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A Study of the Safety and Tolerability of Oral Ziprasidone in Children and Teens With Psychotic Disorders

Last updated on August 9, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
San Diego, California, 92111 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Schizophrenia, Bipolar Disorder, Schizoaffective Disorder
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
10-17 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Children and teens with Bipolar I Disorder (manic or mixed), schizophrenia or
schizoaffective disorder

- Willingness to discontinue all antipsychotic medications during the study period

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

- Patients who are clinically stable on treatments that are well tolerated

- Substance-induced psychotic disorders

NCT00650611
Pfizer
Completed
A Study of the Safety and Tolerability of Oral Ziprasidone in Children and Teens With Psychotic Disorders

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A Study of the Safety and Tolerability of Oral Ziprasidone in Children and Teens With Psychotic Disorders
A 27-Week Open-Label Trial To Characterize The Safety And Tolerability Of Orally Administered Ziprasidone In Children And Adolescent Subjects With Bipolar I Disorder (Manic Or Mixed), Schizophrenia Or Schizoaffective Disorder
The purpose of this study is to evaluate the safety and tolerability of oral ziprasidone in children and teens with psychotic disorders
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Schizophrenia
  • Bipolar Disorder
  • Schizoaffective Disorder
  • Drug: Ziprasidone

    Period 1: Initial dose of oral ziprasidone suspension 20 mg twice daily, which was titrated up in 20 mg twice daily increments to a maximum dose of 80 mg twice daily by Day 10.

    Period 2: patients could switch to oral capsules or remain on oral suspension; doses were flexibly titrated to between 10 and 80 mg twice daily based on the individual needs of the patient as determined by the investigator; concomitant antidepressants and/or mood stabilizers were allowed during Period 2 but not Period 1.

    Other Name: Geodon, Zeldox
  • Drug: Ziprasidone

    Period 1: Initial dose of oral ziprasidone suspension 10 mg twice daily, which was titrated up in 10 mg twice daily increments to a maximum dose of 40 mg twice daily by Day 10.

    Period 2: patients could switch to oral capsules or remain on oral suspension; doses were flexibly titrated to between 10 and 80 mg twice daily based on the individual needs of the patient as determined by the investigator; concomitant antidepressants and/or mood stabilizers were allowed during Period 2 but not Period 1.

    Other Name: Geodon, Zeldox
  • Active Comparator: Low-Dose Ziprasidone
    Intervention: Drug: Ziprasidone
  • Active Comparator: High-Dose Ziprasidone
    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
63
March 2005
Not Provided

Inclusion Criteria:

  • Children and teens with Bipolar I Disorder (manic or mixed), schizophrenia or schizoaffective disorder
  • Willingness to discontinue all antipsychotic medications during the study period

Exclusion Criteria:

  • Patients who are clinically stable on treatments that are well tolerated
  • Substance-induced psychotic disorders
Sexes Eligible for Study: All
10 Years to 17 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00650611
A1281123
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.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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