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Effectiveness of Ziprasidone for Patients With Schizophrenia

NCT ID: NCT01198353

Last Updated: 2014-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

67 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2013-12-31

Brief Summary

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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

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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.

Conditions

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Schizophrenia Schizoaffective Disorder

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Ziprasidone

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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Zeldox

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role collaborator

Soonchunhyang University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Han Yong Jung

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Han Yong Jung, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

DEPARTMENT OF PSYCHIATRY SOONCHUNHYANG UNIVERSITY BUCHEOMN HOSPITAL

Locations

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Korea University Medical Center Ansan Hospital

Ansan, Gyeonggi-do, South Korea

Site Status

Soonchunhyang University Bucheon Hospital

Bucheon-si, , South Korea

Site Status

Inha University Hospital

Incheon, , South Korea

Site Status

Catholic University Our Lady of Mercy Hospital

Incheon, , South Korea

Site Status

Korea University Medical Center Guro Hospital

Seoul, , South Korea

Site Status

Kangnam Sacred Heart Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type BACKGROUND
PMID: 17140769 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17637612 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20470848 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17129654 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19531959 (View on PubMed)

Other Identifiers

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IG-KOR-017-2009

Identifier Type: -

Identifier Source: org_study_id