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A Study of the Efficacy and Safety of Ziprasidone for the Treatment of Acute Exacerbation of Schizophrenia or Schizoaffective Disorder

Last updated on October 4, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Monterrey, Nuevo Leon, 64800 Mexico
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Schizophrenia, Schizoaffective Disorder
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-70 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Diagnosis of schizophrenia or schizoaffective disorder.

- Inpatients with acute exacerbation of psychotic symptoms.

- Patients with a minimum score of 40 on the BPRS scale (1-7).

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

- Concurrent treatment with antipsychotic agents at study drug initiation (within 12
hours prior to study drug initiation); for depot agents a period of two weeks or one
cycle, whichever is the longer, must occur between last administration and study drug
initiation.

- Treatment with antidepressants or mood stabilizers within 7 days of start of
ziprasidone.

- Patients currently receiving clozapine.

- Patients at immediate risk of committing harm to self or others.

NCT00650429
Pfizer
Completed
A Study of the Efficacy and Safety of Ziprasidone for the Treatment of Acute Exacerbation of Schizophrenia or Schizoaffective Disorder

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A Study of the Efficacy and Safety of Ziprasidone for the Treatment of Acute Exacerbation of Schizophrenia or Schizoaffective Disorder
Ziprasidone Intramuscular/Oral In The Treatment Of Acute Exacerbation Of Schizophrenia Or Schizoaffective Disorder: A Six-Week Open Administration Study
This study was conducted to examine the efficacy and tolerability of ziprasidone intramuscular (IM), and to assess the effect of switching from IM to oral ziprasidone for the treatment of acute exacerbation of schizophrenia and schizoaffective disorder in a Latin American population.
Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Schizophrenia
  • Schizoaffective Disorder
Drug: Ziprasidone
IM ziprasidone at an initial dose of 10 or 20 mg for the first 3 days; additional doses could be administered according to clinical need, with the maximum total daily IM dose of 40 mg. On Day 4, IM treatment was switched to oral (PO) treatment at an initial dose of 40 mg twice daily for the first 2 days; doses could be subsequently adjusted within the range of 40 to 80 mg twice daily. Total treatment duration was 6 weeks.
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
28
May 2005
Not Provided

Inclusion Criteria:

  • Diagnosis of schizophrenia or schizoaffective disorder.
  • Inpatients with acute exacerbation of psychotic symptoms.
  • Patients with a minimum score of 40 on the BPRS scale (1-7).

Exclusion Criteria:

  • Concurrent treatment with antipsychotic agents at study drug initiation (within 12 hours prior to study drug initiation); for depot agents a period of two weeks or one cycle, whichever is the longer, must occur between last administration and study drug initiation.
  • Treatment with antidepressants or mood stabilizers within 7 days of start of ziprasidone.
  • Patients currently receiving clozapine.
  • Patients at immediate risk of committing harm to self or others.
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Mexico
 
 
NCT00650429
A1281056
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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