Effectiveness of Ziprasidone for Patients With Schizophrenia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by Soonchunhyang University Hospital.
Recruitment status was  Recruiting
Information provided by:
Soonchunhyang University Hospital
ClinicalTrials.gov Identifier:
First received: September 8, 2010
Last updated: August 2, 2011
Last verified: July 2011

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
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:

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.

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

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         
Catholic University Our Lady of Mercy Hospital Recruiting
Incheon, Korea, Republic of, 403-720
Principal Investigator: Yang-Whan Jeon, MD, PhD         
Inha University Hospital Recruiting
Incheon, Korea, Republic of, 400-700
Principal Investigator: Chul-Eung Kim, 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
  More Information

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:
Schizoaffective Disorder
Metabolic syndrome

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

ClinicalTrials.gov processed this record on October 30, 2014