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Cited by 141Treatment of Major DepressionSchizophrenia research and treatmentBipolar Disorder and Treatment

A Double-Blind, Placebo-Controlled Study of Aripiprazole Adjunctive to Antidepressant Therapy among Depressed Outpatients with Inadequate Response to Prior Antidepressant Therapy (ADAPT-A Study)

Fava, Maurizio, Mischoulon, David, Iosifescu, Dan, Witte, Janet, Pencina, Michael, Flynn, Martina, Harper, Linda, Levy, Michael +2 more·2012·Psychotherapy and Psychosomatics
DOI 10.1159/000332050
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Abstract

BACKGROUND: We assessed the efficacy of low-dose aripiprazole added to antidepressant therapy (ADT) in major depressive disorder (MDD) patients with inadequate response to prior ADT. METHODS: As per the sequential parallel comparison design, 225 MDD subjects were randomized to adjunctive treatment with aripiprazole 2 mg/day or placebo across two 30-day phases, with a 2:3:3 randomization ratio to drug/drug (aripiprazole 2 mg/day in phase 1; 5 mg/day in phase 2), placebo/placebo (placebo in both phases), and placebo/drug (placebo in phase 1; aripiprazole 2 mg/day in phase 2). Eligible subjects were patients whose MDD was independently deemed 'valid' with SAFER criteria. Subjects had been receiving ADT for ≥8 weeks, and had inadequate response to ≥1 and <4 adequate ADTs in the current episode, as defined by the Antidepressant Treatment Response Questionnaire. RESULTS: The pooled, weighted response difference between aripiprazole 2 mg/day and placebo in the two phases was 5.6% (p = 0.18; NS). The aripiprazole 2 mg/day-placebo difference on the Montgomery-Asberg Depression Rating Scale pooled across the two phases was -1.51 (p = 0.065; NS). Other secondary endpoint analyses showed nonsignificant pooled differences favoring aripiprazole over placebo. Of the 225 randomized subjects in phase 1, 2 dropped out in both arms, while in phase 2, of 138 phase 1 placebo nonresponders, 9 dropped out on aripiprazole and 5 on placebo. There were only minimal differences in adverse event rates between treatments, except for constipation, weight gain, and dry mouth, more common on aripiprazole. CONCLUSIONS: This study provides clear support for the tolerability of low-dose aripiprazole as an ADT-augmenting agent, with marginal efficacy.

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Authors
Fava, M., Mischoulon, D., Iosifescu, D., Witte, J., Pencina, M., Flynn, M., Harper, L., Levy, M., Rickels, K., & Pollack, M.
Affiliations
  • Massachusetts General Hospital (US)
  • Icahn School of Medicine at Mount Sinai (US)
  • Boston University (US)
  • CNS Healthcare (US)
  • Behavioral Medical Research (US)
  • University of Pennsylvania (US)
  • Rush University Medical Center (US)
ORCID
Venue
Psychotherapy and Psychosomatics
Publisher
S. Karger AG
Published
2012
Volume
81
Issue
2
Pages
87-97
ISSN
  • 0033-3190 (ISSN-L)
  • 1423-0348
DOI
10.1159/000332050
OpenAlex
W2021939430
Cited by
141
References
25
Citations by year
2026: 1 · 2025: 5 · 2024: 7 · 2023: 9 · 2022: 6 · 2021: 9 · 2020: 9 · 2019: 14 · 2018: 11 · 2017: 9 · 2016: 9 · 2015: 14 · 2014: 13 · 2013: 18 · 2012: 6
FWCI
12.00
Type
journal article
Language
en
Open access
closed
Licence
Locations
  • Psychotherapy and Psychosomatics (publishedVersion)
  • PubMed (publishedVersion)
Funders
Bristol-Myers Squibb
Topics
  • Health Sciences › Medicine › Pharmacology › Treatment of Major Depression
  • Health Sciences › Medicine › Psychiatry and Mental health › Schizophrenia research and treatment
  • Health Sciences › Medicine › Psychiatry and Mental health › Bipolar Disorder and Treatment
Keywords
aripiprazole, major depressive disorder, antidepressant augmentation, adjunctive therapy, treatment response, adverse events, constipation, weight gain, xerostomia
MeSH terms
Aripiprazole, Adolescent, Adult, Aged, Antidepressive Agents, Constipation, Major Depressive Disorder, Depressive Disorder, Major, Double-Blind Method, Drug Therapy, Combination, Female, Humans, Male, Middle Aged, Piperazines, Placebos, Severity of Illness Index, Antipsychotic Agents, United States, Models, Statistical, Quinolones, Weight Gain, Treatment Outcome, Selective Serotonin Reuptake Inhibitors, Young Adult, Depressive Disorder, Treatment-Resistant

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