Clinical Effect Of Cross Titration Of Antipsychotics With Ziprasidone In Schizophrenia Or Schizoaffective Disorder

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.294 enrolled

Overview

The primary objective is to compare effectiveness of ziprasidone treatment to current treatments (haloperidol, olanzapine or risperidone) measured by change in Brief Psychiatric Rating Scale (BPRS) scores versus baseline

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

294

Conditions

Schizophrenia Psychotic Disorders

Interventions

ziprasidoneDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Primary diagnosis of schizophrenia or schizoaffective disorder, using DSM-IV criteria. * Currently receiving either haloperidol, olanzapine or risperidone within -/+ 25% of the recommended daily dose (as delineated by the medication's package insert Exclusion Criteria: * Resistance to conventional antipsychotic drugs * With antipsychotic agents other than olanzapine, risperidone or haloperidol at start of treatment regimen within 12 hours prior to first dose of study drug

Locations (27)

Pfizer Investigational Site

Alexandria, Egypt

Outcomes

Primary Outcomes

The primary efficacy variable will be change from baseline in Brief Psychiatric Rating Scale (BPRS) total score

Secondary Outcomes

Change From Baseline In Clinical Global Impression Severity (CGI-S)

Clinical Global Impression Improvement (CGI-I)

Change From Baseline In Positive and Negative Syndrome Scale (PANSS) Total

Change from baseline in scores on the Montgomery-Asberg Depression Rating Scale (MADRS)

Change from baseline in scores on the MADRS Without Items 4, 5

Change from baseline in Global Assessment of Functioning (GAF)

Change From Baseline In Drug Attitude Inventory (DAI)

Change From Baseline In Weight

Change From Baseline In Prolactin And Lipid Levels

Change From Baseline in Modified Simpson Angus Scale (m-SAS) Total Score

Change From Baseline in Barnes Akathisia Scale (BAS)

Change From Baseline in Abnormal Involuntary Movement Scale (AIMS)- Movement Ratings Total Score

Change From Baseline in Abnormal Involuntary Movement Scale (AIMS)- Global Judgment Of Severity Total Score

Data from ClinicalTrials.gov

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