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Sponsors and Collaborators: |
Massachusetts General Hospital Pfizer |
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Information provided by: | Massachusetts General Hospital |
ClinicalTrials.gov Identifier: | NCT00181922 |
The objective of this study is to compare the safety and effectiveness of Ziprasidone in the treatment of mania in children and adolescents with Bipolar disorder over 8 weeks. This is an exploratory, open-label study, which seeks to determine if there is evidence for efficacy. The results of this study will be used to generate hypotheses for a larger study.
Condition | Intervention | Phase |
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Bipolar Disorder Mania |
Drug: ziprasidone (Geodon) |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Open-Label Study of Ziprasidone for the Treatment of Mania in Children and Adolescents With Bipolar Spectrum Disorder |
Estimated Enrollment: | 20 |
Study Start Date: | March 2002 |
Study Completion Date: | December 2004 |
Initial clinical evidence suggests that atypical neuroleptics may play a unique therapeutic role in the management of symptoms in youth with bipolar disorder. Ziprasidone is classed as an atypical neuroleptic because of its unique pharmacological profile that includes both D2 and 5HT2 antagonistic effects. This combined dopaminergic and serotonergic activity seems to be associated not only with antipsychotic effects but also with mood stabilizing, mood elevating and anti-aggressive effects as well as a lower risk for extrapyramidal symptoms and tardive dyskinesia.
Ziprasidone in particular has been found to have a higher 5HT2A to D2 receptor affinity ratio, which suggests that the likelihood of extrapyramidal symptoms and hyperprolactinemia may be further decreased. This makes it an ideal candidate to treat mania in children, but although it is used in clinical practice, adequate data has not been collected on its safety and effectiveness. This study included 1) an 8-week acute period, during which participants were observed during weekly visits, and up to a 10-month extension period, during which participants saw a study clinician on a monthly basis, to document the response rate 2) assessment of the impact of Ziprasidone on functional capacities (quality of life, psychosocial function) and cognition, 3) careful assessment of safety and tolerability.
Ages Eligible for Study: | 6 Years to 17 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Massachusetts | |
Massachusetts General Hospital | |
Cambridge, Massachusetts, United States, 02138 | |
Massachusetts General Hospital | |
Cambridge, Massachusetts, United States, 02138 |
Principal Investigator: | Joseph Biederman, MD | Massachusetts General Hospital |
Responsible Party: | Massachusetts General Hospital ( Joseph Biederman, MD ) |
Study ID Numbers: | 2002-p-000183 |
Study First Received: | September 13, 2005 |
Last Updated: | July 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00181922 |
Health Authority: | United States: Food and Drug Administration |
bipolar disorder children ziprasidone mania |
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 |