Safety And Tolerability Of Ziprasidone In Adolescents With Schizophrenia

Phase 3 Terminated 221 enrolled Viatris Inc.

Non-randomizedSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to assess the safety and tolerability of ziprasidone during long-term open-label administration in adolescents (ages 13-17) with schizophrenia.

Timeline

Start: 2006-06
Primary completion: 2009-06
Completion: 2009-06

Outcome

Missed primary endpoint

Stopped: “Please see Detailed Description for termination reason.”

paper not significantly different (p=0.15; -14.16 [0.78] for ziprasidone and -12.35 [1.05] for placebo). PMID 24111983 ↗

Publications

Findling RL, Cavus I, Pappadopulos E, Vanderburg DG, Schwartz JH, Gundapaneni BK, DelBello MP. Ziprasidone in adolescents with schizophrenia: results from a placebo-controlled efficacy and long-term open-extension study. J Child Adolesc Psychopharmacol. 2013 Oct;23(8):531-44. doi: 10.1089/cap.2012.0068. Epub 2013 Oct 10.

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