A Study of the Efficacy and Safety of Intramuscular Ziprasidone Followed by Oral Ziprasidone for the Treatment of Psychosis

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00644800
First received: March 20, 2008
Last updated: April 7, 2008
Last verified: April 2008
  Purpose

To assess the efficacy, safety, and tolerability of intramuscular ziprasidone in the treatment of the acute exacerbation of non-organic psychosis of any etiology, including schizophrenia, acute mania, delusional disorder and others.


Condition Intervention Phase
Schizophrenia
Mania
Delusional Disorder
Acute Exacerbation of Psychosis
Drug: Ziprasidone
Phase 4

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: An Open, Multicenter, Non-Comparative Study To Assess The Efficacy And Tolerability Of Intramuscular Ziprasidone Followed By Oral Ziprasidone In Patients With Acute Psychosis

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) excitation items scores [ Time Frame: Days 1-3 (end of intramuscular dosing) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Electrocardiogram at Visits 1 and 5 [ Time Frame: Visits 1 (Screening) and 5 (Day 7) ] [ Designated as safety issue: Yes ]
  • Adverse events at Visits 2, 3, 4, and 5 [ Time Frame: Visits 2 (Day 1), 3 (Day 1, 2, 3, or 4), 4 (Day 5), and 5 (Day 7) ] [ Designated as safety issue: Yes ]
  • Change from baseline in Patient Preference Scale (PPS) scores at Visits 3 and 5 [ Time Frame: Visits 2 (Day 1), 3 (Day 1, 2, 3, or 4) and 5 (Day 7) ] [ Designated as safety issue: No ]
  • Laboratory tests at Visits 1 and 5 [ Time Frame: Visits 1 (Screening) and 5 (Day 7) ] [ Designated as safety issue: Yes ]
  • Movement disorder rating scale scores (Barnes Akathisia Scale and Extrapyramidal Symptoms Rating Scale) at Visits 2, 3, 4, and 5 [ Time Frame: Visits 2 (Day 1), 3 (Day 1, 2, 3, or 4), 4 (Day 5), and 5 (Day 7) ] [ Designated as safety issue: Yes ]
  • Change from baseline in PANSS excitation items scores at Visits 3, 4, and 5 [ Time Frame: Visits 1 (Screening), 2 (Day 1), 3 (Day 1, 2, 3, or 4), 4 (Day 5), and 5 (Day 7) ] [ Designated as safety issue: No ]
  • Blood pressure and pulse at Visits 1, 2, and 5 [ Time Frame: Visits 1 (Screening), 2 (Day 1), and 5 (Day 7) ] [ Designated as safety issue: Yes ]
  • Change from baseline in Clinical Global Impression-Severity (CGI-S) scores at Visits 3, 4, and 5 [ Time Frame: Visits 1 (Screening), 2 (Day 1), 3 (Day 1, 2, 3, or 4), 4 (Day 5), and 5 (Day 7) ] [ Designated as safety issue: No ]

Enrollment: 89
Study Start Date: July 2003
Study Completion Date: May 2004
Arms Assigned Interventions
Experimental: Arm A Drug: Ziprasidone
Intramuscular ziprasidone 10 or 20 mg at the investigator's discretion for 1 to 3 days followed by oral ziprasidone capsules 40 to 80 mg twice daily at the investigator's discretion to complete 7 days of treatment
Other Name: Geodon, Zeldox

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Hospitalized patients with psychosis
  • Eligible for intramuscular treatment
  • Miminum score of 60 on the PANSS, a score of 14 in the sum of PANSS excitation score and a score of at least 4 in 1 of the following items: poor control of impulses, tension, hostility, uncooperativeness or excitation.

Exclusion Criteria:

  • Treatment with antidepressants or mood stabilizers within seven days prior to the enrollment; for monoamine oxidase inhibitors (MAOIs) and moclobemide, this period must be two weeks; for fluoxetine, five weeks
  • Resistance to conventional antipsychotic agents
  • A history of epilepsy
  • A diagnosis of abuse of substance within the previous 3 months according to the DSMIV criteria.
  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: NCT00644800

Locations
Brazil
Pfizer Investigational Site
Salvador, Bahia, Brazil, 41180-000
Pfizer Investigational Site
Fortaleza, Ceara, Brazil, 60175-270
Pfizer Investigational Site
Belo Horizonte, MG, Brazil, 30150-270
Pfizer Investigational Site
Curitiba, PR, Brazil
Pfizer Investigational Site
Rio de Janeiro, RJ, Brazil
Pfizer Investigational Site
Sao Goncalo, RJ, Brazil
Pfizer Investigational Site
Jardim Santa Monica Sn, Salvador - Ba, Brazil, 40340-720
Pfizer Investigational Site
Sao Paulo, SP, Brazil
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: NCT00644800     History of Changes
Other Study ID Numbers: A1281074
Study First Received: March 20, 2008
Last Updated: April 7, 2008
Health Authority: Brazil: National Health Surveillance Agency

Additional relevant MeSH terms:
Schizophrenia, Paranoid
Delusions
Mental Disorders
Psychotic Disorders
Schizophrenia
Bipolar Disorder
Schizophrenia and Disorders with Psychotic Features
Behavioral Symptoms
Affective Disorders, Psychotic
Mood 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 July 29, 2014