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

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NCT00644800

Last updated on October 4, 2018
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FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Salvador, Bahia, 41180-000 Brazil
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Schizophrenia, Mania, Delusional Disorder, Acute Exacerbation of Psychosis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT00644800
Pfizer
Completed
A Study of the Efficacy and Safety of Intramuscular Ziprasidone Followed by Oral Ziprasidone for the Treatment of Psychosis

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A Study of the Efficacy and Safety of Intramuscular Ziprasidone Followed by Oral Ziprasidone for the Treatment of Psychosis
An Open, Multicenter, Non-Comparative Study To Assess The Efficacy And Tolerability Of Intramuscular Ziprasidone Followed By Oral Ziprasidone In Patients With Acute Psychosis
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.
Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Schizophrenia
  • Mania
  • Delusional Disorder
  • Acute Exacerbation of Psychosis
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
Experimental: Arm A
Intervention: Drug: Ziprasidone
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
89
May 2004
Not Provided

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.
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
 
NCT00644800
A1281074
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
April 2008

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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[email protected]



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