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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00650611
First received: March 28, 2008
Last updated: April 7, 2008
Last verified: April 2008

March 28, 2008
April 7, 2008
December 2003
Not Provided
  • Adverse events at Baseline, Day 4, and Weeks 1, 2, 3, 4, 8, 12, 18, and 27. [ Time Frame: 27 weeks ] [ Designated as safety issue: Yes ]
  • Electrocardiograms and vital signs at Screening, baseline, Day 4, and Weeks 1, 2, 3, 4, 8, 12, 18, and 27. [ Time Frame: 27 weeks ] [ Designated as safety issue: Yes ]
  • Laboratory data at Screening and Weeks 3, 12, and 27. [ Time Frame: 27 weeks ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00650611 on ClinicalTrials.gov Archive Site
  • Clinical Global Impressions-Improvement (CGI-I) scale scores on Day 4 and at Weeks 1, 2, and 3. [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
  • Mean change from baseline in Childrens' Global Assessment Scale (CGAS) scores on Day 4 and at Weeks 1, 2, 3, 12, and 27. [ Time Frame: 27 weeks ] [ Designated as safety issue: No ]
  • Serum concentrations of ziprasidone and its major metabolites at Weeks 1, 3, 12, and 27. [ Time Frame: 27 weeks ] [ Designated as safety issue: No ]
  • Mean change from baseline in Clinical Global Impressions-Severity (CGI-S) scale scores on Day 4 and at Weeks 1, 2, 3, 12, and 27. [ Time Frame: 27 weeks ] [ Designated as safety issue: No ]
  • Mean change from baseline in Young Mania Rating Scale (YMRS) scores on Day 4 and at Weeks 1, 2, 3, 12, and 27. [ Time Frame: 27 weeks ] [ Designated as safety issue: No ]
  • Mean change from baseline in Brief Psychiatric Rating Scale-Anchored (BPRS-A) scores on Day 4 and at Weeks 1, 2, 3, 12, and 27. [ Time Frame: 27 weeks ] [ Designated as safety issue: No ]
  • Mean change from baseline in movement disorder rating scale scores at Weeks 3, 12, and 27. [ Time Frame: 27 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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
Both
10 Years to 17 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00650611
A1281123
No
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