Effectiveness of Ziprasidone for Patients With Schizophrenia

Schizophrenia Clinical Trial

Official title:

Study Evaluating Effectiveness of Ziprasidone Using the Overlapped Switching Strategy in Patients With Schizophrenia or Schizoaffective Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01198353
• Other study ID #: IG-KOR-017-2009
• Status: Completed
• Phase: Phase 4
• First received: September 8, 2010
• Last updated: November 18, 2014
• Start date: September 2010
• Est. completion date: December 2013

Study information

• Verified date: November 2014
• Source: Soonchunhyang University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: December 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Psychotic Disorders
• Schizoaffective Disorder
• Schizophrenia

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.

Locations

Country	Name	City	State
Korea, Republic of	Korea University Medical Center Ansan Hospital	Ansan	Gyeonggi-do
Korea, Republic of	Soonchunhyang University Bucheon Hospital	Bucheon
Korea, Republic of	Catholic University Our Lady of Mercy Hospital	Incheon
Korea, Republic of	Inha University Hospital	Incheon
Korea, Republic of	Kangnam Sacred Heart Hospital	Seoul
Korea, Republic of	Korea University Medical Center Guro Hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Soonchunhyang University Hospital	Pfizer

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	A change in the Brief Psychotic Rating Scale (BPRS)		baseline and 12 weeks	No
Secondary	A change in the Lipid profile (Triglyceride, HDL, LDL, Total cholesterol)		baseline and 12 weeks	Yes
Secondary	A change in the Body Mass Index (BMI)		baseline and 12 weeks	Yes
Secondary	A change in the Waist-to-hip ratio		baseline and 12 weeks	Yes
Secondary	UKU side effect rating scale - patient (UKU-SERS-Pat)		baseline	Yes
Secondary	UKU side effect rating scale - patient (UKU-SERS-Pat)		4 weeks	Yes
Secondary	UKU side effect rating scale - patient (UKU-SERS-Pat)		8 weeks	Yes
Secondary	UKU side effect rating scale - patient (UKU-SERS-Pat)		12 weeks	Yes
Secondary	A change in the Clinical Global Impression (CGI)		Baseline and 12 weeks	No
Secondary	A change in the Global Assessment of Functioning (GAF)		Baseline and 12 weeks	No
Secondary	Blood chemistry tests including CBC, electrolyte, LFT, Nitrogen Elements, and protein		Baseline	Yes
Secondary	Blood chemistry tests including CBC, electrolyte, LFT, Nitrogen Elements, and protein		12 weeks	Yes
Secondary	Urinalysis		Baseline	Yes
Secondary	Urinalysis		12 weeks	Yes
Secondary	Electrocardiogram (ECG)		Baseline	Yes
Secondary	Electrocardiogram (ECG)		12 weeks	Yes