Ziprasidone in Pediatric Bipolar Disorder

This study has been completed.
Sponsor:
Collaborators:
Stanley Medical Research Institute
Pfizer
Children's Medical Center Dallas
Information provided by (Responsible Party):
Kirti Saxena, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT00622739
First received: February 13, 2008
Last updated: June 25, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Bipolar Disorder
Drug: Ziprasidone
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Ziprasidone in Pediatric Bipolar Disorder: a 6-week, Open-label Comparison of Rapid vs. Slow Dose Titration

Resource links provided by NLM:


Further study details as provided by University of Texas Southwestern Medical Center:

Primary Outcome Measures:
  • Young Mania Rating Scale (YMRS) [ Time Frame: 6 weeks of treatment ] [ Designated as safety issue: No ]
    The Young Mania Rating Scale (YMRS) is a measure of the severity of manic symptoms. The scores on the scale range from 0-56. A score of more than or equal to 14 was the cut off for inclusion into this study. A higher score denotes increased severity of manic symptoms.


Secondary Outcome Measures:
  • Clinical Global Impressions (CGI) Scale [ Time Frame: Weekly ] [ Designated as safety issue: No ]
  • SAFTEE (Side Effects Rating Scale) [ Time Frame: Weekly ] [ Designated as safety issue: Yes ]
  • AIMS (Abnormal Involuntary Movement Scale) [ Time Frame: Weekly ] [ Designated as safety issue: Yes ]
  • Children's Depression Rating Scale [ Time Frame: Weekly ] [ Designated as safety issue: No ]

Enrollment: 28
Study Start Date: February 2007
Study Completion Date: November 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: ziprasidone rapid dose
Rapid Dose Titration Group
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
Active Comparator: ziprasidone slow dose
Slow Dose Titration Group
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

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.

  Eligibility

Ages Eligible for Study:   10 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00622739

Locations
United States, Texas
UT Southwestern Medical Center
Dallas, Texas, United States, 75390
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Stanley Medical Research Institute
Pfizer
Children's Medical Center Dallas
Investigators
Principal Investigator: Kirti Saxena, MD UT Southwestern Medical Center
  More Information

No publications provided

Responsible Party: Kirti Saxena, Principal Investigator, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT00622739     History of Changes
Other Study ID Numbers: SaxenaZiprasidone
Study First Received: February 13, 2008
Results First Received: March 12, 2014
Last Updated: June 25, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Texas Southwestern Medical Center:
Bipolar Disorder
Children
Adolescents
Treatment

Additional relevant MeSH terms:
Bipolar Disorder
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders
Ziprasidone
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents

ClinicalTrials.gov processed this record on August 28, 2014