Ziprasidone in Pediatric Bipolar Disorder
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Intervention: Ziprasidone; Ziprasidone
Intervention description: Subjects will be treated openly with Ziprasidone for 6 weeks. Dose will be titrated from 20 mg to a maximum of 160 mg. Arm 1 will have the dose of Ziprasidone titrated at a rate of 20 mg every 2 days, reaching the maximum dose in 14 days. Final dose of Ziprasidone will be determined by symptoms reduction and the presence or absence of side effects.; Subjects will be treated openly with Ziprasidone for 6 weeks. Dose will be titrated from 20mg to a maximum of 160mg. Arm 2 will have the dose of Ziprasidone titrated at a rate of 20mg every 3-4 days, reaching the maximum dose in 25 days. Final dose of Ziprasidone will be determined by symptoms reduction and the presence or absence of side effects.
Intervention MeSH terms: Ziprasidone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 28.0
Sex: All
Minimum age: 10 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Bipolar Disorder; Children; Adolescents; Treatment

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.
    

Eligibility criteria:

        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