Comparative Efficacy and Safety of Adjunctive CT-152 in Major Depressive Disorder: A Frequentist Network Meta-Analysis
Author(s)
Minyi Lu, PhD1, Barinder Singh, RPh2, Pankaj Rai, MS2, Tarolyn Carlton, PharmD1, Amit Kulkarni, PhD1;
1Otsuka Pharmaceutical Development & Commercialization Inc, Princeton, NJ, USA, 2Pharmacoevidence, SAS Nagar Mohali, India
1Otsuka Pharmaceutical Development & Commercialization Inc, Princeton, NJ, USA, 2Pharmacoevidence, SAS Nagar Mohali, India
Presentation Documents
OBJECTIVES: The FDA has recently approved CT-152 as a prescription digital therapeutic adjunct to antidepressant (ADT) medications for patients with major depressive disorder (MDD). This study aimed to assess the relative efficacy and safety of adjunctive CT-152 compared to other adjunctive treatments.
METHODS: A systematic literature review (SLR) was conducted using PubMed, Cochrane, and Embase to identify randomized controlled trials assessing adjunctive digital, pharmacological, and non-pharmacological treatments in MDD. The review adhered to PRISMA and HTA guidelines, incorporating a two-review and quality control process. Frequentist random-effect (RE) and fixed-effect (FE) network meta-analyses (NMA) were conducted to assess efficacy and safety (at 6 weeks), with sensitivity analyses (SA) addressing heterogeneity and outlier studies.
RESULTS: A total of 30 studies involving 12,830 patients were included. Regarding continuous outcomes, CT-152 showed a similar reduction in MADRS total scores compared to adjunctive ADTs (weighted mean difference, WMD: 0.95) and atypical antipsychotics (AAPs) (WMD: 0.24). CT-152 also demonstrated comparable reductions in CGI-S scores compared to AAPs (WMD: 0.01), ADTs (WMD: -0.33), and deprexis (WMD: -0.20). In terms of categorical outcomes, CT-152 was equally efficacious to other adjunctive treatments regarding remission rates (rate ratio, RR for AAPs: 0.91; RR for ADTs: 1.04; and RR for cognitive behavioral therapy: 1.61). Similarly, for response rate, CT-152 showed comparable results versus AAPs (RR: 1.04) and ADTs (RR: 1.23). Further analyses indicated that CT-152 had a statistically superior safety profile compared to AAPs (odds ratio, OR: 0.32) and ADTs (OR: 0.37) regarding any treatment-emergent adverse events. Bayesian and sensitivity analyses results were aligned with the Frequentist NMA findings.
CONCLUSIONS: CT-152 demonstrated comparable efficacy to adjunctive ADTs, AAPs, and cognitive behavioral therapies while exhibiting a statistically superior safety profile compared to AAPs and ADTs. Consistent findings across various NMA methods reinforce CT-152 as a promising treatment option for MDD.
METHODS: A systematic literature review (SLR) was conducted using PubMed, Cochrane, and Embase to identify randomized controlled trials assessing adjunctive digital, pharmacological, and non-pharmacological treatments in MDD. The review adhered to PRISMA and HTA guidelines, incorporating a two-review and quality control process. Frequentist random-effect (RE) and fixed-effect (FE) network meta-analyses (NMA) were conducted to assess efficacy and safety (at 6 weeks), with sensitivity analyses (SA) addressing heterogeneity and outlier studies.
RESULTS: A total of 30 studies involving 12,830 patients were included. Regarding continuous outcomes, CT-152 showed a similar reduction in MADRS total scores compared to adjunctive ADTs (weighted mean difference, WMD: 0.95) and atypical antipsychotics (AAPs) (WMD: 0.24). CT-152 also demonstrated comparable reductions in CGI-S scores compared to AAPs (WMD: 0.01), ADTs (WMD: -0.33), and deprexis (WMD: -0.20). In terms of categorical outcomes, CT-152 was equally efficacious to other adjunctive treatments regarding remission rates (rate ratio, RR for AAPs: 0.91; RR for ADTs: 1.04; and RR for cognitive behavioral therapy: 1.61). Similarly, for response rate, CT-152 showed comparable results versus AAPs (RR: 1.04) and ADTs (RR: 1.23). Further analyses indicated that CT-152 had a statistically superior safety profile compared to AAPs (odds ratio, OR: 0.32) and ADTs (OR: 0.37) regarding any treatment-emergent adverse events. Bayesian and sensitivity analyses results were aligned with the Frequentist NMA findings.
CONCLUSIONS: CT-152 demonstrated comparable efficacy to adjunctive ADTs, AAPs, and cognitive behavioral therapies while exhibiting a statistically superior safety profile compared to AAPs and ADTs. Consistent findings across various NMA methods reinforce CT-152 as a promising treatment option for MDD.
Conference/Value in Health Info
2025-05, ISPOR 2025, Montréal, Quebec, CA
Value in Health, Volume 28, Issue S1
Code
CO6
Topic
Clinical Outcomes
Disease
No Additional Disease & Conditions/Specialized Treatment Areas, SDC: Mental Health (including addition)