According to the authors of this study, treatment-resistant major depression is common and potentially life-threatening in elderly people, in whom little is known about the benefits and risks of augmentation pharmacotherapy. The purpose of this study was to assess whether aripiprazole is associated with a higher probability of remission than placebo.
A randomised, double-blind, placebo-controlled trial was conducted at three centres in the USA and Canada to test the efficacy and safety of aripiprazole augmentation for adults aged older than 60 years with treatment-resistant depression (Montgomery Asberg Depression Rating Scale [MADRS] score of ≥15). Patients who did not achieve remission during a pre-trial with venlafaxine extended-release (150–300 mg/day) were randomly assigned (1:1) to the addition of aripiprazole (target dose 10 mg [maximum 15 mg] daily) daily or placebo for 12 weeks. The primary endpoint was remission, defined as an MADRS score of 10 or less (and at least 2 points below the score at the start of the randomised phase) at both of the final two consecutive visits.
A greater proportion of participants in the aripiprazole group achieved remission than did those in the placebo group. Akathisia was the most common adverse effect of aripiprazole (for 26% of participants on aripiprazole vs 1% of those on placebo). Compared with placebo, aripiprazole was also associated with more Parkinsonism (17% vs 2% of participants), but not with treatment-emergent suicidal ideation or other measured safety variables. The authors concluded that in adults aged 60 years or older who do not achieve remission from depression with a first-line antidepressant, the addition of aripiprazole is effective in achieving and sustaining remission. Tolerability concerns included the potential for akathisia and Parkinsonism.
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Lenze EJ, Mulsant BH, Blumberger DM, Karp JF, Newcomer JW, Anderson SJ, Dew MA, Butters MA, Stack JA, Begley AE, Reynolds CF III: Efficacy, safety, and tolerability of augmentation pharmacotherapy with aripiprazole for treatment-resistant depression in late life: a randomised, double-blind, placebo-controlled trial. The Lancet [Epub ahead of print Sept.27, 2015; doi: http://dx.doi.org/10.1016/S0140-6736(15)00308-6].
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http://www.thelancet.com/journals/lancet/article/PIIS0140-6736%2815%2900308-6/abstract