SUMMARY

• A subgroup analysis of SUSTAIN-3 (NCT02782104) assessed the long-term safety and efficacy of SPRAVATO + oral antidepressant (AD) in 41 Black and/or African American (AA) patients diagnosed with treatment-resistant depression (TRD).^1-3
  • The most common treatment-emergent adverse events (TEAEs) were dizziness (31.7%), dissociation (26.8%), and nausea (24.4%).
  • Mean (SD) changes in Montgomery-Asberg Depression scale (MADRS), Sheehan Disability Scale (SDS), and Patient Health Questionnaire (PHQ-9) scores during the induction (IND) phase were -11.9 (11.06), -4.2 (10.54), and -5.3 (6.88), respectively.
  • Improvements observed at the end of the IND phase were generally maintained throughout the optimization/maintenance (OP/M) phase.
• Safety and efficacy results observed in Black and/or AA patients were consistent with the overall SUSTAIN-3 patient population.^1-3

CLINICAL DATA

Harding et al (2022)¹ presented data from the subgroup analysis of SUSTAIN-3 (NCT02782104) that assessed the long-term safety and efficacy of SPRAVATO + oral AD in Black and/or AA patients (n=41) diagnosed with TRD.^2,3

Study Design/Methods

• Subgroup analysis of SUSTAIN-3, an ongoing, open-label, multicenter, phase 3 extension study.
• Patients (aged 18-64 years) who participated in ≥1 of the 5 parent studies and entered the SUSTAIN-3 study during the 4-week IND or during the variable duration OP/M phase were included.
• During the IND phase, patients received SPRAVATO 56 or 84 mg twice weekly, whereas, in the OP/M phase, patients received flexibly dosed SPRAVATO. An oral AD was coadministered during the IND and OP/M phases.

Results

Baseline Characteristics

• As of December 2020, 41 Black and/or AA patients were included in the subgroup analysis. The mean age was 47.3 years; 68.3% were female; 90.2% were non-Hispanic/Latino; and 31.7% patients had ≥36 months of SPRAVATO exposure.

Safety

• The most common TEAEs were dizziness (31.7%), dissociation (26.8%), and nausea (24.4%). Most TEAEs were mild or moderate in severity. Most adverse events (including dissociation, sedation, nausea, and elevated blood pressure) occurred on the day of dosing, and resolved on the same day.

Efficacy

• Mean MADRS, SDS, and PHQ-9 scores at IND baseline were 29.9, 17.4, and 14.5, respectively, and mean (SD) changes during IND phase were -11.9 (11.06), -4.2 (10.54), and -5.3 (6.88), respectively. These improvements were generally maintained during the OP/M phase.

Literature Search

A literature search of MEDLINE^®, Embase^®, BIOSIS Previews^®, and Derwent Drug File databases (and/or other resources, including internal/external databases) pertaining to this topic was conducted on 19 August 2024.