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Sponsors and Collaborators: |
University of Texas Southwestern Medical Center Stanley Medical Research Institute Pfizer Children's Medical Center Dallas |
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Information provided by: | University of Texas Southwestern Medical Center |
ClinicalTrials.gov Identifier: | NCT00622739 |
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 |
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Bipolar Disorder |
Drug: Ziprasidone |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Ziprasidone in Pediatric Bipolar Disorder: a 6-Week, Open-Label Comparison of Rapid vs. Slow Dose Titration |
Estimated Enrollment: | 60 |
Study Start Date: | February 2007 |
Estimated Study Completion Date: | August 2009 |
Estimated Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Rapid Dose Titration Group
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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.
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2: Active Comparator
Slow Dose Titration Group
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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.
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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.
Ages Eligible for Study: | 10 Years to 17 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Annie Walley, MSW | 214-456-2416 | annie.walley@utsouthwestern.edu |
Contact: Jaime Murphy, BA | 214-456-8918 | jaime.murphy@utsouthwestern.edu |
United States, Texas | |
UT Southwestern Medical Center | Recruiting |
Dallas, Texas, United States, 75390 | |
Principal Investigator: Kirti Saxena, MD |
Principal Investigator: | Kirti Saxena, MD | UT Southwestern Medical Center |
Responsible Party: | UT Southwestern Medical Center ( Kirti Saxena, MD ) |
Study ID Numbers: | SaxenaZiprasidone |
Study First Received: | February 13, 2008 |
Last Updated: | October 27, 2008 |
ClinicalTrials.gov Identifier: | NCT00622739 |
Health Authority: | United States: Institutional Review Board |
Bipolar Disorder Children Adolescents Treatment |
Affective Disorders, Psychotic Dopamine Mental Disorders Bipolar Disorder |
Mood Disorders Psychotic Disorders Ziprasidone Serotonin |
Neurotransmitter Agents Disease Tranquilizing Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Psychotropic Drugs Central Nervous System Depressants Dopamine Antagonists |
Antipsychotic Agents Pharmacologic Actions Serotonin Antagonists Pathologic Processes Serotonin Agents Therapeutic Uses Dopamine Agents Central Nervous System Agents |