Poster
169
(#169) Effect of brexpiprazole in combination with sertraline on post-traumatic stress disorder symptom clusters: intrusion, avoidance, negative cognitions/mood, and arousal/reactivity
Psych Congress 2025
Abstract: Symptoms of post-traumatic stress disorder (PTSD) can be characterized into four clusters. This post hoc analysis evaluated the efficacy of brexpiprazole in combination with sertraline on PTSD symptom clusters in adults, using Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) data.
Trials 061 (ClinicalTrials.gov identifier: NCT03033069), 071 (NCT04124614), and 072 (NCT04174170) evaluated brexpiprazole+sertraline versus sertraline+placebo for PTSD in adults. The primary efficacy endpoint was change from randomization (Week 1) to Week 10 in CAPS-5 Total score. In three pools (All trials [071, 061, 072]; Flexible-dose trials [071, 061]; Phase 3 trials [071, 072]), least squares (LS) mean change in each CAPS-5 symptom cluster score was compared for brexpiprazole+sertraline and sertraline+placebo (mixed model for repeated measures without adjustment for multiplicity; P-values are nominal).
Across the pools (All, n=820; Flexible-dose, n=434; Phase 3, n=668), LS mean change from randomization (Week 1) to Week 10 in CAPS-5 Intrusion score ranged from -5.04 to -5.11 with brexpiprazole+sertraline, and -3.22 to -4.23 with sertraline+placebo (Week 10 comparison: All, P=0.0002; Flexible-dose, P 0.0001; Phase 3, P=0.017). Change in Avoidance score: brexpiprazole+sertraline, -2.14 to -2.21; sertraline+placebo, -1.45 to -1.89 (All, P=0.015; Flexible-dose, P=0.0015; Phase 3, P=0.18). Change in Negative cognitions and mood score: brexpiprazole+sertraline, -6.82 to -6.95; sertraline+placebo, -4.98 to -5.98 (All, P=0.0037; Flexible-dose, P=0.0011; Phase 3, P=0.037). Change in Arousal and reactivity score: brexpiprazole+sertraline, -3.83 to -4.06; sertraline+placebo, -2.87 to -3.23 (All, P=0.0095; Flexible-dose, P=0.0088; Phase 3, P=0.0076).
In pooled analyses of adult trials, brexpiprazole+sertraline was associated with greater improvements in the four PTSD symptom clusters than sertraline+placebo.
Short Description: This is a pooled post hoc analysis of brexpiprazole+sertraline versus sertraline+placebo on symptom clusters of PTSD, based on the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5), from three trials in adults. CAPS-5 symptom cluster data were analyzed across three different pools; all three trials, the two flexible-dose trials, and the two Phase 3 trials. On each CAPS-5 symptom cluster, brexpiprazole+sertraline was associated with improvements in PTSD symptom severity and functioning compared with sertraline+placebo.
Name of Sponsoring Organization(s): Otsuka Pharmaceutical Development & Commercialization Inc. (Princeton, NJ, USA) and H. Lundbeck A/S (Valby, Copenhagen, Denmark).
Trials 061 (ClinicalTrials.gov identifier: NCT03033069), 071 (NCT04124614), and 072 (NCT04174170) evaluated brexpiprazole+sertraline versus sertraline+placebo for PTSD in adults. The primary efficacy endpoint was change from randomization (Week 1) to Week 10 in CAPS-5 Total score. In three pools (All trials [071, 061, 072]; Flexible-dose trials [071, 061]; Phase 3 trials [071, 072]), least squares (LS) mean change in each CAPS-5 symptom cluster score was compared for brexpiprazole+sertraline and sertraline+placebo (mixed model for repeated measures without adjustment for multiplicity; P-values are nominal).
Across the pools (All, n=820; Flexible-dose, n=434; Phase 3, n=668), LS mean change from randomization (Week 1) to Week 10 in CAPS-5 Intrusion score ranged from -5.04 to -5.11 with brexpiprazole+sertraline, and -3.22 to -4.23 with sertraline+placebo (Week 10 comparison: All, P=0.0002; Flexible-dose, P 0.0001; Phase 3, P=0.017). Change in Avoidance score: brexpiprazole+sertraline, -2.14 to -2.21; sertraline+placebo, -1.45 to -1.89 (All, P=0.015; Flexible-dose, P=0.0015; Phase 3, P=0.18). Change in Negative cognitions and mood score: brexpiprazole+sertraline, -6.82 to -6.95; sertraline+placebo, -4.98 to -5.98 (All, P=0.0037; Flexible-dose, P=0.0011; Phase 3, P=0.037). Change in Arousal and reactivity score: brexpiprazole+sertraline, -3.83 to -4.06; sertraline+placebo, -2.87 to -3.23 (All, P=0.0095; Flexible-dose, P=0.0088; Phase 3, P=0.0076).
In pooled analyses of adult trials, brexpiprazole+sertraline was associated with greater improvements in the four PTSD symptom clusters than sertraline+placebo.
Short Description: This is a pooled post hoc analysis of brexpiprazole+sertraline versus sertraline+placebo on symptom clusters of PTSD, based on the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5), from three trials in adults. CAPS-5 symptom cluster data were analyzed across three different pools; all three trials, the two flexible-dose trials, and the two Phase 3 trials. On each CAPS-5 symptom cluster, brexpiprazole+sertraline was associated with improvements in PTSD symptom severity and functioning compared with sertraline+placebo.
Name of Sponsoring Organization(s): Otsuka Pharmaceutical Development & Commercialization Inc. (Princeton, NJ, USA) and H. Lundbeck A/S (Valby, Copenhagen, Denmark).
