A Study of the Efficacy and Safety of Ziprasidone in Patients With Acute Exacerbation of Schizophrenia or Schizoaffective Disorder

Efficacy And Safety Of Ziprasidone In Acute Exacerbation Of Schizophrenia Or Schizoaffective Disorder, Including Patients With A Diagnosis Of Recent Onset

The purpose of this study is to evaluate the efficacy and safety of ziprasidone in acute exacerbation of schizophrenia or schizoaffective disorder, including patients with recent onset of symptoms

Study Overview

• Status: Terminated
• Conditions: Schizophrenia; Schizoaffective Disorder
• Intervention / Treatment: Drug: Ziprasidone

Detailed Description

The study was prematurely discontinued due to the difficulty of subject recruitment on March 24, 2005. There were no safety concerns that led to the decision to terminate.

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Phase 3

Contacts and Locations

Study Locations

• Portugal
  • Lisboa, Portugal, 1600-219
    • Pfizer Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients not currently being treated with antipsychotic medication and neuroleptic naive patients
• Diagnosis of schizophrenia or schizoaffective disorder
• Antipsychotic treatment prior to screening was to be for a cumulative period of less than 5 years

Exclusion Criteria:

• Patients at immediate risk of committing harm to self or others
• Treatment with clozapine within 3 months prior to baseline
• History of neuroleptic treatment
• Current antipsychotic treatment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Arm A	Drug: Ziprasidone; Ziprasidone 20 mg capsules twice daily on Days 1-3; dose could be increased if clinically indicated up to 80 mg twice daily; total treatment duration was to be 24 weeks; Other Names: Geodon, Zeldox

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in Positive and Negative Syndrome Scale (PANSS) total score at Week 24	Week 24
Change from baseline in PANSS (Depression-C) score at Week 24	Week 24
Change from baseline in Clinical Global Impressions-Severity (CGI-S) total score at Week 24	Week 24
Change from baseline in CGI-S total score at Week 24	Week 24

Secondary Outcome Measures

Outcome Measure	Time Frame
Vital signs and weight at screening, baseline, Day 3, Week 1, and Months 1, 2, 3, 4, 5, and 6	Screening, baseline, Day 3, Week 1, and Months 1, 2, 3, 4, 5, and 6
Change from baseline in Clinical Global Impressions-Improvement (CGI-I) score at Week 24	Week 24
Adverse events on Day 3, Week 1, and Months 1, 2, 3, 4, 5, and 6	Day 3, Week 1, and Months 1, 2, 3, 4, 5, and 6
Change from baseline in Global Assessment of Functioning (GAF) score at Week 24	Week 24
Laboratory parameters at screening, baseline, Day 3, Week 1, and Months 1, 2, 3, 4, 5, and 6	Screening, baseline, Day 3, Week 1, and Months 1, 2, 3, 4, 5, and 6
Simpson-Angus Scale (SAS) at screening, baseline, Day 3, Week 1, and Months 1, 2, 3, 4, 5, and 6	Screening, baseline, Day 3, Week 1, and Months 1, 2, 3, 4, 5, and 6
Barnes Akathisia Scale (BAS) at screening, baseline, Day 3, Week 1, and Months 1, 2, 3, 4, 5, and 6	Screening, baseline, Day 3, Week 1, and Months 1, 2, 3, 4, 5, and 6
Electrocardiogram	Screening and Month 4

Collaborators and Investigators

• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: September 1, 2004
• Study Completion (ACTUAL): March 1, 2005

Study Registration Dates

• First Submitted: March 25, 2008
• First Submitted That Met QC Criteria: March 25, 2008
• First Posted (ESTIMATE): March 27, 2008

Study Record Updates

• Last Update Posted (ACTUAL): February 21, 2021
• Last Update Submitted That Met QC Criteria: February 18, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Psychotic Disorders; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Agents; Dopamine Agents; Serotonin Antagonists; Dopamine Antagonists; Ziprasidone
• Other Study ID Numbers: A1281055