A Study of the Safety and Tolerability of Oral Ziprasidone in Children and Teens With Psychotic Disorders
This study has been completed.
Sponsor:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00650611
First received: March 28, 2008
Last updated: April 7, 2008
Last verified: April 2008
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
The purpose of this study is to evaluate the safety and tolerability of oral ziprasidone in children and teens with psychotic disorders
| Condition | Intervention | Phase |
|---|---|---|
|
Schizophrenia Bipolar Disorder Schizoaffective Disorder |
Drug: Ziprasidone |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | 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 |
Resource links provided by NLM:
MedlinePlus related topics:
Bipolar Disorder
Child Mental Health
Mental Disorders
Psychotic Disorders
Schizophrenia
U.S. FDA Resources
Further study details as provided by Pfizer:
Primary Outcome Measures:
- 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 ]
Secondary Outcome Measures:
- 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 ]
| Enrollment: | 63 |
| Study Start Date: | December 2003 |
| Study Completion Date: | March 2005 |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Low-Dose Ziprasidone |
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: High-Dose Ziprasidone |
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
|
Eligibility| Ages Eligible for Study: | 10 Years to 17 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00650611
Locations
| United States, California | |
| Pfizer Investigational Site | |
| San Diego, California, United States, 92111 | |
| United States, Florida | |
| Pfizer Investigational Site | |
| Altamonte Springs, Florida, United States, 32701 | |
| United States, Illinois | |
| Pfizer Investigational Site | |
| Libertyville, Illinois, United States, 60048 | |
| United States, Kentucky | |
| Pfizer Investigational Site | |
| Lexington, Kentucky, United States, 40509 | |
| United States, Massachusetts | |
| Pfizer Investigational Site | |
| Belmont, Massachusetts, United States, 02478 | |
| Pfizer Investigational Site | |
| Brighton, Massachusetts, United States, 02135 | |
| United States, Nevada | |
| Pfizer Investigational Site | |
| Las Vegas, Nevada, United States, 89103 | |
| Pfizer Investigational Site | |
| Las Vegas, Nevada, United States, 89117 | |
| Pfizer Investigational Site | |
| Las Vegas, Nevada, United States, 89128 | |
| United States, New Jersey | |
| Pfizer Investigational Site | |
| Turnersville, New Jersey, United States, 08012 | |
| United States, Ohio | |
| Pfizer Investigational Site | |
| Cincinnati, Ohio, United States, 45224 | |
| Pfizer Investigational Site | |
| Cincinnati, Ohio, United States, 45229 | |
| Pfizer Investigational Site | |
| Cincinnati, Ohio, United States, 45267-0559 | |
| Pfizer Investigational Site | |
| Cleveland, Ohio, United States, 44106 | |
| United States, Pennsylvania | |
| Pfizer Investigational Site | |
| Philadelphia, Pennsylvania, United States, 19104-3309 | |
| United States, Washington | |
| Pfizer Investigational Site | |
| Kirkland, Washington, United States, 98033 | |
| Pfizer Investigational Site | |
| Kirkland, Washington, United States, 98034 | |
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Director, Clinical Trial Disclosure Group, Pfizer, Inc. |
| ClinicalTrials.gov Identifier: | NCT00650611 History of Changes |
| Other Study ID Numbers: | A1281123 |
| Study First Received: | March 28, 2008 |
| Last Updated: | April 7, 2008 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Bipolar Disorder Psychotic Disorders Schizophrenia Affective Disorders, Psychotic Mood Disorders Mental Disorders Schizophrenia and Disorders with Psychotic Features Ziprasidone Serotonin Antagonists Serotonin Agents Neurotransmitter Agents |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Central Nervous System Agents Therapeutic Uses Psychotropic Drugs Dopamine Antagonists Dopamine Agents |
ClinicalTrials.gov processed this record on June 18, 2013