Status:
COMPLETED
Ziprasidone for the Treatment of Mania in Children and Adolescents With Bipolar Disorder
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
Pfizer
Conditions:
Bipolar Disorder
Mania
Eligibility:
All Genders
6-17 years
Phase:
PHASE4
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, ...
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 neu...
Eligibility Criteria
Inclusion
- Males and females age 6 to 18 years of age
- 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.
- Patients and their legal representative must be considered reliable.
- 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.
- 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).
- Patients must have an initial score on the Y-MRS total score of at least 15.
- Patient must be able to participate in mandatory blood draws.
- Patient must be able to swallow pills.
Exclusion
- 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
- investigator and his/her immediate family; defined as the investigator's spouse, parent, child, grandparent, or grandchild.
- Serious unstable illness including hepatic, renal, gastroenterologic, respiratory, cardiovascular (including ischemic heart disease), endocrinologic, neurologic, immunologic, or hematologic disease.
- Known history of QT prolongation (ie. Congenital long QT syndrome), cardiac arrhythmia, recent myocardial infarction, or heart failure
- 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).
- Known hypokalemia or hypomagnesemia
- Uncorrected hypothyroidism or hyperthyroidism
- History of severe allergies or multiple adverse drug reactions
- Non-febrile seizures without a clear and resolved etiology
- Leukopenia or history of leucopenia without a clear and resolved etiology
- DSM-IV substance (except nicotine or caffeine) dependence within the past 6 months
- Judged clinically to be at serious suicidal risk
- Any other concomitant medication with primarily central nervous system activity other than specified in Concomitant Medication portion of the protocol
- History of intolerance of Ziprasidone as determined by the principal investigator.
- Treatment with an irreversible monoamine oxidase inhibitor within 2 weeks prior to visit 2
- Current diagnosis of schizophrenia
- For concomitant stimulant therapy used to treat ADHD, patients must have been on a stable dose of medication for 1 month prior to randomization
Key Trial Info
Start Date :
March 1 2002
Trial Type :
INTERVENTIONAL
End Date :
December 1 2004
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00181922
Start Date
March 1 2002
End Date
December 1 2004
Last Update
October 22 2013
Active Locations (2)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
2
Massachusetts General Hospital
Cambridge, Massachusetts, United States, 02138