Aripiprazole as an adjunctive treatment for refractory unipolar depression

Hellerstein, David J.; Batchelder, Sarai; Hyler, Steven E.; Arnaout, Bachaar; Corpuz, Virginia; Coram, Lisa; Weiss, Gony

doi:10.1016/j.pnpbp.2007.11.024

Cited by 23 publications

(12 citation statements)

References 23 publications

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“…[58][59][60][61][62][63][64][65][66][67] The majority of these open-label trials showed that response and remission rates (defined a priori) with aripiprazole augmentation of antidepressants or cognitive behavioural therapy reach at least 50%, respectively, and that at least a 30% improvement in depressive symptoms was observed compared with that measured at baseline.…”

Section: Open-label Trialsmentioning

confidence: 99%

Aripiprazole as Adjunctive Therapy for Patients with Major Depressive Disorder

2011

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Aripiprazole was initially approved to treat schizophrenia and later approved for bipolar mania, as a monotherapy and an adjunctive therapy (manic or mixed episodes), and for irritability associated with autism. Aripiprazole is a partial agonist at dopamine D(2) and D(3) and serotonin 5-HT(1A) receptors, and is an antagonist at 5-HT(2A) receptors. This profile, and convincing preliminary data from small-scale studies, provided the rationale for the large-scale exploration of aripiprazole for unipolar depression. Recently, three 6-week, large-scale, randomized, double-blind, placebo-controlled clinical trials demonstrated clinically meaningful efficacy for aripiprazole as an adjunctive therapy to antidepressants for treating major depressive disorder (MDD). In November 2007, aripiprazole was approved by the US FDA as an adjunctive therapy to antidepressants for treating MDD, with support from two of the above-mentioned trials. In the trials, aripiprazole was demonstrated to be safe and well tolerated, and showed a minimal trend for weight gain over the course of a 6-week treatment. The incidence of akathisia was higher than that reported in studies of patients with schizophrenia; however, most cases were mild to moderate and infrequently lead to discontinuation (5/1090 from all three trials). This comprehensive review provides an overview of the data from all three 6-week studies (including a pooled analysis) and from an unpublished 52-week, open-label extension study, to inform physicians and facilitate reasonable treatment decisions. In addition, specific issues associated with the use of aripiprazole as an adjunctive therapy in patients with MDD, including possible early treatment effect, appropriate timing of therapy initiation, appropriate dosing and duration of treatment, possible differential effect on depressive subgroups and long-term tolerability, are also discussed.

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Section: Open-label Trialsmentioning

confidence: 99%

Aripiprazole as Adjunctive Therapy for Patients with Major Depressive Disorder

2011

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“…Among the subject male was 317 (197 from RCTs and 137 from OLSs, 33.7%). The mean subject number of OLSs18,19,20,21,22,23,24,25,26,27,28,29,30 and RCTs31,32,33,34,35 were 27 and 125.4, respectively. The mean ages of OLSs and RCTs were 48.0 (11.5) and 43.6 (11.0) years, respectively.…”

Section: Resultsmentioning

confidence: 97%

“…Briefly, the clinical benefit of AA for treating patients with MDD have been proven in a number of early phase small scale OLSs with a use of various primary efficacy rating scales such as HAMD, MADRS and QIDS-16 18,19,20,21,22,23,24. In the small OLSs, the primary endpoint improvement was variable across the studies due to multiple factors (e.g., patient characteristics, AA dose, duration of treatment, e.t.c.…”

Section: Resultsmentioning

confidence: 99%

A Meta-Analysis Comparing Open-Label versus Placebo-Controlled Clinical Trials for Aripiprazole Augmentation in the Treatment of Major Depressive Disorder: Lessons and Promises

Pae

Seo

Lee

et al. 2014

Psychiatry Investig

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ObjectiveThe present study is to provide whether open-label studies (OLS) may properly foresee the efficacy of randomized, placebo-controlled trials (RCTs) using OLSs and RCTs data for aripiprazole in the treatment of MDD, with the use of meta-analysis approach.MethodsA search of the studies used the key terms "depression and aripiprazole" from the databases of PubMed/PsychInfo from Jan 2005 through July 2013. The data were selected and verified for publication in English-based peer-reviewed journals based on rigorous inclusion criteria. Extracted data were delivered into and run by the Comprehensive Meta Analysis program v2.ResultsThe pooled SMDs for the primary efficacy measure was statistically significant, pointing out the significant reduction of depressive symptoms after aripiprazole augmentation (AA) to current antidepressant treatment in OLSs (pooled SMD=-2.114, z=-9.625, p<0.001); similar results were also found in RCTs (pooled SMD=-2.202, z=-6.862, p<0.001). The meta-regression analysis revealed no influence of the study design for treatment outcome.ConclusionThere was no difference in the treatment effects of aripiprazole as an augmentation therapy in both OLSs and RCTs, indicating that open-label design may be a potentially useful predictor for treatment outcomes of controlled-clinical trials. The proper conduction of OLSs may provide informative, useful and preliminary clinical data and factors to be involved in controlled-clinical trials, by which we may have better understanding on the role of AA (e.g., dosing issues, proper duration of treatment, specific population for AA) implicated in the treatment of MDD in clinical practice.

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“…However, currently available data indicate that the minimally effective AA dose is likely to enhance the likelihood of good treatment outcomes in Asian patients. Most recent studies have suggested that the optimal starting and target daily doses of aripiprazole may be between 2-5 and 10-15 mg/day, which appear tolerable for most depressed patients [9,[19][20][21][22], in contrast to earlier findings [23][24][25][26][27]. The authors of the aripiprazole registration trials thought that the adjunct aripiprazole for patients with MDD would require a lower dose than they initially considered [26,27].…”

Section: Clinical Points For the Use Of Atypical Antipsychotics For Mmentioning

confidence: 99%

Do We Need to Consider Ethno-cultural Variation in the Use of Atypical Antipsychotics for Asian Patients with Major Depressive Disorder?

Han

Pae

2013

CNS Drugs

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Asian and western countries differ in the prevalence, symptom manifestation, diagnostic procedures, patient recognition and treatments of major depressive disorder (MDD), according to a number of studies. Ethnic differences in pharmacological profiles are also important in the prescription of certain antipsychotic medications because they may impact treatment outcomes and adverse events. Differential pharmacokinetic and pharmacodynamic properties of antipsychotics may be practically useful in the control of specific depressive symptoms. Furthermore, patient compliance with prescribed medications has been found to be different across races and ethnicities. Therefore, this article explores practical clinical issues for the use of atypical antipsychotics in patients with MDD, focusing on ethno-cultural differences.

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Aripiprazole as an adjunctive treatment for refractory unipolar depression

Abstract: These findings support previous studies for the effectiveness of aripiprazole in augmenting SSRIs or SNRIs in treatment-resistant major depression.

Cited by 23 publications

References 23 publications

Aripiprazole as Adjunctive Therapy for Patients with Major Depressive Disorder

Aripiprazole as Adjunctive Therapy for Patients with Major Depressive Disorder

A Meta-Analysis Comparing Open-Label versus Placebo-Controlled Clinical Trials for Aripiprazole Augmentation in the Treatment of Major Depressive Disorder: Lessons and Promises

Do We Need to Consider Ethno-cultural Variation in the Use of Atypical Antipsychotics for Asian Patients with Major Depressive Disorder?

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