Bipolar Disorder Clinical Trial
Official title:
Open-Label Study of Ziprasidone for the Treatment of Mania in Children and Adolescents With Bipolar Spectrum Disorder
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.
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.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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