Status:
COMPLETED
Effectiveness of Ziprasidone for Patients With Schizophrenia
Lead Sponsor:
Soonchunhyang University Hospital
Collaborating Sponsors:
Pfizer
Conditions:
Schizophrenia
Schizoaffective Disorder
Eligibility:
All Genders
18-55 years
Phase:
PHASE4
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 w...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
67 Patients enrolled
Trial Details
Trial ID
NCT01198353
Start Date
September 1 2010
End Date
December 1 2013
Last Update
November 19 2014
Active Locations (6)
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1
Korea University Medical Center Ansan Hospital
Ansan, Gyeonggi-do, South Korea, 425-707
2
Soonchunhyang University Bucheon Hospital
Bucheon-si, South Korea, 420-767
3
Inha University Hospital
Incheon, South Korea, 400-700
4
Catholic University Our Lady of Mercy Hospital
Incheon, South Korea, 403-720