The ARIQUELI study: potentiation of quetiapine in bipolar I nonresponders with lithium versus aripiprazole

Abstract

BackgroundThe treatment of bipolar disorder (BD) remains a challenge due to the complexity of the disease. Current guidelines represent an effort to assist clinicians in routine practice but have several limitations, particularly concerning long-term treatment. The ARIQUELI (efficacy and tolerability of the combination of lithium or aripiprazole in young bipolar non or partial responders to quetiapine monotherapy) study aims to evaluate two different augmentation strategies for quetiapine nonresponders or partial responders in acute and maintenance phases of BD treatment.Methods/DesignThe ARIQUELI study is a single-site, parallel-group, randomized, outcome assessor-blinded trial. BD I patients according to the DSM-IV-TR, in depressive, manic/hypomanic or mixed episode, aged 18 to 40 years, are eligible. After diagnostic assessments, patients initiated treatment in phase I with quetiapine. Nonresponders or partial responders after 8 weeks are allocated into one of two groups, potentiated with either lithium (0.5 to 0.8 mEq/l) or aripiprazole (10 or 15 mg). Patients will be followed up for 8 weeks in phase I (acute treatment), 6 months in phase II (continuation treatment) and 12 months in phase III (maintenance treatment). Outcome assessors are blinded to the treatment. The primary outcome is the evaluation of changes in mean scores on the CGI-BP-M between baseline and the endpoint at the end of each study phase.DiscussionThe ARIQUELI study is currently in progress, with patients undergoing acute treatment (phase I), potentiation (phase II) and maintenance (phase III). The study will be extended until January 2015. Trials comparing lithium and aripiprazole with potentiate treatment in young BD I nonresponders to quetiapine in monotherapy can provide relevant information on the safety of these drugs in clinical practice. Long-term treatment is an issue of great importance and should be evaluated further through more in-depth studies given that BD is a chronic disease.Trial registrationClinicalTrials.gov identifier: NCT01710163

Polypharmacy as maintenance treatment in bipolar illness: A systematic review

“…No efficacy literature was found for the lamotrigine + asenapine combination and for treatments with 2 antipsychotics (asenapine + aripiprazole, asenapine + quetiapine, aripiprazole + quetiapine). One RCT protocol for the aripiprazole + quetiapine combination has been published, but results were not available on the date of our search 10 …”

Maintaining mood stability in bipolar disorder: a clinical perspective on pharmacotherapy

“…It is arguably comparable to valproate for preventing mania24 but has not shown efficacy in preventing depression 13 25. Agents that show promise are being investigated; for example, the ARIQUELI study, currently nearing completion, examines whether aripiprazole (an SGA) confers benefit in preventing bipolar disorder relapse and recurrence when administered as an adjunct to quetiapine or lithium 26. It has previously been shown some prophylactic efficacy against mania but not depression27 and as adjunct to lithium or valproate 28 .…”

Aripiprazol Versus Quetiapine in Treatment of Non-affective Acute Psychosis: A Double-Blind, Randomized - Controlled Clinical Trial

“…Misso and colleagues (2013) reported Aripiprazole with potentiate treatment in nonresponders to Quetiapine can provide relevant information on the effectiveness of Aripiprazol in clinical practice [8]. Different from current study, their study conducted among patients with bipolar disorder.…”