Poster
170
(#170) Efficacy of brexpiprazole in combination with sertraline on individual symptoms of post-traumatic stress disorder in adults
Psych Congress 2025
Abstract: Post-traumatic stress disorder (PTSD) is a common trauma-based psychiatric disorder. People with PTSD experience a range of heterogenous and complex symptoms, which can vary over time, and cause dysfunction and disability. Response to approved monotherapy treatments can be unsatisfactory. This analysis evaluated the efficacy of brexpiprazole in combination with sertraline on individual PTSD symptoms in adults.
This was a pooled analysis of two flexible-dose, randomized, 12-week, US trials of brexpiprazole+sertraline versus sertraline+placebo in adults with PTSD (Trial 061 [ClinicalTrials.gov: NCT03033069]; Trial 071 [NCT04124614]). Across all arms, the number randomized/completed in each trial was: Trial 061, 231/321 (72.0%); Trial 071, 250/416 (60.1%). The primary efficacy measure was the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5). Least squares (LS) mean change from randomization (Week 1) to Week 10 in CAPS-5 item scores was compared between brexpiprazole+sertraline and sertraline+placebo using mixed models for repeated measures, without adjustment for multiplicity. Data were analyzed regardless of symptom presence at baseline.
Data for 434 patients were analyzed (brexpiprazole+sertraline, n=225; sertraline+placebo, n=209). Mean CAPS-5 Total scores at randomization (Week 1) were 37.5 (brexpiprazole+sertraline) and 37.9 (sertraline+placebo), and LS mean change at Week 10 was -18.0 and -12.7, respectively (data presented previously). On CAPS-5 items, the item with the highest mean score at randomization (Week 1) was sleep disturbance. 19/20 items showed numerically greater improvement at Week 10 with brexpiprazole+sertraline than sertraline+placebo (nominal P 0.05 for 11/20 items).
In a pooled analysis of two trials in adults, brexpiprazole+sertraline was associated with generally greater improvements in individual PTSD symptoms than sertraline+placebo.
Short Description: This is a pooled post hoc analysis of the efficacy of brexpiprazole+sertraline versus sertraline+placebo on individual symptoms of PTSD, based on Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) items, from two flexible-dose trials in adults. Overall, 19/20 items showed numerically greater improvement from randomization (Week 1) to Week 10 with brexpiprazole+sertraline than sertraline+placebo (nominal P 0.05 for 11/20 items).
Name of Sponsoring Organization(s): Otsuka Pharmaceutical Development & Commercialization Inc. (Princeton, NJ, USA) and H. Lundbeck A/S (Valby, Copenhagen, Denmark).
This was a pooled analysis of two flexible-dose, randomized, 12-week, US trials of brexpiprazole+sertraline versus sertraline+placebo in adults with PTSD (Trial 061 [ClinicalTrials.gov: NCT03033069]; Trial 071 [NCT04124614]). Across all arms, the number randomized/completed in each trial was: Trial 061, 231/321 (72.0%); Trial 071, 250/416 (60.1%). The primary efficacy measure was the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5). Least squares (LS) mean change from randomization (Week 1) to Week 10 in CAPS-5 item scores was compared between brexpiprazole+sertraline and sertraline+placebo using mixed models for repeated measures, without adjustment for multiplicity. Data were analyzed regardless of symptom presence at baseline.
Data for 434 patients were analyzed (brexpiprazole+sertraline, n=225; sertraline+placebo, n=209). Mean CAPS-5 Total scores at randomization (Week 1) were 37.5 (brexpiprazole+sertraline) and 37.9 (sertraline+placebo), and LS mean change at Week 10 was -18.0 and -12.7, respectively (data presented previously). On CAPS-5 items, the item with the highest mean score at randomization (Week 1) was sleep disturbance. 19/20 items showed numerically greater improvement at Week 10 with brexpiprazole+sertraline than sertraline+placebo (nominal P 0.05 for 11/20 items).
In a pooled analysis of two trials in adults, brexpiprazole+sertraline was associated with generally greater improvements in individual PTSD symptoms than sertraline+placebo.
Short Description: This is a pooled post hoc analysis of the efficacy of brexpiprazole+sertraline versus sertraline+placebo on individual symptoms of PTSD, based on Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) items, from two flexible-dose trials in adults. Overall, 19/20 items showed numerically greater improvement from randomization (Week 1) to Week 10 with brexpiprazole+sertraline than sertraline+placebo (nominal P 0.05 for 11/20 items).
Name of Sponsoring Organization(s): Otsuka Pharmaceutical Development & Commercialization Inc. (Princeton, NJ, USA) and H. Lundbeck A/S (Valby, Copenhagen, Denmark).
