drugset

drugset / Trial / NCT00312494

3-week Study to Evaluate Efficacy and Safety of Ziprasidone With Either Lithium or Divalproex in Acutely Manic Subjects

NCT00312494 ↗

Phase 3 Completed 680 enrolled Viatris Inc.

RandomizedParallel-groupQuadruple-blindTreatment

Summary

3-week study to evaluate efficacy and safety of ziprasidone with either lithium or divalproex in acutely manic subjects

Timeline

Start: 2006-04
Primary completion: 2008-12
Completion: 2008-12

Publications

Sachs GS, Vanderburg DG, Edman S, Karayal ON, Kolluri S, Bachinsky M, Cavus I. Adjunctive oral ziprasidone in patients with acute mania treated with lithium or divalproex, part 2: influence of protocol-specific eligibility criteria on signal detection. J Clin Psychiatry. 2012 Nov;73(11):1420-5. doi: 10.4088/JCP.11m07389.
Sachs GS, Vanderburg DG, Karayal ON, Kolluri S, Bachinsky M, Cavus I. Adjunctive oral ziprasidone in patients with acute mania treated with lithium or divalproex, part 1: results of a randomized, double-blind, placebo-controlled trial. J Clin Psychiatry. 2012 Nov;73(11):1412-9. doi: 10.4088/JCP.11m07388.

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

Indications