Effectiveness of Ziprasidone for Patients With Schizophrenia
NCT01198353
ABOUT THIS STUDY
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Adult Trials: 18+ Years
- 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.
- 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.
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| 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 |
| |||
| 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 * |
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* 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 | 67 | |||
| Original Estimated Enrollment ICMJE | 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:
Exclusion Criteria:
| |||
| Sex/Gender ICMJE |
| |||
| 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 |
| |||
| 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 | ||||