NCT01198353

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
67

participants targeted

Target at P25-P50 for phase_4 schizophrenia

Timeline
Completed

Started Sep 2010

Typical duration for phase_4 schizophrenia

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

September 8, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 10, 2010

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

November 19, 2014

Status Verified

November 1, 2014

Enrollment Period

2.8 years

First QC Date

September 8, 2010

Last Update Submit

November 18, 2014

Conditions

SchizophreniaSchizoaffective Disorder

Keywords

SchizophreniaSchizoaffective DisorderZiprasidoneSwitchMetabolic syndrome

Outcome Measures

Primary Outcomes (1)

  • A change in the Brief Psychotic Rating Scale (BPRS)

    baseline and 12 weeks

Secondary Outcomes (15)

  • A change in the Lipid profile (Triglyceride, HDL, LDL, Total cholesterol)

    baseline and 12 weeks

  • A change in the Body Mass Index (BMI)

    baseline and 12 weeks

  • A change in the Waist-to-hip ratio

    baseline and 12 weeks

  • UKU side effect rating scale - patient (UKU-SERS-Pat)

    baseline

  • UKU side effect rating scale - patient (UKU-SERS-Pat)

    4 weeks

  • +10 more secondary outcomes

Study Arms (1)

Ziprasidone

EXPERIMENTAL

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

Interventions

ZiprasidoneDRUG

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.

Also known as: Zeldox
Ziprasidone

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • The patients unable/unlikely to comprehend/follow the protocol.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Korea University Medical Center Ansan Hospital

Ansan, Gyeonggi-do, 425-707, South Korea

Location

Soonchunhyang University Bucheon Hospital

Bucheon-si, 420-767, South Korea

Location

Inha University Hospital

Incheon, 400-700, South Korea

Location

Catholic University Our Lady of Mercy Hospital

Incheon, 403-720, South Korea

Location

Korea University Medical Center Guro Hospital

Seoul, 152-703, South Korea

Location

Kangnam Sacred Heart Hospital

Seoul, 431-070, South Korea

Location

Related Publications (5)

  • 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.

    PMID: 17140769BACKGROUND

  • 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.

    PMID: 17637612BACKGROUND

  • 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.

    PMID: 20470848BACKGROUND

  • 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.

    PMID: 17129654BACKGROUND

  • 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.

    PMID: 19531959BACKGROUND

MeSH Terms

Conditions

SchizophreniaPsychotic DisordersMetabolic Syndrome

Interventions

ziprasidone

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersInsulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Han Yong Jung, MD, PhD

    DEPARTMENT OF PSYCHIATRY SOONCHUNHYANG UNIVERSITY BUCHEOMN HOSPITAL

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 8, 2010

First Posted

September 10, 2010

Study Start

September 1, 2010

Primary Completion

June 1, 2013

Study Completion

December 1, 2013

Last Updated

November 19, 2014

Record last verified: 2014-11

Locations

KR(6)