Comparative Efficacy and Safety of Adjunctive CT-152 in Patients with Major Depressive Disorder: A Network Meta-Regression

Background: CT-152 received FDA clearance as a prescription digital therapeutic adjunct to antidepressant (ADT) medications for symptoms of major depressive disorder (MDD). A network meta-analysis (NMA) indicated similar efficacy and better safety of adjunctive CT-152 to other adjunctive treatments for MDD. This study aimed to validate the NMA results through network meta-regression (NMR), an advanced analytical method that involves covariates adjustment.
Methods: This Bayesian NMR investigates how adjustment of covariates affects relative treatment effects. The NMR analysis adjusted for covariates such as age, current line of therapy, inadequate response to prior treatments, baseline depression scores, and race to account for demographic differences among trials. The covariates were selected based on clinical relevance and data availability.
Results: Thirty studies assessing 12,830 patients were included. In the NMR, CT-152 demonstrated a similar reduction in MADRS total scores compared to ADTs and atypical antipsychotics (AAPs) across all covariates. For CGI-S, CT-152 was comparable to AAPs, ADTs, and deprexis (a digital therapeutic in market for depression). CT-152 also demonstrated similar efficacy in remission (vs. AAPs, ADTs, and cognitive behavioral therapy) and response rates (vs. AAPs and ADTs). Additional analyses revealed a superior safety profile for CT-152 compared to AAPs and ADTs for any treatment-emergent adverse events.
Conclusion: The NMR analysis upholds the robustness of the NMA for CT-152, suggesting that CT-152 has similar efficacy and improved safety compared to other adjunctive treatments for MDD. Consistent results from various meta-analyses methods further establish CT-152 as a viable treatment for MDD