Effectiveness of Ziprasidone for Patients With Schizophrenia

• ClinicalTrials.gov Identifier: NCT01198353
• Recruitment Status: Completed
• First Posted: September 10, 2010
• Last Update Posted: November 19, 2014
• Sponsor: Soonchunhyang University Hospital
• Collaborator: Pfizer
• Information provided by (Responsible Party): Han Yong Jung, Soonchunhyang University Hospital

Tracking Information

• First Submitted Date: September 8, 2010
• First Posted Date: September 10, 2010
• Last Update Posted Date: November 19, 2014
• Study Start Date: September 2010
• Actual Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: August 2, 2011): A change in the Brief Psychotic Rating Scale (BPRS) [ Time Frame: baseline and 12 weeks ]

Original Primary Outcome Measures (submitted: September 9, 2010)

• Brief Psychotic Rating Scale (BPRS) at baseline 4, 6 and 12 weeks [ Time Frame: 12 weeks ]
• Clinical Global Impression (CGI) at baseline 4, 6 and 12 weeks [ Time Frame: 12 weeks ]
• Global Assessment of Functioning (GAF) at baseline 4, 6 and 12 weeks [ Time Frame: 12 weeks ]

Current Secondary Outcome Measures (submitted: August 2, 2011)

• A change in the Lipid profile (Triglyceride, HDL, LDL, Total cholesterol) [ Time Frame: baseline and 12 weeks ]
• A change in the Body Mass Index (BMI) [ Time Frame: baseline and 12 weeks ]
• A change in the Waist-to-hip ratio [ Time Frame: baseline and 12 weeks ]
• UKU side effect rating scale - patient (UKU-SERS-Pat) [ Time Frame: baseline ]
• UKU side effect rating scale - patient (UKU-SERS-Pat) [ Time Frame: 4 weeks ]
• UKU side effect rating scale - patient (UKU-SERS-Pat) [ Time Frame: 8 weeks ]
• UKU side effect rating scale - patient (UKU-SERS-Pat) [ Time Frame: 12 weeks ]
• A change in the Clinical Global Impression (CGI) [ Time Frame: Baseline and 12 weeks ]
• A change in the Global Assessment of Functioning (GAF) [ Time Frame: Baseline and 12 weeks ]
• Blood chemistry tests including CBC, electrolyte, LFT, Nitrogen Elements, and protein [ Time Frame: Baseline ]
• Blood chemistry tests including CBC, electrolyte, LFT, Nitrogen Elements, and protein [ Time Frame: 12 weeks ]
• Urinalysis [ Time Frame: Baseline ]
• Urinalysis [ Time Frame: 12 weeks ]
• Electrocardiogram (ECG) [ Time Frame: Baseline ]
• Electrocardiogram (ECG) [ Time Frame: 12 weeks ]

Original Secondary Outcome Measures (submitted: September 9, 2010)

• Lipid profile (Triglyceride, HDL, LDL, Total cholesterol) at baseline 4, 6 and 12 weeks [ Time Frame: 12 weeks ]
• Body Mass Index (BMI) at baseline 4, 6 and 12 weeks [ Time Frame: 12 weeks ]
• Waist-to-hip ratio at baseline 4, 6 and 12 weeks [ Time Frame: 12 weeks ]
• UKU side effect rating scale - patient (UKU-SERS-Pat) at baseline 4, 6 and 12 weeks [ Time Frame: 12 weeks ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Schizophrenia
• Schizoaffective Disorder

Intervention

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

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 *

• 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. Epub 2006 Nov 29.
• 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. Epub 2007 Jul 18.
• 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.
• 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. Epub 2006 Nov 28.
• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: November 18, 2014): 67
• Original Estimated Enrollment (submitted: September 9, 2010): 70
• Actual Study Completion Date: December 2013
• Actual Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 55 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Korea, Republic of

Administrative Information

• NCT Number: NCT01198353
• Other Study ID Numbers: IG-KOR-017-2009
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Han Yong Jung, Soonchunhyang University Hospital
• Study Sponsor: Soonchunhyang University Hospital
• Collaborators: Pfizer

Investigators

• Principal Investigator: Han Yong Jung, MD, PhD; DEPARTMENT OF PSYCHIATRY SOONCHUNHYANG UNIVERSITY BUCHEOMN HOSPITAL

• PRS Account: Soonchunhyang University Hospital
• Verification Date: November 2014