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

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

Outcome

Missed primary endpoint

paper Mean treatment differences between adjunctive ziprasidone groups and placebo were not statistically significant on primary or secondary efficacy measures. PMID 23218157 ↗

registry analysis (unspecified test); Ziprasidone (Lower Dose) vs Placebo; p = 0.1077; Mixed Models Analysis NCT00312494 ↗

registry analysis (unspecified test); Ziprasidone (Higher Dose) vs Placebo; p = 0.4274; Mixed Models Analysis NCT00312494 ↗

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