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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ziprasidone oral capsules | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | weeks 1, 2, 6, 10, 14, 18, 22, and 26 | |
| Change from baseline in Physical exam | week 26 | |
| Change from baseline in Clinical laboratory tests | weeks 2, 6, 18,26 | |
| Change from baseline in body weight, height, BMI, BMI z score, and waist circumference | weeks 6, 26 | |
| 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) | weeks 1, 2, 6, 10, 14, 18, 22, and 26 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Young Mania Rating Scale (YMRS) | weeks 2, 6, 18, and 26 | |
| Change from Baseline in Children's Problem Behavior and Aggression Questionnaire (CPBAQ) | weeks 2, 6, 18, and 26 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| Change from Baseline in Child Health Questionnaire |
| weeks 6 and 26 |
| Change from Baseline in School Placement Questionnaire | weeks 6 and 26 |
| Change from Baseline in CNS Vital Signs Cognitive Test Battery | weeks 6 and 26 |
| Change from Baseline in CNS Vital Signs Cognitive Test Sedation Item | weeks 6 and 26 |
| Change from Baseline in Simpson-Angus Rating Scale (SARS) | weeks 1, 2, 6, 10, 14, 18, 22 and 26 |
| Change from Baseline in Barnes Akathisia Rating Scale (BAS) | weeks 1, 2, 6, 10, 14, 18, 22 and 26 |
| Change from Baseline in Abnormal Involuntary Movement Scale (AIMS) | weeks 1, 2, 6, 10, 14, 18, 22 and 26 |
| Change from Baseline in Childrens Global Assessment Scales | weeks 2, 6, 18, and 26 |
| Change from Baseline in Tanner Adolescent Pubertal Self-Assessment | 26 weeks |
| ID | Term |
|---|---|
| D001714 | Bipolar Disorder |
| D000087122 | Mania |
| ID | Term |
|---|---|
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C092292 | ziprasidone |
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