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Trial record 1 of 1 for:    NCT01198353
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Effectiveness of Ziprasidone for Patients With Schizophrenia

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ClinicalTrials.gov Identifier: NCT01198353
Recruitment Status : Completed
First Posted : September 10, 2010
Last Update Posted : November 19, 2014
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Han Yong Jung, Soonchunhyang University Hospital

Tracking Information
First Submitted Date  ICMJE September 8, 2010
First Posted Date  ICMJE September 10, 2010
Last Update Posted Date November 19, 2014
Study Start Date  ICMJE September 2010
Actual Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 2, 2011)
A change in the Brief Psychotic Rating Scale (BPRS) [ Time Frame: baseline and 12 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 9, 2010)
  • Brief Psychotic Rating Scale (BPRS) at baseline 4, 6 and 12 weeks [ Time Frame: 12 weeks ]
  • Clinical Global Impression (CGI) at baseline 4, 6 and 12 weeks [ Time Frame: 12 weeks ]
  • Global Assessment of Functioning (GAF) at baseline 4, 6 and 12 weeks [ Time Frame: 12 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 2, 2011)
  • A change in the Lipid profile (Triglyceride, HDL, LDL, Total cholesterol) [ Time Frame: baseline and 12 weeks ]
  • A change in the Body Mass Index (BMI) [ Time Frame: baseline and 12 weeks ]
  • A change in the Waist-to-hip ratio [ Time Frame: baseline and 12 weeks ]
  • UKU side effect rating scale - patient (UKU-SERS-Pat) [ Time Frame: baseline ]
  • UKU side effect rating scale - patient (UKU-SERS-Pat) [ Time Frame: 4 weeks ]
  • UKU side effect rating scale - patient (UKU-SERS-Pat) [ Time Frame: 8 weeks ]
  • UKU side effect rating scale - patient (UKU-SERS-Pat) [ Time Frame: 12 weeks ]
  • A change in the Clinical Global Impression (CGI) [ Time Frame: Baseline and 12 weeks ]
  • A change in the Global Assessment of Functioning (GAF) [ Time Frame: Baseline and 12 weeks ]
  • Blood chemistry tests including CBC, electrolyte, LFT, Nitrogen Elements, and protein [ Time Frame: Baseline ]
  • Blood chemistry tests including CBC, electrolyte, LFT, Nitrogen Elements, and protein [ Time Frame: 12 weeks ]
  • Urinalysis [ Time Frame: Baseline ]
  • Urinalysis [ Time Frame: 12 weeks ]
  • Electrocardiogram (ECG) [ Time Frame: Baseline ]
  • Electrocardiogram (ECG) [ Time Frame: 12 weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 9, 2010)
  • Lipid profile (Triglyceride, HDL, LDL, Total cholesterol) at baseline 4, 6 and 12 weeks [ Time Frame: 12 weeks ]
  • Body Mass Index (BMI) at baseline 4, 6 and 12 weeks [ Time Frame: 12 weeks ]
  • Waist-to-hip ratio at baseline 4, 6 and 12 weeks [ Time Frame: 12 weeks ]
  • UKU side effect rating scale - patient (UKU-SERS-Pat) at baseline 4, 6 and 12 weeks [ Time Frame: 12 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures 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 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 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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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.
Other Name: Zeldox
Study Arms  ICMJE 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.
Intervention: Drug: Ziprasidone
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 Completed
Actual Enrollment  ICMJE
 (submitted: November 18, 2014)
67
Original Estimated Enrollment  ICMJE
 (submitted: September 9, 2010)
70
Actual Study Completion Date  ICMJE December 2013
Actual Primary Completion Date June 2013   (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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01198353
Other Study ID Numbers  ICMJE IG-KOR-017-2009
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Han Yong Jung, Soonchunhyang University 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
PRS Account Soonchunhyang University Hospital
Verification Date November 2014

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