Ziprasidone for the Treatment of Mania in Children and Adolescents With Bipolar Disorder

Completed · Phase 4

Conditions studied: Bipolar Disorder, Mania

In brief

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.

Key facts

Study ID: NCT00181922
Run by: Massachusetts General Hospital
People needed: 20
Starts: 2002-03-01
Expected to finish: 2004-12-01
Last updated by the study team: 2013-10-22

Who can join

Age: 6 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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

Where it is running

Massachusetts General Hospital — Boston, Massachusetts, United States
Massachusetts General Hospital — Cambridge, Massachusetts, United States

Full record on ClinicalTrials.gov

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