Effectiveness of Ziprasidone for Patients With Schizophrenia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01198353
Recruitment Status : Completed
First Posted : September 10, 2010
Last Update Posted : November 19, 2014
Information provided by (Responsible Party):
Han Yong Jung, Soonchunhyang University Hospital

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.

Condition or disease Intervention/treatment Phase
Schizophrenia Schizoaffective Disorder Drug: Ziprasidone Phase 4

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 : Interventional  (Clinical Trial)
Actual Enrollment : 67 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Study Evaluating Effectiveness of Ziprasidone Using the Overlapped Switching Strategy in Patients With Schizophrenia or Schizoaffective Disorder
Study Start Date : September 2010
Actual Primary Completion Date : June 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. A change in the Brief Psychotic Rating Scale (BPRS) [ Time Frame: baseline and 12 weeks ]

Secondary Outcome Measures :
  1. A change in the Lipid profile (Triglyceride, HDL, LDL, Total cholesterol) [ Time Frame: baseline and 12 weeks ]
  2. A change in the Body Mass Index (BMI) [ Time Frame: baseline and 12 weeks ]
  3. A change in the Waist-to-hip ratio [ Time Frame: baseline and 12 weeks ]
  4. UKU side effect rating scale - patient (UKU-SERS-Pat) [ Time Frame: baseline ]
  5. UKU side effect rating scale - patient (UKU-SERS-Pat) [ Time Frame: 4 weeks ]
  6. UKU side effect rating scale - patient (UKU-SERS-Pat) [ Time Frame: 8 weeks ]
  7. UKU side effect rating scale - patient (UKU-SERS-Pat) [ Time Frame: 12 weeks ]
  8. A change in the Clinical Global Impression (CGI) [ Time Frame: Baseline and 12 weeks ]
  9. A change in the Global Assessment of Functioning (GAF) [ Time Frame: Baseline and 12 weeks ]
  10. Blood chemistry tests including CBC, electrolyte, LFT, Nitrogen Elements, and protein [ Time Frame: Baseline ]
  11. Blood chemistry tests including CBC, electrolyte, LFT, Nitrogen Elements, and protein [ Time Frame: 12 weeks ]
  12. Urinalysis [ Time Frame: Baseline ]
  13. Urinalysis [ Time Frame: 12 weeks ]
  14. Electrocardiogram (ECG) [ Time Frame: Baseline ]
  15. Electrocardiogram (ECG) [ Time Frame: 12 weeks ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01198353

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
Inha University Hospital
Incheon, Korea, Republic of, 400-700
Catholic University Our Lady of Mercy Hospital
Incheon, Korea, Republic of, 403-720
Korea University Medical Center Guro Hospital
Seoul, Korea, Republic of, 152-703
Kangnam Sacred Heart Hospital
Seoul, Korea, Republic of, 431-070
Sponsors and Collaborators
Soonchunhyang University Hospital

Responsible Party: Han Yong Jung, Professor, Soonchunhyang University Hospital Identifier: NCT01198353     History of Changes
Other Study ID Numbers: IG-KOR-017-2009
First Posted: September 10, 2010    Key Record Dates
Last Update Posted: November 19, 2014
Last Verified: November 2014

Keywords provided by Han Yong Jung, Soonchunhyang University Hospital:
Schizoaffective Disorder
Metabolic syndrome

Additional relevant MeSH terms:
Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents