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Efficacy, safety, and tolerability of augmentation pharmacotherapy with aripiprazole for treatment-resistant depression in late life: a randomised, double-blind, placebo-controlled trial
Open accessAbstract
Background 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. We aimed to assess whether aripiprazole is associated with a higher probability of remission than is placebo.Methods We did a randomised, double-blind, placebo-controlled trial 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 computer-generated randomisation was done in blocks and stratified by site. Only the database administrator and research pharmacists had knowledge of treatment assignment. 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, analysed by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT00892047.Findings From July 20, 2009, to Dec 30, 2013, we recruited 468 eligible participants, 181 (39%) of whom did not remit and were randomly assigned to aripiprazole (n=91) or placebo (n=90). A greater proportion of participants in the aripiprazole group achieved remission than did those in the placebo group (40 [44%] vs 26 [29%] participants; odds ratio [OR] 2·0 [95% CI 1·1-3·7], p=0·03; number needed to treat [NNT] 6·6 [95% CI 3·5-81·8]). Akathisia was the most common adverse effect of aripiprazole (reported in 24 [26%] of 91 participants on aripiprazole vs 11 [12%] of 90 on placebo). Compared with placebo, aripiprazole was also associated with more Parkinsonism (15 [17%] of 86 vs two [2%] of 81 participants), but not with treatment-emergent suicidal ideation (13 [21%] of 61 vs 19 [29%] of 65 participants) or other measured safety variables.Interpretation 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 include the potential for akathisia and Parkinsonism.Funding National Institute of Mental Health, UPMC Endowment in Geriatric Psychiatry, Taylor Family Institute for Innovative Psychiatric Research, National Center for Advancing Translational Sciences, and the Campbell Family Mental Health Research Institute.
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“This remission rate is comparable with those seen in our previous bilateral rTMS trial (33%)7 and deep rTMS trial (40%)32 and comparable with the remission rate seen with aripiprazole augmentation in older adults with TRD.33”
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“The largest published randomized controlled trial to date amongst older adults (“IRL GREY”) – a multi‐site, double‐blind, placebo‐controlled trial of aripiprazole augmentation of primary pharmacotherapy with venlafaxine – demonstrated efficacy for augmentation, yielding a 44% remission rate versus 29% with placebo (number needed to treat: 6.6) 222 .”
From Mental health care for older adults: recent advances and new directions in clinical practice and research (2022) · cites this paper as [222]
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“Aripiprazole was well tolerated in analyses of both cardiometabolic and neurological outcomes, and led to a reduction in the prevalence and severity of suicidal ideation.”
From Mental health care for older adults: recent advances and new directions in clinical practice and research (2022) · cites this paper as [222]
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“Augmentation of antidepressants with either lithium131 or with the aripiprazole132 have been found effective in late-life major depression unresponsive to an antidepressant.”
From Mechanisms and treatment of late-life depression (2019) · cites this paper as [132]
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Metadata
- Authors
- Lenze, E. J., Mulsant, B. H., Blumberger, D. M., Karp, J. F., Newcomer, J. W., Anderson, S. J., Dew, M. A., Butters, M. A., Stack, J. A., Begley, A. E., & Reynolds, C. F.
- Affiliations
- Washington University in St. Louis (US)
- Centre for Addiction and Mental Health (CA)
- University of Pittsburgh (US)
- Florida Atlantic University (US)
- Corresponding author
- Lenze, Eric J
- ORCID
- Venue
- The Lancet
- Publisher
- Elsevier BV
- Published
- 2015-12
- Volume
- 386
- Issue
- 10011
- Pages
- 2404-2412
- ISSN
- 0099-5355 (ISSN-L)
- 0140-6736
- PMC
- PMC4690746
- OpenAlex
- W1780931260
- Cited by
- 283
- References
- 60
- Citations by year
- 2026: 15 · 2025: 17 · 2024: 25 · 2023: 28 · 2022: 26 · 2021: 25 · 2020: 50 · 2019: 26 · 2018: 21 · 2017: 21 · 2016: 23 · 2015: 6
- FWCI
- 16.92
- Type
- journal article
- Language
- en
- Update notices
- Open access
- bronze
- doi.org
- Licence
- Locations
- The Lancet (publishedVersion)
- PubMed (publishedVersion)
- Europe PMC (PubMed Central) (acceptedVersion)
- PubMed Central (acceptedVersion)
- Funders
- National Institute of Mental Health (P30 MH90333, R01 MH083660)
- National Heart, Lung, and Blood Institute
- Roche
- Centre for Addiction and Mental Health
- Brain and Behavior Research Foundation
- National Center for Complementary and Integrative Health
- American Foundation for Suicide Prevention
- Centre for Addiction and Mental Health Foundation
- National Center on Minority Health and Health Disparities
- National Institutes of Health
- H. Lundbeck A/S
- National Palliative Care Research Center
- Fondation Brain Canada
- John A. Hartford Foundation
- Commonwealth of Pennsylvania
- National Institute on Aging
- Canadian Institutes of Health Research
- Topics
- Health Sciences › Medicine › Pharmacology (medical) › Treatment of Major Depression
- Health Sciences › Medicine › Psychiatry and Mental health › Schizophrenia research and treatment
- Health Sciences › Medicine › Psychiatry and Mental health › Electroconvulsive Therapy Studies
- Keywords
- treatment-resistant depression, geriatric depression, elderly patients, antidepressant augmentation, venlafaxine, akathisia, antipsychotic adverse effects, remission, tolerability, number needed to treat, number needed to harm, adverse drug reactions, anticholinergic effects
- MeSH terms
- Aripiprazole, Aged, Antidepressive Agents, Double-Blind Method, Drug Administration Schedule, Female, Humans, Male, Middle Aged, Parkinson Disease, Secondary, Recurrence, Treatment Outcome, Akathisia, Drug-Induced, Depressive Disorder, Treatment-Resistant
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