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One such inequity is the provision of earlier treatment. Earlier treatment of patients diagnosed with bipolar disorder may prolong time to recurrence of mood episodes and reduce functional impairment and other poor outcomes associated with disease progression. The aim of this <jats:italic>post hoc<\/jats:italic> analysis was to study the efficacy and safety of long-acting injectable aripiprazole once-monthly 400 mg (AOM 400) in patients with earlier-stage bipolar I disorder (BP-I). Data from a 52-week multicenter, double-blind, placebo-controlled, randomized withdrawal trial of AOM 400 versus placebo in patients with BP\u2011I (NCT01567527) were analyzed. Those patients in the lowest quartiles for age (18\u2013\u226432 years; n\u00a0=\u00a070) or disease duration (0.13\u2013\u22644.6 years; n\u00a0=\u00a067) at baseline were categorized with earlier-stage BP-I. The primary endpoint was time from randomization to recurrence of any mood episode. Other endpoints included proportion of patients with recurrence of any mood episode, and change from baseline in Young Mania Rating Scale (YMRS) and Montgomery\u2013\u00c5sberg Depression Rating Scale (MADRS) total scores.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Results<\/jats:title>\n                <jats:p>Maintenance treatment with AOM 400 significantly delayed time to recurrence of any mood episode versus placebo in patients aged 18\u2013\u226432\u00a0years (hazard ratio [HR]: 2.46 [95% confidence interval (CI) 1.09, 5.55]; p\u00a0=\u00a00.0251) or with disease duration 0.13\u2013\u22644.6 years (HR: 3.21 [95% CI 1.35, 7.65]; p\u00a0=\u00a00.005). This was largely driven by a lower proportion of patients in the AOM 400 group with YMRS total score \u226515 or clinical worsening. Changes from baseline in MADRS total score in both earlier-stage groups indicated AOM 400 did not worsen depression versus placebo. The safety profile of AOM 400 was consistent with the original study. Note that the original study included patients who had previously been stabilized on AOM 400 monotherapy, which may have enriched the population with patients who respond to and tolerate AOM 400.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Conclusions<\/jats:title>\n                <jats:p>In this <jats:italic>post hoc<\/jats:italic> analysis, AOM 400 prolonged time to recurrence of any mood episode versus placebo in earlier-stage BP-I. These findings support early initiation of maintenance treatment with AOM 400.<\/jats:p>\n              <\/jats:sec>","DOI":"10.1186\/s40345-024-00358-3","type":"journal-article","created":{"date-parts":[[2024,10,28]],"date-time":"2024-10-28T08:42:42Z","timestamp":1730104962000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":3,"title":["Aripiprazole once-monthly for the treatment of adult patients with earlier-stage bipolar I disorder: a post hoc analysis of data from a double-blind, placebo-controlled, 52-week randomized withdrawal trial"],"prefix":"10.1186","volume":"12","author":[{"given":"Karimah S.","family":"Bell Lynum","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christine F.","family":"Castro","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zhen","family":"Zhang","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mehul","family":"Patel","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mauricio","family":"Tohen","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2024,10,27]]},"reference":[{"key":"358_CR1","unstructured":"Abilify Asimtufii\u00ae (aripiprazole). 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The list of IRBs is included as a supplement.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"Not applicable.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"Karimah S. Bell Lynum is a full-time employee of Otsuka Pharmaceutical Development & Commercialization, Inc., Princeton, NJ, USA. Christine F. Castro is a full-time employee of Lundbeck LLC, Deerfield, IL, USA. Zhen Zhang is a full-time employee of Otsuka Pharmaceutical Development & Commercialization, Inc., Princeton, NJ, USA. Mehul Patel is a full-time employee of Otsuka Pharmaceutical Development & Commercialization, Inc., Princeton, NJ, USA. Mauricio Tohen has received honoraria or consultation fees from Abbott, AbbVie, Alkermes, AstraZeneca, Elan, Gedeon Richter, Intracellular Therapies, Johnson & Johnson, Lilly, Lundbeck, Merck, Minerva, Neurocrine Biosciences, Otsuka, Pfizer, Roche, Sunovion, and Teva. Professor Tohen was an employee at Lilly (1997\u20132008); his spouse was an employee at Lilly (1998\u20132013).","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"37"}}