Safety And Tolerability Of Flexible Doses Of Oral Ziprasidone In Children And Adolescents With Bipolar I Disorder (Manic Or Mixed)
This study has been withdrawn prior to enrollment.
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01124877
First received: May 14, 2010
Last updated: January 17, 2013
Last verified: January 2013
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Purpose
The purpose of this study is to assess the safety and tolerability of ziprasidone during a long-term open label study in children and adolescents (ages 10-17) with Bipolar I Disorder (Manic or Mixed).
| Condition | Intervention | Phase |
|---|---|---|
|
Bipolar Disorder |
Drug: ziprasidone oral capsules |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | 26 Week Open Label Extension Study Evaluating The Safety And Tolerability Of Flexible Doses Of Oral Ziprasidone In Children And Adolescents With Bipolar I Disorder (Manic Or Mixed) |
Resource links provided by NLM:
Further study details as provided by Pfizer:
Primary Outcome Measures:
- Change from Baseline in blood pressure and pulse Change from baseline in electrocardiogram (QTc) Change from Baseline in Clinical Global Impression of Severity Scale (CGI-S) [ Time Frame: weeks 1, 2, 6, 10, 14, 18, 22, and 26 ] [ Designated as safety issue: Yes ]
- Change from baseline in Physical exam [ Time Frame: week 26 ] [ Designated as safety issue: Yes ]
- Change from baseline in Clinical laboratory tests [ Time Frame: weeks 2, 6, 18,26 ] [ Designated as safety issue: Yes ]
- Change from baseline in body weight, height, BMI, BMI z score, and waist circumference [ Time Frame: weeks 6, 26 ] [ Designated as safety issue: Yes ]
- Adverse events -Only number of subjects with adverse events or serious adverse events Columbia Suicide Severity Rating Scale Change from Baseline in Child Depression Rating Scale - Revised (CDRS-R) [ Time Frame: weeks 1, 2, 6, 10, 14, 18, 22, and 26 ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Change from Baseline in Young Mania Rating Scale (YMRS) [ Time Frame: weeks 2, 6, 18, and 26 ] [ Designated as safety issue: No ]
- Change from Baseline in Children's Problem Behavior and Aggression Questionnaire (CPBAQ) [ Time Frame: weeks 2, 6, 18, and 26 ] [ Designated as safety issue: No ]
- Change from Baseline in Child Health Questionnaire [ Time Frame: weeks 6 and 26 ] [ Designated as safety issue: No ]
- Change from Baseline in School Placement Questionnaire [ Time Frame: weeks 6 and 26 ] [ Designated as safety issue: No ]
- Change from Baseline in CNS Vital Signs Cognitive Test Battery [ Time Frame: weeks 6 and 26 ] [ Designated as safety issue: No ]
- Change from Baseline in CNS Vital Signs Cognitive Test Sedation Item [ Time Frame: weeks 6 and 26 ] [ Designated as safety issue: No ]
- Change from Baseline in Simpson-Angus Rating Scale (SARS) [ Time Frame: weeks 1, 2, 6, 10, 14, 18, 22 and 26 ] [ Designated as safety issue: No ]
- Change from Baseline in Barnes Akathisia Rating Scale (BAS) [ Time Frame: weeks 1, 2, 6, 10, 14, 18, 22 and 26 ] [ Designated as safety issue: No ]
- Change from Baseline in Abnormal Involuntary Movement Scale (AIMS) [ Time Frame: weeks 1, 2, 6, 10, 14, 18, 22 and 26 ] [ Designated as safety issue: No ]
- Change from Baseline in Childrens Global Assessment Scales [ Time Frame: weeks 2, 6, 18, and 26 ] [ Designated as safety issue: No ]
- Change from Baseline in Tanner Adolescent Pubertal Self-Assessment [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 0 |
| Study Start Date: | July 2010 |
| Estimated Study Completion Date: | October 2011 |
| Estimated Primary Completion Date: | October 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Open |
Drug: ziprasidone oral capsules
Oral ziprasidone capsules of 20 mg, 40 mg, 60 mg, and 80 mg strength will be provided. Subjects will be dosed daily for 26 weeks using a flexible dose design with a minimal dose range of 40mg twice a day (BID) to a maximum dose range of 80 mg BID. For subjects weighing <45 kg, the doses will range from 20 mg BID to 40 mg BID.
Other Name: Zeldox, Geodon
|
Eligibility| Ages Eligible for Study: | 10 Years to 17 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- The subjects must have received study medication in Study A1281196.
- In the investigator's opinion, the subject must be likely to continue to benefit from antipsychotic therapy and must have been free from any clinically significant safety concerns during the preceding double blind study.
Exclusion Criteria:
- Subjects who require treatment with drugs that are known to consistently prolong the QT interval.
- Subjects who are judged by the investigator as being at imminent risk of suicide.
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT01124877 History of Changes |
| Other Study ID Numbers: | A1281197 |
| Study First Received: | May 14, 2010 |
| Last Updated: | January 17, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Pfizer:
|
Children and Adolescents with Bipolar I Disorder (manic or mixed) |
Additional relevant MeSH terms:
|
Bipolar Disorder Affective Disorders, Psychotic Mood Disorders Mental Disorders 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 May 22, 2013