This poster was presented at the 29th Annual U.S. Psychiatric & Mental Health Congress, held October 21-24, 2016, in San Antonio, Texas.
OBJECTIVES: Many patients with pseudobulbar affect (PBA) are treated concomitantly with antidepressants. This exploratory analysis evaluated outcomes from a DM/Q effectiveness trial for PBA stratified by antidepressant use at baseline.
METHODS: In the open-label PRISM II study, persons with PBA secondary to dementia, stroke, or traumatic brain injury (TBI) and a Center for Neurologic Study Lability Scale (CNS-LS) Score ≥13 were treated with DM/Q 20/10 mg BID for 90 days. Patients taking stable dosages of antidepressants were eligible. Outcome measures included CNS-LS score, PBA episode counts, QoL-Visual Analog Scale, PHQ-9, and MMSE. LS mean change from baseline to Day 90 for antidepressant users vs non-users were analyzed for each cohort (TBI, dementia, and stroke) using ANCOVA with baseline score as a covariate. Adverse events (AEs) were recorded.
RESULTS: A total of 367 patients enrolled, including 120, 113, and 134, with TBI, stroke, and dementia, respectively. Of these, 48.5% [42.5%, 45.1%, and 56.7%, respectively] were using antidepressants. Significant improvements were observed for all outcome measures, regardless of antidepressant use. All outcome measures were similar for antidepressant users vs non-users and within disease cohorts, except MMSE in the stroke cohort [0.5, antidepressant users vs 1.7, nonusers, P=.02]. AEs were reported for 37.6% of antidepressant users and 34.4% of non-users. Serious AEs were reported for 5.6% vs 6.9% and discontinuations due to AEs for 7.9% vs 11.6% of users vs non-users.
CONCLUSIONS: In this analysis, DM/Q was associated with PBA symptom improvement and reduced depressive symptoms, regardless of concomitant antidepressant use at baseline.