Effectiveness of Ziprasidone for Patients With Schizophrenia

This study is currently recruiting participants.

Verified July 2011 by Soonchunhyang University Hospital

Sponsor:

Collaborator:

Pfizer

Information provided by:

Soonchunhyang University Hospital

ClinicalTrials.gov Identifier:

NCT01198353

First received: September 8, 2010

Last updated: August 2, 2011

Last verified: July 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

September 8, 2010

Last Updated Date

August 2, 2011

Start Date ^ICMJE

September 2010

Estimated Primary Completion Date

December 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

A change in the Brief Psychotic Rating Scale (BPRS) [ Time Frame: baseline and 12 weeks ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Brief Psychotic Rating Scale (BPRS) at baseline 4, 6 and 12 weeks [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Clinical Global Impression (CGI) at baseline 4, 6 and 12 weeks [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Global Assessment of Functioning (GAF) at baseline 4, 6 and 12 weeks [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Change History

Complete list of historical versions of study NCT01198353 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

A change in the Lipid profile (Triglyceride, HDL, LDL, Total cholesterol) [ Time Frame: baseline and 12 weeks ] [ Designated as safety issue: Yes ]
A change in the Body Mass Index (BMI) [ Time Frame: baseline and 12 weeks ] [ Designated as safety issue: Yes ]
A change in the Waist-to-hip ratio [ Time Frame: baseline and 12 weeks ] [ Designated as safety issue: Yes ]
UKU side effect rating scale - patient (UKU-SERS-Pat) [ Time Frame: baseline ] [ Designated as safety issue: Yes ]
UKU side effect rating scale - patient (UKU-SERS-Pat) [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
UKU side effect rating scale - patient (UKU-SERS-Pat) [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
UKU side effect rating scale - patient (UKU-SERS-Pat) [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
A change in the Clinical Global Impression (CGI) [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
A change in the Global Assessment of Functioning (GAF) [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
Blood chemistry tests including CBC, electrolyte, LFT, Nitrogen Elements, and protein [ Time Frame: Baseline ] [ Designated as safety issue: Yes ]
Blood chemistry tests including CBC, electrolyte, LFT, Nitrogen Elements, and protein [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
Urinalysis [ Time Frame: Baseline ] [ Designated as safety issue: Yes ]
Urinalysis [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
Electrocardiogram (ECG) [ Time Frame: Baseline ] [ Designated as safety issue: Yes ]
Electrocardiogram (ECG) [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Lipid profile (Triglyceride, HDL, LDL, Total cholesterol) at baseline 4, 6 and 12 weeks [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Body Mass Index (BMI) at baseline 4, 6 and 12 weeks [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Waist-to-hip ratio at baseline 4, 6 and 12 weeks [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
UKU side effect rating scale - patient (UKU-SERS-Pat) at baseline 4, 6 and 12 weeks [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Effectiveness of Ziprasidone for Patients With Schizophrenia

Official Title ^ICMJE

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

Brief Summary

Ziprasidone has been shown to be effective for treatment of positive and negative symptoms in schizophrenia and, to be associated with lower potential for extrapyramidal symptoms and weight gain. However there is little evidence of the effectiveness of switching to ziprasidone in Korean patients with schizophrenia. Although recent studies showed that there was no difference between switching strategies of ziprasidone, expert consensus guidelines prefer overlapped switching methods. Therefore 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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Schizophrenia
Schizoaffective Disorder

Intervention ^ICMJE

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.

Study Arm (s)

Not Provided

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

June 2012

Estimated Primary Completion Date

December 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years to 55 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Han Yong Jung, MD, PhD

82 32 621 5232

hanyjung@schmc.ac.kr

Location Countries ^ICMJE

Korea, Republic of

Administrative Information

NCT Number ^ICMJE

NCT01198353

Other Study ID Numbers ^ICMJE

IG-KOR-017-2009

Has Data Monitoring Committee

Yes

Responsible Party

Han Yong Jung, SOONCHUNHYANG UNIVERSITY BUCHEOMN HOSPITAL

Study Sponsor ^ICMJE

Soonchunhyang University Hospital

Collaborators ^ICMJE

Pfizer

Investigators ^ICMJE

Principal Investigator:

Han Yong Jung, MD, PhD

DEPARTMENT OF PSYCHIATRY SOONCHUNHYANG UNIVERSITY BUCHEOMN HOSPITAL

Information Provided By

Soonchunhyang University Hospital

Verification Date

July 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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