CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 255 enrolled
Drug / intervention
ziprasidonedrug
Likely dose
ziprasidone 40 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00406315
NCT00406315Phase 4Completed

A Sixteen-Week, Multi-Center, Open-Label Study Evaluating The Safety, Tolerability, And Efficacy Of Switching From Quetiapine To Ziprasidone In Subjects Diagnosed With Schizophrenia Or Schizoaffective Disorder

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.·interventional·Posted Dec 4, 2006·Updated Mar 29, 2021

In Brief

A Phase 4 clinical trial evaluating ziprasidone for Schizophrenia and Schizoaffective Disorder. Completed, enrolled 255 participants across 40 sites in 6 countries.

Detailed Summary

The primary objective of this study is to evaluate change in weight as a result of switching from quetiapine to ziprasidone, in subjects with schizophrenia or schizoaffective disorder who have failed to achieve a satisfactory clinical response to quetiapine due to lack of efficacy or poor tolerability.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBrazil, Germany, Greece, Spain, Turkey (Türkiye), United States
Collaborators--

Timeline

Phase 4CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 4, 2006
Enrollment StartNov 1, 2006
Primary CompletionDec 1, 2008
Study CompletionMar 1, 2009
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 19.6 years ago

Interventions

ziprasidonedrug

Days 1-3: 40 mg twice a day (BID); Days 4-7: 60 mg BID; Day 8: 80 mg BID; Flexible dose between 40-80 mg BID (adjustable up to 40 mg daily/week) for the remainder of the 16-week treatment phase and continuing throughout the 16-week follow-up phase