Effectiveness of Ziprasidone for Patients With Schizophrenia

Sponsor

Soonchunhyang University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT01198353

Collaborator

Pfizer (Industry)

Enrollment

Locations

Arm

Duration (Months)

11.2

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia Schizoaffective Disorder	Drug: Ziprasidone	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

67 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Sep 1, 2010

Actual Primary Completion Date :

Jun 1, 2013

Actual Study Completion Date :

Dec 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
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.	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 Names: Zeldox

Arm

Intervention/Treatment

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.

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 Names:

Zeldox

Outcome Measures

Primary Outcome Measures

A change in the Brief Psychotic Rating Scale (BPRS) [baseline and 12 weeks]

Secondary Outcome Measures

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]
UKU side effect rating scale - patient (UKU-SERS-Pat) [8 weeks]
UKU side effect rating scale - patient (UKU-SERS-Pat) [12 weeks]
A change in the Clinical Global Impression (CGI) [Baseline and 12 weeks]
A change in the Global Assessment of Functioning (GAF) [Baseline and 12 weeks]
Blood chemistry tests including CBC, electrolyte, LFT, Nitrogen Elements, and protein [Baseline]
Blood chemistry tests including CBC, electrolyte, LFT, Nitrogen Elements, and protein [12 weeks]
Urinalysis [Baseline]
Urinalysis [12 weeks]
Electrocardiogram (ECG) [Baseline]
Electrocardiogram (ECG) [12 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Korea University Medical Center Ansan Hospital	Ansan	Gyeonggi-do	Korea, Republic of	425-707
2	Soonchunhyang University Bucheon Hospital	Bucheon		Korea, Republic of	420-767
3	Inha University Hospital	Incheon		Korea, Republic of	400-700
4	Catholic University Our Lady of Mercy Hospital	Incheon		Korea, Republic of	403-720
5	Korea University Medical Center Guro Hospital	Seoul		Korea, Republic of	152-703
6	Kangnam Sacred Heart Hospital	Seoul		Korea, Republic of	431-070