Adjunctive Ziprasidone in the Treatment of Bipolar I Depression

Summary

The purpose of this study is to determine if a treatment regimen of ziprasidone plus a mood stabilizer is safe and effective in the short term treatment of Bipolar I Depression. Ziprasidone will be added to lithium, valproate or lamotrigine after the patient has been on a therapeutic dose of one of these mood stabilizers for at least 4 weeks.

Timeline

Start

2007-10

Primary completion

2008-12

Completion

2008-12

Outcome

Missed primary endpoint

registry analysis (unspecified test); Ziprasidone vs Placebo; p = 0.7921; Least squares mean -0.36 (95% CI -3.07 to 2.34); NCT00483548 ↗

paper CONCLUSIONS: Adjunctive ziprasidone treatment failed to separate from mood stabilizer alone on primary and secondary endpoints. PMID 21672493 ↗

Publications

• Sachs GS, Ice KS, Chappell PB, Schwartz JH, Gurtovaya O, Vanderburg DG, Kasuba B. Efficacy and safety of adjunctive oral ziprasidone for acute treatment of depression in patients with bipolar I disorder: a randomized, double-blind, placebo-controlled trial. J Clin Psychiatry. 2011 Oct;72(10):1413-22. doi: 10.4088/JCP.09m05934.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ziprasidone	Small molecule	40 mg	Oral
Subject	Ziprasidone	Small molecule	60 mg	Oral
Subject	Ziprasidone	Small molecule	80 mg	Oral
Subject	Ziprasidone	Small molecule	100 mg	Oral
Subject	Ziprasidone	Small molecule	120 mg	Oral
Subject	Ziprasidone	Small molecule	140 mg	Oral
Subject	Ziprasidone	Small molecule	160 mg	Oral

Indications