Abstract | BACKGROUND: METHODS: Outpatients meeting DSM-IV-TR criteria for bipolar I depression, were randomized to 6 weeks of once-daily, double-blind treatment with lurasidone 20-60mg, lurasidone 80-120mg or placebo, followed by a 6-month, open-label, flexible-dose, lurasidone continuation study. Recovery was defined as meeting criteria for combined symptomatic remission (Montgomery-Asberg Depression Rating Scale total score ≤12) and functional remission (all Sheehan Disability Scale domain scores ≤3) sustained for at least 3 months in the 6-month continuation study. RESULTS: A significantly higher proportion of lurasidone-treated patients met criteria for combined symptomatic remission and functional remission (33.3%, 91/273) compared to the placebo group (21.0%, 30/143, p<0.05, NNT=9) at the 6-week study endpoint. In the 6-month continuation study, the proportion of lurasidone-treated patients achieving sustained recovery was 60.7% (85/140) and 44.9% (31/69), for patients who continued lurasidone treatment and who switched from placebo to lurasidone, respectively. LIMITATIONS: The definition of recovery used has not been previously validated and the analysis was post hoc. Lack of a control group in the continuation study limits data interpretation. CONCLUSIONS: Recovery in patients with bipolar depression was assessed based on rates of combined symptomatic and functional remission sustained over time. A majority of patients initially treated with lurasidone in the acute phase achieved recovery status in the continuation study. Treatment with lurasidone (vs. placebo) earlier in the course of the bipolar depressive episode increased the likelihood of subsequent recovery.
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Authors | Antony Loebel, Cynthia Siu, Krithika Rajagopalan, Andrei Pikalov, Josephine Cucchiaro, Terence A Ketter |
Journal | Journal of affective disorders
(J Affect Disord)
Vol. 186
Pg. 376-82
(Nov 01 2015)
ISSN: 1573-2517 [Electronic] Netherlands |
PMID | 26363720
(Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Copyright | Copyright © 2015 The Authors. Published by Elsevier B.V. All rights reserved. |
Chemical References |
- Antipsychotic Agents
- Lurasidone Hydrochloride
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Topics |
- Adult
- Antipsychotic Agents
(administration & dosage)
- Bipolar Disorder
(drug therapy)
- Double-Blind Method
- Female
- Humans
- Longitudinal Studies
- Lurasidone Hydrochloride
(administration & dosage)
- Male
- Middle Aged
- Outpatients
- Psychiatric Status Rating Scales
- Remission Induction
- Time
- Treatment Outcome
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