Lurasidone and Cognition in Bipolar I Disorder

Summary

This is a 6 week, randomized, open-label, parallel group study in patients with Bipolar-I disorder (manic depression), who are in remission from an episode. Participants who show cognitive impairment at baseline will be randomized to receive open-label Lurasidone added on to their current medication(s) or continue their usual treatment for 6 weeks. Participants will have 3 clinical visits and 2 telephone appointments during the study. Given the preliminary evidence for efficacy of Lurasidone in improving cognition in schizophrenia, we propose to examine the efficacy of Lurasidone in improving cognition in bipolar patients.

Timeline

Start

2014-05

Primary completion

2015-10

Completion

2017-01-12

Outcome

Met primary endpoint

paper Lurasidone adjunctive therapy was more effective than TAU in improving the primary efficacy measure of ISBD-BANC global cognition score PMID 28185899 ↗

paper time × treatment interaction F=5·09; p=0·032 PMID 28185899 ↗

Publications

• Yatham LN, Mackala S, Basivireddy J, Ahn S, Walji N, Hu C, Lam RW, Torres IJ. Lurasidone versus treatment as usual for cognitive impairment in euthymic patients with bipolar I disorder: a randomised, open-label, pilot study. Lancet Psychiatry. 2017 Mar;4(3):208-217. doi: 10.1016/S2215-0366(17)30046-9. Epub 2017 Feb 7.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Lurasidone	Small molecule	20 mg	—
Subject	Lurasidone	Small molecule	80 mg	—

Indications