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Effectiveness of Ziprasidone for Patients With Schizophrenia

Primary Purpose

Schizophrenia, Schizoaffective Disorder

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Ziprasidone
Sponsored by
Soonchunhyang University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia, Schizoaffective Disorder, Ziprasidone, Switch, Metabolic syndrome

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Korea University Medical Center Ansan Hospital
  • Soonchunhyang University Bucheon Hospital
  • Inha University Hospital
  • Catholic University Our Lady of Mercy Hospital
  • Korea University Medical Center Guro Hospital
  • Kangnam Sacred Heart Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ziprasidone

Arm Description

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.

Outcomes

Primary Outcome Measures

A change in the Brief Psychotic Rating Scale (BPRS)

Secondary Outcome Measures

A change in the Lipid profile (Triglyceride, HDL, LDL, Total cholesterol)
A change in the Body Mass Index (BMI)
A change in the Waist-to-hip ratio
UKU side effect rating scale - patient (UKU-SERS-Pat)
UKU side effect rating scale - patient (UKU-SERS-Pat)
UKU side effect rating scale - patient (UKU-SERS-Pat)
UKU side effect rating scale - patient (UKU-SERS-Pat)
A change in the Clinical Global Impression (CGI)
A change in the Global Assessment of Functioning (GAF)
Blood chemistry tests including CBC, electrolyte, LFT, Nitrogen Elements, and protein
Blood chemistry tests including CBC, electrolyte, LFT, Nitrogen Elements, and protein
Urinalysis
Urinalysis
Electrocardiogram (ECG)
Electrocardiogram (ECG)

Full Information

First Posted
September 8, 2010
Last Updated
November 18, 2014
Sponsor
Soonchunhyang University Hospital
Collaborators
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT01198353
Brief Title
Effectiveness of Ziprasidone for Patients With Schizophrenia
Official Title
Study Evaluating Effectiveness of Ziprasidone Using the Overlapped Switching Strategy in Patients With Schizophrenia or Schizoaffective Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Soonchunhyang University Hospital
Collaborators
Pfizer

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Schizoaffective Disorder
Keywords
Schizophrenia, Schizoaffective Disorder, Ziprasidone, Switch, Metabolic syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
67 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ziprasidone
Arm Type
Experimental
Arm Description
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 Type
Drug
Intervention Name(s)
Ziprasidone
Other Intervention Name(s)
Zeldox
Intervention Description
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.
Primary Outcome Measure Information:
Title
A change in the Brief Psychotic Rating Scale (BPRS)
Time Frame
baseline and 12 weeks
Secondary Outcome Measure Information:
Title
A change in the Lipid profile (Triglyceride, HDL, LDL, Total cholesterol)
Time Frame
baseline and 12 weeks
Title
A change in the Body Mass Index (BMI)
Time Frame
baseline and 12 weeks
Title
A change in the Waist-to-hip ratio
Time Frame
baseline and 12 weeks
Title
UKU side effect rating scale - patient (UKU-SERS-Pat)
Time Frame
baseline
Title
UKU side effect rating scale - patient (UKU-SERS-Pat)
Time Frame
4 weeks
Title
UKU side effect rating scale - patient (UKU-SERS-Pat)
Time Frame
8 weeks
Title
UKU side effect rating scale - patient (UKU-SERS-Pat)
Time Frame
12 weeks
Title
A change in the Clinical Global Impression (CGI)
Time Frame
Baseline and 12 weeks
Title
A change in the Global Assessment of Functioning (GAF)
Time Frame
Baseline and 12 weeks
Title
Blood chemistry tests including CBC, electrolyte, LFT, Nitrogen Elements, and protein
Time Frame
Baseline
Title
Blood chemistry tests including CBC, electrolyte, LFT, Nitrogen Elements, and protein
Time Frame
12 weeks
Title
Urinalysis
Time Frame
Baseline
Title
Urinalysis
Time Frame
12 weeks
Title
Electrocardiogram (ECG)
Time Frame
Baseline
Title
Electrocardiogram (ECG)
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Han Yong Jung, MD, PhD
Organizational Affiliation
DEPARTMENT OF PSYCHIATRY SOONCHUNHYANG UNIVERSITY BUCHEOMN HOSPITAL
Official's Role
Principal Investigator
Facility Information:
Facility Name
Korea University Medical Center Ansan Hospital
City
Ansan
State/Province
Gyeonggi-do
ZIP/Postal Code
425-707
Country
Korea, Republic of
Facility Name
Soonchunhyang University Bucheon Hospital
City
Bucheon
ZIP/Postal Code
420-767
Country
Korea, Republic of
Facility Name
Inha University Hospital
City
Incheon
ZIP/Postal Code
400-700
Country
Korea, Republic of
Facility Name
Catholic University Our Lady of Mercy Hospital
City
Incheon
ZIP/Postal Code
403-720
Country
Korea, Republic of
Facility Name
Korea University Medical Center Guro Hospital
City
Seoul
ZIP/Postal Code
152-703
Country
Korea, Republic of
Facility Name
Kangnam Sacred Heart Hospital
City
Seoul
ZIP/Postal Code
431-070
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
17140769
Citation
Kudla D, Lambert M, Domin S, Kasper S, Naber D. Effectiveness, tolerability, and safety of ziprasidone in patients with schizophrenia or schizoaffective disorder: results of a multi-centre observational trial. Eur Psychiatry. 2007 Apr;22(3):195-202. doi: 10.1016/j.eurpsy.2006.06.004. Epub 2006 Nov 29.
Results Reference
background
PubMed Identifier
17637612
Citation
Weiden PJ, Newcomer JW, Loebel AD, Yang R, Lebovitz HE. Long-term changes in weight and plasma lipids during maintenance treatment with ziprasidone. Neuropsychopharmacology. 2008 Apr;33(5):985-94. doi: 10.1038/sj.npp.1301482. Epub 2007 Jul 18.
Results Reference
background
PubMed Identifier
20470848
Citation
Stip E, Zhornitsky S, Potvin S, Tourjman V. Switching from conventional antipsychotics to ziprasidone: a randomized, open-label comparison of regimen strategies. Prog Neuropsychopharmacol Biol Psychiatry. 2010 Aug 16;34(6):997-1000. doi: 10.1016/j.pnpbp.2010.05.010. Epub 2010 May 12.
Results Reference
background
PubMed Identifier
17129654
Citation
Montes JM, Rodriguez JL, Balbo E, Sopelana P, Martin E, Soto JA, Delgado JF, Diez T, Villardaga I. Improvement in antipsychotic-related metabolic disturbances in patients with schizophrenia switched to ziprasidone. Prog Neuropsychopharmacol Biol Psychiatry. 2007 Mar 30;31(2):383-8. doi: 10.1016/j.pnpbp.2006.10.002. Epub 2006 Nov 28.
Results Reference
background
PubMed Identifier
19531959
Citation
Alptekin K, Hafez J, Brook S, Akkaya C, Tzebelikos E, Ucok A, El Tallawy H, Danaci AE, Lowe W, Karayal ON. Efficacy and tolerability of switching to ziprasidone from olanzapine, risperidone or haloperidol: an international, multicenter study. Int Clin Psychopharmacol. 2009 Sep;24(5):229-38. doi: 10.1097/YIC.0b013e32832c2624.
Results Reference
background

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Effectiveness of Ziprasidone for Patients With Schizophrenia

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