Skip to main content
OpenTrials
Completed

NCT Number: NCT01198353

Effectiveness of Ziprasidone for Patients With Schizophrenia

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Schizophrenia Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Mental Disorders Metabolic Diseases Metabolic Syndrome Nutritional and Metabolic Diseases Psychotic Disorders Schizoaffective Disorder Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Korea University Medical Center Ansan Hospital, Ansan, Gyeonggi-do, South Korea

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ziprasidone

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.

Other names: Zeldox

Primary outcomes

  1. A change in the Brief Psychotic Rating Scale (BPRS)

    Time frame: baseline and 12 weeks

Secondary outcomes

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

    Time frame: baseline and 12 weeks

  2. A change in the Body Mass Index (BMI)

    Time frame: baseline and 12 weeks

  3. A change in the Waist-to-hip ratio

    Time frame: baseline and 12 weeks

  4. UKU side effect rating scale - patient (UKU-SERS-Pat)

    Time frame: baseline

  5. UKU side effect rating scale - patient (UKU-SERS-Pat)

    Time frame: 4 weeks

  6. UKU side effect rating scale - patient (UKU-SERS-Pat)

    Time frame: 8 weeks

  7. UKU side effect rating scale - patient (UKU-SERS-Pat)

    Time frame: 12 weeks

  8. A change in the Clinical Global Impression (CGI)

    Time frame: Baseline and 12 weeks

  9. A change in the Global Assessment of Functioning (GAF)

    Time frame: Baseline and 12 weeks

  10. Blood chemistry tests including CBC, electrolyte, LFT, Nitrogen Elements, and protein

    Time frame: Baseline

  11. Blood chemistry tests including CBC, electrolyte, LFT, Nitrogen Elements, and protein

    Time frame: 12 weeks

  12. Urinalysis

    Time frame: Baseline

  13. Urinalysis

    Time frame: 12 weeks

  14. Electrocardiogram (ECG)

    Time frame: Baseline

  15. Electrocardiogram (ECG)

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Soonchunhyang University Hospital

Other

Collaborators

  • Pfizer

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Sep 10, 2010
Registry last updated
Nov 19, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.