Characteristics of Patients in Recovery Versus Patients With Recurrence in a Randomized Placebo-Controlled Study With Aripiprazole Once-Monthly as Maintenance Treatment for Bipolar I Disorder

Aims. To describe the background and clinical characteristics of patients who did versus those who did not have a recurrence of a mood episode during up to 52 weeks of maintenance treatment with aripiprazole once-monthly 400 mg (AOM 400) for bipolar I disorder (BP-I).

Methods. The study (NCT01567527) included outpatients aged 18–65 years with a DSM-IV-TR diagnosis of BP-I and a current manic episode at enrollment. Patients were stabilized on oral aripiprazole, then on AOM 400; those meeting stabilization criteria were subsequently randomized 1:1 to a 52-week double-blind, placebo-controlled withdrawal phase. Recovery was defined as mania and depression scale scores of ≤12 for 8 consecutive weeks. Recurrence of a mood episode was defined by criteria that included hospitalization; mania, depression, and global clinical impression scale scores; disease or clinical worsening; discontinuation for lack of efficacy; or active suicidality. Baseline characteristics of the patients treated with AOM 400, including age, gender, and key disease characteristics, are summarized by recovery/recurrence status.

Results. A total of 133 patients were treated with AOM 400. Of these, 26.3% (n=35) had recurrence whereas 68.4% (n=91) were in recovery/remission. Most baseline characteristics in the two outcome groups were similar, including age, gender, age at diagnosis of BP-I, and disease severity scores. Patients with recurrence had more mean life-time depressive episodes (11.7) at baseline than patients in recovery/remission (6.5).

Conclusions.  Life-time depressive episodes were associated with recurrence; other baseline characteristics were similar between patients with recurrence and those in recovery/remission.