ABOUT THIS STUDY
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- Outpatients aged 10-17 years
- Currently meet Diagnostic and Statistical Manual of Mental Disorders IV-Text Revision (DSM-IV-TR) criteria for bipolar disorder, type I, II or Not Otherwise Specified (NOS) as determined by the Schedule for Affective Disorders and Schizophrenia -Present/Lifetime (Kiddie-SADS-PL)
- Experiencing manic, hypomanic or mixed states as determined by clinical diagnosis and Kiddie- Young Mania rating scale (K-YMRS) equal to or more than 14
- General good health as determined by medical history, physical examination, and laboratory evaluations
- Female adolescents, if sexually active, must practice birth control methods approved by the primary investigator
- Ability to swallow tablets
- Subject's parent or guardian must be fully capable of monitoring the subject's disease process and compliance to treatment
- Parent(s) or legal guardian(s) must read and sign the informed consent form after the nature of the study has been fully explained and assent must be obtained from subjects.
- Have a lifetime DSM-IV-TR Axis I disorder diagnosis of autistic disorder,
schizophrenia, schizoaffective disorder, or other psychotic disorders
- DSM-IV-TR diagnosis of alcohol or substance abuse or dependence within the past 6
months
- Serious or unstable medical or neurological conditions which require concomitant
medications
- Judged by the principal investigator (PI) to be acutely suicidal or homicidal, or at
imminent risk of injuring self or others or causing significant damage to
property-i.e., subject needs to be in an inpatient facility
- Known or suspected intelligence quotient (IQ) less than 70
- Have a DSM-IV-TR diagnosis of anorexia and/or bulimia at the time of screening or
within the last six months
- Female who is pregnant or nursing
- Subjects with a history of syncopal episodes (sudden loss of consciousness with loss
of postural tone and not preceded by a pre-syncopal phase) or unexplained loss of
consciousness
- Subjects with a history of significant cardiovascular disease or significant
concurrent cardiovascular disease, including uncontrolled hypertension, hypotension,
congestive heart failure or congenital heart disease
- Subjects with a history of cardiac arrhythmias, conduction abnormalities or known
personal history or corrected QT prolongation (including congenital long QT syndrome)
- Subjects with a known genetic risk for QT syndrome determined by family history in
first degree relatives
- Subjects taking any medications known to interact with ziprasidone or subjects taking
any medications which have been consistently observed to prolong the QT interval
- Subjects with a clinically significant ECG abnormality at screening
- Subjects with persistent QTc (Fridericia) * 460 msec at screening
- Screening laboratory values outside the normal range and judged to be clinically
significant by the investigator
- Patients and families that are Spanish speaking only will be excluded from the study
as some instruments used in the study have not been validated in Spanish
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Descriptive Information | ||||
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Brief Title ICMJE | Ziprasidone in Pediatric Bipolar Disorder | |||
Official Title ICMJE | Ziprasidone in Pediatric Bipolar Disorder: a 6-week, Open-label Comparison of Rapid vs. Slow Dose Titration | |||
Brief Summary | This is a 6 week, open-label, blinded-rater, randomized, controlled, pilot study designed to determine the dosing, safety and efficacy of ziprasidone in the treatment of pediatric bipolar disorder (PBD). In this pilot study we are comparing the efficacy of rapid versus slow dose titration of ziprasidone in PBD. The investigators hypothesize that subjects on ziprasidone monotherapy will have a reduction in manic symptoms. Also, the investigators hypothesize that slower titration of ziprasidone will result in lesser side effects which will assist in medication compliance as measured by patient report and pill count. | |||
Detailed Description | This study will enroll approximately 60 children and adolescents aged 10-17 years who have been diagnosed with bipolar disorder. Their participation will last about 8 weeks (2 weeks of screening and 6 weeks of medication management) and enrollment will last for two years. After the screening period, all subjects who meet inclusion/exclusion criteria will be randomized to either rapid or slow dose titration of ziprasidone. Subjects in the rapid titration group will reach their maximum dose of study drug over 2 weeks, subjects in the slow titration group over 4 weeks. The study doctor may deviate from the dosing schedule if clinically indicated. The primary data analysis of this pilot study will examine the effect of rapid- versus slow-dose titration of ziprasidone on manic symptoms. | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 4 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
Condition ICMJE | Bipolar Disorder | |||
Intervention ICMJE |
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Study Arms ICMJE |
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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 | |||
Actual Enrollment ICMJE | 28 | |||
Original Estimated Enrollment ICMJE | 60 | |||
Actual Study Completion Date ICMJE | November 2009 | |||
Actual Primary Completion Date | September 2009 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 10 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 | NCT00622739 | |||
Other Study ID Numbers ICMJE | SaxenaZiprasidone | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Kirti Saxena, Baylor College of Medicine | |||
Study Sponsor ICMJE | Baylor College of Medicine | |||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | Baylor College of Medicine | |||
Verification Date | September 2019 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |