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

This study has been terminated.
(Please see Detailed Description for termination reason.)
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00645229
First received: March 25, 2008
Last updated: April 7, 2008
Last verified: April 2008
  Purpose

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


Condition Intervention Phase
Schizophrenia
Schizoaffective Disorder
Drug: Ziprasidone
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy And Safety Of Ziprasidone In Acute Exacerbation Of Schizophrenia Or Schizoaffective Disorder, Including Patients With A Diagnosis Of Recent Onset

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Change from baseline in Positive and Negative Syndrome Scale (PANSS) total score at Week 24 [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
  • Change from baseline in PANSS (Depression-C) score at Week 24 [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
  • Change from baseline in Clinical Global Impressions-Severity (CGI-S) total score at Week 24 [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
  • Change from baseline in CGI-S total score at Week 24 [ Time Frame: Week 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Vital signs and weight at screening, baseline, Day 3, Week 1, and Months 1, 2, 3, 4, 5, and 6 [ Time Frame: Screening, baseline, Day 3, Week 1, and Months 1, 2, 3, 4, 5, and 6 ] [ Designated as safety issue: Yes ]
  • Change from baseline in Clinical Global Impressions-Improvement (CGI-I) score at Week 24 [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
  • Adverse events on Day 3, Week 1, and Months 1, 2, 3, 4, 5, and 6 [ Time Frame: Day 3, Week 1, and Months 1, 2, 3, 4, 5, and 6 ] [ Designated as safety issue: Yes ]
  • Change from baseline in Global Assessment of Functioning (GAF) score at Week 24 [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
  • Laboratory parameters at screening, baseline, Day 3, Week 1, and Months 1, 2, 3, 4, 5, and 6 [ Time Frame: Screening, baseline, Day 3, Week 1, and Months 1, 2, 3, 4, 5, and 6 ] [ Designated as safety issue: Yes ]
  • Simpson-Angus Scale (SAS) at screening, baseline, Day 3, Week 1, and Months 1, 2, 3, 4, 5, and 6 [ Time Frame: Screening, baseline, Day 3, Week 1, and Months 1, 2, 3, 4, 5, and 6 ] [ Designated as safety issue: Yes ]
  • Barnes Akathisia Scale (BAS) at screening, baseline, Day 3, Week 1, and Months 1, 2, 3, 4, 5, and 6 [ Time Frame: Screening, baseline, Day 3, Week 1, and Months 1, 2, 3, 4, 5, and 6 ] [ Designated as safety issue: Yes ]
  • Electrocardiogram [ Time Frame: Screening and Month 4 ] [ Designated as safety issue: Yes ]

Enrollment: 1
Study Start Date: September 2004
Study Completion Date: March 2005
Arms Assigned Interventions
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 Name: Geodon, Zeldox

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00645229

Locations
Portugal
Pfizer Investigational Site
Lisboa, Portugal, 1600-219
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00645229     History of Changes
Other Study ID Numbers: A1281055
Study First Received: March 25, 2008
Last Updated: April 7, 2008
Health Authority: Portugal: National Authority for Drug and Medicine

Additional relevant MeSH terms:
Psychotic Disorders
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Ziprasidone
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents

ClinicalTrials.gov processed this record on August 18, 2014