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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00644800
Recruitment Status : Completed
First Posted : March 27, 2008
Last Update Posted : April 10, 2008
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Brief Summary:
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 or disease Intervention/treatment Phase
Schizophrenia Mania Delusional Disorder Acute Exacerbation of Psychosis Drug: Ziprasidone Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 89 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : July 2003
Actual Study Completion Date : May 2004

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Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Change from baseline in Positive and Negative Syndrome Scale (PANSS) excitation items scores [ Time Frame: Days 1-3 (end of intramuscular dosing) ]

Secondary Outcome Measures :
  1. Electrocardiogram at Visits 1 and 5 [ Time Frame: Visits 1 (Screening) and 5 (Day 7) ]
  2. 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) ]
  3. 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) ]
  4. Laboratory tests at Visits 1 and 5 [ Time Frame: Visits 1 (Screening) and 5 (Day 7) ]
  5. 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) ]
  6. 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) ]
  7. Blood pressure and pulse at Visits 1, 2, and 5 [ Time Frame: Visits 1 (Screening), 2 (Day 1), and 5 (Day 7) ]
  8. 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) ]

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00644800

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
Study Director: Pfizer Call Center Pfizer

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc. Identifier: NCT00644800     History of Changes
Other Study ID Numbers: A1281074
First Posted: March 27, 2008    Key Record Dates
Last Update Posted: April 10, 2008
Last Verified: April 2008

Additional relevant MeSH terms:
Psychotic Disorders
Mental Disorders
Schizophrenia, Paranoid
Schizophrenia Spectrum and Other Psychotic Disorders
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents