-720
        • Catholic University Our Lady of Mercy Hospital
      • Seoul, Korea, Republic of, 152-703
        • Korea University Medical Center Guro Hospital
      • Seoul, Korea, Republic of, 431-070
        • KangNam Sacred Heart Hospital
    • Gyeonggi-do
      • Ansan, Gyeonggi-do, Korea, Republic of, 425-707
        • Korea University Medical Center Ansan Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ziprasidone
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.
Drug: Ziprasidone
100% of the past antipsychotic dose will be maintained in week 1, using flexible dosing of 0-100% during next 3 weeks and then discontinued. Ziprasidone will be maintained with flexible dosing of 40-160mg/day during the study period.
Other Names:
  • Zeldox

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
A change in the Brief Psychotic Rating Scale (BPRS)
Time Frame: baseline and 12 weeks
baseline and 12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
A change in the Lipid profile (Triglyceride, HDL, LDL, Total cholesterol)
Time Frame: baseline and 12 weeks
baseline and 12 weeks
A change in the Body Mass Index (BMI)
Time Frame: baseline and 12 weeks
baseline and 12 weeks
A change in the Waist-to-hip ratio
Time Frame: baseline and 12 weeks
baseline and 12 weeks
UKU side effect rating scale - patient (UKU-SERS-Pat)
Time Frame: baseline
baseline
UKU side effect rating scale - patient (UKU-SERS-Pat)
Time Frame: 4 weeks
4 weeks
UKU side effect rating scale - patient (UKU-SERS-Pat)
Time Frame: 8 weeks
8 weeks
UKU side effect rating scale - patient (UKU-SERS-Pat)
Time Frame: 12 weeks
12 weeks
A change in the Clinical Global Impression (CGI)
Time Frame: Baseline and 12 weeks
Baseline and 12 weeks
A change in the Global Assessment of Functioning (GAF)
Time Frame: Baseline and 12 weeks
Baseline and 12 weeks
Blood chemistry tests including CBC, electrolyte, LFT, Nitrogen Elements, and protein
Time Frame: Baseline
Baseline
Blood chemistry tests including CBC, electrolyte, LFT, Nitrogen Elements, and protein
Time Frame: 12 weeks
12 weeks
Urinalysis
Time Frame: Baseline
Baseline
Urinalysis
Time Frame: 12 weeks
12 weeks
Electrocardiogram (ECG)
Time Frame: Baseline
Baseline
Electrocardiogram (ECG)
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Soonchunhyang University Hospital

Collaborators

Pfizer

Investigators

  • Principal Investigator: Han Yong Jung, MD, PhD, DEPARTMENT OF PSYCHIATRY SOONCHUNHYANG UNIVERSITY BUCHEOMN HOSPITAL

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

September 8, 2010

First Submitted That Met QC Criteria

September 9, 2010

First Posted (Estimate)

September 10, 2010

Study Record Updates

Last Update Posted (Estimate)

November 19, 2014

Last Update Submitted That Met QC Criteria

November 18, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IG-KOR-017-2009

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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