Ziprasidone for the Treatment of Mania in Children and Adolescents With Bipolar Disorder
NCT00181922
ABOUT THIS STUDY
FOR MORE INFORMATION
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1. Males and females age 6 to 18 years of age
2. Parent or legal representative must have a level of understanding sufficient to communicate intelligently with the investigator and study coordinator, and to cooperate with all tests and examinations required by the protocol.
3. Patients and their legal representative must be considered reliable.
4. Each patient and his/her authorized legal representative must understand the nature of the study. The patient's authorized legal representative must sign an informed consent document.
5. Patient must have a diagnosis of bipolar I or bipolar II disorder and currently displaying an acute manic, hypomanic, or mixed episode (with or without psychotic features) according to the DSM-IV based on clinical assessment and confirmed by structured diagnostic interview (Kidd Schedule of Affective Disorders).
6. Patients must have an initial score on the Y-MRS total score of at least 15.
7. Patient must be able to participate in mandatory blood draws.
8. Patient must be able to swallow pills.
1. Patients with chronic medical illness, DSM-IV substance dependence within the past 6
months, pregnant or nursing females, and those at serious risk of suicide will be
excluded from the study
2. investigator and his/her immediate family; defined as the investigator's spouse,
parent, child, grandparent, or grandchild.
3. Serious unstable illness including hepatic, renal, gastroenterologic, respiratory,
cardiovascular (including ischemic heart disease), endocrinologic, neurologic,
immunologic, or hematologic disease.
4. Known history of QT prolongation (ie. Congenital long QT syndrome), cardiac
arrhythmia, recent myocardial infarction, or heart failure
5. Concurrent medications known to prolong the QT interval including: antiarrhythmics
(quinidine), antimicrobials and antimalarials (erythromycin, clarithromycin,
ketoconazole, sparfloxacin, moxifloxacin, levofloxacin, gatifloxacin, chloroquine) and
antihistamines (diphenhydramine, hydroxyzine).
6. Known hypokalemia or hypomagnesemia
7. Uncorrected hypothyroidism or hyperthyroidism
8. History of severe allergies or multiple adverse drug reactions
9. Non-febrile seizures without a clear and resolved etiology
10. Leukopenia or history of leucopenia without a clear and resolved etiology
11. DSM-IV substance (except nicotine or caffeine) dependence within the past 6 months
12. Judged clinically to be at serious suicidal risk
13. Any other concomitant medication with primarily central nervous system activity other
than specified in Concomitant Medication portion of the protocol
14. History of intolerance of Ziprasidone as determined by the principal investigator.
15. Treatment with an irreversible monoamine oxidase inhibitor within 2 weeks prior to
visit 2
16. Current diagnosis of schizophrenia
17. For concomitant stimulant therapy used to treat ADHD, patients must have been on a
stable dose of medication for 1 month prior to randomization
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Descriptive Information | ||||
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Brief Title ICMJE | Ziprasidone for the Treatment of Mania in Children and Adolescents With Bipolar Disorder | |||
Official Title ICMJE | Open-Label Study of Ziprasidone for the Treatment of Mania in Children and Adolescents With Bipolar Spectrum Disorder | |||
Brief Summary | The objective of this study is to compare the safety and effectiveness of Ziprasidone in the treatment of mania in children and adolescents with Bipolar disorder over 8 weeks. This is an exploratory, open-label study, which seeks to determine if there is evidence for efficacy. The results of this study will be used to generate hypotheses for a larger study. | |||
Detailed Description | Initial clinical evidence suggests that atypical neuroleptics may play a unique therapeutic role in the management of symptoms in youth with bipolar disorder. Ziprasidone is classed as an atypical neuroleptic because of its unique pharmacological profile that includes both D2 and 5HT2 antagonistic effects. This combined dopaminergic and serotonergic activity seems to be associated not only with antipsychotic effects but also with mood stabilizing, mood elevating and anti-aggressive effects as well as a lower risk for extrapyramidal symptoms and tardive dyskinesia. Ziprasidone in particular has been found to have a higher 5HT2A to D2 receptor affinity ratio, which suggests that the likelihood of extrapyramidal symptoms and hyperprolactinemia may be further decreased. This makes it an ideal candidate to treat mania in children, but although it is used in clinical practice, adequate data has not been collected on its safety and effectiveness. This study included 1) an 8-week acute period, during which participants were observed during weekly visits, and up to a 10-month extension period, during which participants saw a study clinician on a monthly basis, to document the response rate 2) assessment of the impact of Ziprasidone on functional capacities (quality of life, psychosocial function) and cognition, 3) careful assessment of safety and tolerability. | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 4 | |||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
Condition ICMJE |
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Intervention ICMJE | Drug: ziprasidone (Geodon) | |||
Study Arms ICMJE | Not Provided | |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Enrollment ICMJE | 20 | |||
Original Enrollment ICMJE | Same as current | |||
Actual Study Completion Date ICMJE | December 2004 | |||
Primary Completion Date | Not Provided | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
Sex/Gender ICMJE |
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Ages ICMJE | 6 Years to 17 Years (Child) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00181922 | |||
Other Study ID Numbers ICMJE | 2002-p-000183 | |||
Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Joseph Biederman, MD, Massachusetts General Hospital | |||
Study Sponsor ICMJE | Massachusetts General Hospital | |||
Collaborators ICMJE | Pfizer | |||
Investigators ICMJE |
| |||
PRS Account | Massachusetts General Hospital | |||
Verification Date | October 2013 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |