Achievable Maintenance for adult patients with
bipolar I disorder
Significantly delayed time to recurrence of any mood episode vs placebo (P<0.0001)1
52-Week Maintenance Study
Primary endpoint: Time from randomization to recurrence* of any mood episode *Recurrence was defined as clinical worsening, psychiatric hospitalization, or increased risk of suicide.
In a 52-week study, the risk of recurrence of any mood episode was reduced by about half with
- Significantly delayed time to recurrence for a manic episode and mixed episode. No substantial difference in the time to a depressive episode
†This figure is based on a total of 103 recurrences.
Adapted from Calabrese et al.
- Open-label phase (Phase 2), patients were stabilized on oral aripiprazole 15 mg to 30 mg/day
- Single-blind phase (Phase 3), patients were converted to and stabilized on
ABILIFY MAINTENA400 mg (patients also continued on oral aripiprazole 10 mg to 20 mg for the first 14 days following the initial ABILIFY MAINTENAdose)
- Double-blind, placebo-controlled phase (Phase 4), patients were randomized to either intramuscular (IM)
ABILIFY MAINTENA(n=133) or IM placebo (n=133)
During the double-blind, placebo-controlled phase, use of benzodiazepines or lorazepam equivalent was allowed up to a maximum of 2 mg/day and 4 mg/week.
‡For patients naïve to aripiprazole, establish tolerability with oral aripiprazole prior to initiating
Key secondary endpoint: Proportion of patients meeting criteria for recurrence of any mood episode. Only 27% of patients had a recurrence of any mood episode vs 51% on placebo (P<0.0001)1
73% of patients were recurrence-free§ vs 49% on placebo at study end1,2
§Proportion of patients who did not meet criteria for recurrence
91% of patients randomized to
remained on the 400-mg dose at the end of the
Physicians had the option to reduce the dose from 400 mg to 300 mg for tolerability during Phase 4.
Important Warning and Precaution Regarding Tardive Dyskinesia (TD):