ARIQUELI Study I: Should quetiapine monotherapy be considered for any acute presentation of bipolar disorder?

Abstract

Abstract Background: Bipolar disorder type I is a chronic disorder with a polymorphic and plastic presentation. Most clinical trials limit the evaluation of treatment to one of the poles of the acute phase. The ARIQUELI study aimed to evaluate the efficacy and tolerability of quetiapine monotherapy as a treatment for bipolar disorder overall, regardless of clinical presentation in the acute phase and in the maintenance phase. Method: The ARIQUELI study was divided into two phases: Phase I, to investigate the treatment of bipolar disorder with quetiapine monotherapy, and Phase II, to compare two augmentation strategies in the treatment of quetiapine-refractory patients. Patients aged 18 to 40 years with type I bipolar disorder received quetiapine monotherapy between 300 to 800 mg for eight weeks regardless of clinical presentation. Responders were included in a maintenance phase of up to 22 months. The primary outcome was achievement and maintenance of response scores. Outcomes for Phase I were compared between the three clinical presentation groups in the acute phase (depression/mania/mixed). Results: 105 patients were included, and although some differences in tolerability and depressive symptoms scores were observed, no difference between the groups was observed regarding primary outcome. Conclusions: Quetiapine is equally effective in treating all forms of bipolar disorder I, with smaller differences in side effects and depressed patients showing a greater reduction in depressive symptoms. Limitations: High prevalence of rapid cycling in the sample limits the comparison with other studies. Sample size was determined based on the results of the augmentation phase.