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Effectiveness of Ziprasidone for Patients With Schizophrenia

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Han Yong Jung, Soonchunhyang University Hospital
ClinicalTrials.gov Identifier:
NCT01198353
First received: September 8, 2010
Last updated: November 18, 2014
Last verified: November 2014
  Purpose

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:


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 ]

Enrollment: 67
Study Start Date: September 2010
Study Completion Date: December 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Zeldox

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.

  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
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

Locations
Korea, Republic of
Korea University Medical Center Ansan Hospital
Ansan, Gyeonggi-do, Korea, Republic of, 425-707
Soonchunhyang University Bucheon Hospital
Bucheon, Korea, Republic of, 420-767
Catholic University Our Lady of Mercy Hospital
Incheon, Korea, Republic of, 403-720
Inha University Hospital
Incheon, Korea, Republic of, 400-700
Kangnam Sacred Heart Hospital
Seoul, Korea, Republic of, 431-070
Korea University Medical Center Guro Hospital
Seoul, Korea, Republic of, 152-703
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, Professor, Soonchunhyang University Hospital
ClinicalTrials.gov Identifier: NCT01198353     History of Changes
Other Study ID Numbers: IG-KOR-017-2009
Study First Received: September 8, 2010
Last Updated: November 18, 2014
Health Authority: Korea: Food and Drug Administration

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

Additional relevant MeSH terms:
Disease
Psychotic Disorders
Schizophrenia
Mental Disorders
Pathologic Processes
Schizophrenia and Disorders with Psychotic Features
Ziprasidone
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 November 20, 2014