Effect of Adding Aripiprazole as Adjunctive Therapy for Obsessive-Compulsive Symptoms in Patients with Bipolar I Disorder

Abstract

Background: Obsessive-compulsive disorder (OCD) remains a substantial challenge for healthcare systems despite the availability of established therapeutic agents. In clinical practice, managing comorbid OCD symptoms in the context of other psychiatric conditions often requires specialized pharmacological interventions to optimize outcomes. Objectives: This randomized, double-blind, placebo-controlled trial evaluated the efficacy of adjunctive aripiprazole in reducing obsessive-compulsive symptom severity in patients with Bipolar I Disorder (BP-I) at Golestan Hospital in Ahvaz. Methods: This study included two groups of 23 patients diagnosed with BP-I. Participants were randomly assigned to receive either aripiprazole or placebo, in combination with sodium valproate and quetiapine, for 8 weeks. The primary prespecified endpoint was the mean change in the continuous Yale-Brown Obsessive Compulsive Scale (Y-BOCS) total score from baseline to the week-12 off-treatment follow-up assessment. Data were analyzed using chi-square tests and a linear mixed model (LMM). Results: Forty-six patients (N = 46; 23 per arm) completed the trial. The LMM revealed a highly significant group-by-time interaction for Y-BOCS total scores (P < 0.001), indicating a more favorable trajectory of symptom reduction in the aripiprazole group. At the week-12 off-treatment assessment, the mean reduction from baseline was -8.96 points in the aripiprazole group and -6.13 points in the placebo group; the between-group difference in change from baseline was -2.83 points (95% CI, -4.37 to -1.28; P < 0.001). At week 12, the adjusted between-group difference in Y-BOCS total scores was -1.26 points (95% CI, -4.01 to 1.49), favoring adjunctive aripiprazole. The estimated mean Y-BOCS score at week 12 was 13.17 (95% CI, 11.23 to 15.12) in the aripiprazole group and 14.44 (95% CI, 12.49 to 16.38) in the placebo group. Conclusions: Despite the small sample size and single-center design, these preliminary findings suggest that an 8-week course of adjunctive aripiprazole is well tolerated and may reduce comorbid obsessive-compulsive symptoms in patients with BP-I, with improvement persisting through a 4-week off-treatment follow-up.