Ziprasidone in Pediatric Bipolar Disorder

NCT00622739

Last updated date
Study Location
UT Southwestern Medical Center
Dallas, Texas, 75390, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Bipolar Disorder
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
10-17 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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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Advanced Information
Descriptive Information
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
  • Drug: Ziprasidone
    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.
    Other Name: Geodon
  • Drug: Ziprasidone
    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.
    Other Name: Geodon
Study Arms  ICMJE
  • Active Comparator: ziprasidone rapid dose
    Rapid Dose Titration Group
    Intervention: Drug: Ziprasidone
  • Active Comparator: ziprasidone slow dose
    Slow Dose Titration Group
    Intervention: Drug: Ziprasidone
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
 (submitted: June 25, 2014)
28
Original Estimated Enrollment  ICMJE
 (submitted: February 22, 2008)
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:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
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
  • Stanley Medical Research Institute
  • Pfizer
  • Children's Medical Center Dallas
Investigators  ICMJE
Principal Investigator:Kirti Saxena, MDUT Southwestern Medical Center
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