Efficacy and Safety Trial of Flexible Doses of Oral Ziprasidone in Children and Adolescents With Bipolar I Disorder

NCT02075047 ↗

Phase 3 Terminated 171 enrolled Viatris Inc.

RandomizedParallel-groupTriple-blindTreatment

Summary

The purpose of this study is to determine if ziprasidone is safe and effective for the treatment of children and adolescents (ages 10-17) with bipolar I disorder (manic or mixed).

Timeline

Start: 2014-05-23
Primary completion: 2020-04-11
Completion: 2020-05-18

Publications

Findling RL, Atkinson S, Bachinsky M, Raiter Y, Abreu P, Ianos C, Chappell P. Efficacy, Safety, and Tolerability of Flexibly Dosed Ziprasidone in Children and Adolescents with Mania in Bipolar I Disorder: A Randomized Placebo-Controlled Replication Study. J Child Adolesc Psychopharmacol. 2022 Apr;32(3):143-152. doi: 10.1089/cap.2021.0121. Epub 2022 Apr 7.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ziprasidone	Small molecule	20 mg	Oral
Subject	Ziprasidone	Small molecule	40 mg	Oral
Subject	Ziprasidone	Small molecule	60 mg	Oral
Subject	Ziprasidone	Small molecule	80 mg	Oral

Efficacy and Safety Trial of Flexible Doses of Oral Ziprasidone in Children and Adolescents With Bipolar I Disorder

Summary

Timeline

Publications

Drugs

Indications