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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
  Purpose

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.


Condition Intervention Phase
Schizophrenia
Schizoaffective Disorder
 Drug: Ziprasidone
 Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Study Evaluating Effectiveness of Ziprasidone Using the Overlapped Switching Strategy in Patients With Schizophrenia or Schizoaffective Disorder

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Soonchunhyang University Hospital:

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

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 70
Study Start Date: September 2010
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01198353

Contacts
Contact: Han Yong Jung, MD, PhD 82 32 621 5232 hanyjung@schmc.ac.kr

Locations
Korea, Republic of
Korea University Medical Center Ansan Hospital Recruiting
Ansan, Gyeonggi-do, Korea, Republic of, 425-707
Contact: Young-Hoon Ko, MD, PhD         koyh@korea.ac.kr    
Principal Investigator: Young-Hoon Ko, MD, PhD            
Soonchunhyang University Bucheon Hospital Recruiting
Bucheon, Korea, Republic of, 420-767
Principal Investigator: Han Yong Jung, MD, PhD            
Inha University Hospital Recruiting
Incheon, Korea, Republic of, 400-700
Principal Investigator: Chul-Eung Kim, MD, PhD            
Catholic University Our Lady of Mercy Hospital Recruiting
Incheon, Korea, Republic of, 403-720
Principal Investigator: Yang-Whan Jeon, MD, PhD            
Kangnam Sacred Heart Hospital Recruiting
Seoul, Korea, Republic of, 431-070
Principal Investigator: Jung Seo Yi, MD, PhD            
Korea University Medical Center Guro Hospital Recruiting
Seoul, Korea, Republic of, 152-703
Principal Investigator: Seung-Hyun Kim, MD, PhD            
Sponsors and Collaborators
Soonchunhyang University Hospital
Pfizer
Investigators
Principal Investigator: Han Yong Jung, MD, PhD DEPARTMENT OF PSYCHIATRY SOONCHUNHYANG UNIVERSITY BUCHEOMN HOSPITAL
  More Information

Publications:

Responsible Party: Han Yong Jung, SOONCHUNHYANG UNIVERSITY BUCHEOMN HOSPITAL
ClinicalTrials.gov Identifier: NCT01198353     History of Changes
Other Study ID Numbers: IG-KOR-017-2009
Study First Received: September 8, 2010
Last Updated: August 2, 2011
Health Authority: Korea: Food and Drug Administration

Keywords provided by Soonchunhyang University Hospital:
Schizophrenia
Schizoaffective Disorder
Ziprasidone
Switch
Metabolic syndrome

Additional relevant MeSH terms:
Psychotic Disorders
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Ziprasidone
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
 Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents

ClinicalTrials.gov processed this record on May 23, 2013