Ziprasidone in Pediatric Bipolar Disorder

Baylor College of Medicine

Status and phase

Completed

Phase 4

Conditions

Bipolar Disorder

Treatments

Drug: Ziprasidone

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00622739

SaxenaZiprasidone

Details and patient eligibility

About

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.

Full 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.

Enrollment

28 patients

Sex

All

Ages

10 to 17 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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.

Exclusion criteria

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