Improvement in function scores from Week 1 to Week 6¹

Sheehan Disability Scale
(SDS) scores vs placebo¹*^†

What does the SDS scale measure?²

The Sheehan Disability Scale measures functional disability and impairment through the following patient-reported criteria:

School/work^‡

Social life

Family life/home responsibilities

P-values for comparisons were not adjusted for multiplicity and are therefore not presented.

^‡Work includes paid work, unpaid volunteer work, or training.²

GEMINI Phase 3 Study Design¹

Primary Endpoint¹

LS mean change from baseline in MADRS total score at Week 6.

Key Secondary Endpoints¹

LS mean change in MADRS total score from baseline at Week 1
LS mean change in MADRS total score from baseline at Week 2
Percentage of patients achieving response (≥50% reduction in MADRS total score from baseline) at Week 6
Percentage of patients achieving remission (MADRS total score ≤10) at Week 2

Other Secondary Endpoints¹

Clinical Global Impression-Improvement (CGI-I)
Clinical Global Impression-Severity (CGI-S)
Quality of Life Enjoyment and Satisfaction Questionnaire‑Short Form (Q‑LES‑Q‑SF)
Sheehan Disability Scale (SDS)
Patient Global Impression of Improvement (PGI‑I)
Quick Inventory of Depressive Symptomatology‑Self‑Report (16 items) (QIDS‑SR‑16)

Efficacy Assessments

Efficacy assessments were performed at Weeks 1, 2, 3, 4, and 6 on the mITT population. The mITT population was defined as all randomized patients who took at least 1 dose of study drug and had at least 1 post-baseline assessment. Examination of demographic subgroups by age, sex, and race did not suggest differences on the primary endpoint.¹

Footnotes and Definitions

BID=twice a day; LS=least squares; MADRS=Montgomery-Åsberg Depression Rating Scale; mITT=modified intention-to-treat.

References

losifescu DV, Jones A, O'Gorman C, et al. Efficacy and safety of AXS-05 (dextromethorphan-bupropion) in patients with major depressive disorder: a phase 3 randomized clinical trial (GEMINI). J Clin Psychiatry. 2022;83(4):21ml4345.

Patients with moderate to severe MDD were evaluated in the GEMINI trial¹

Not actual patients.

Demographic and baseline disease characteristics were generally similar across both treatment groups

Footnotes and Definitions

AA=African American; BID=twice a day; BMI=body mass index; MADRS=Montgomery-Åsberg Depression Rating Scale; MDD=major depressive disorder; PHQ-9=Patient Health Questionnaire-9.

References

losifescu DV, Jones A, O'Gorman C, et al. Efficacy and safety of AXS-05 (dextromethorphan-bupropion) in patients with major depressive disorder: a phase 3 randomized clinical trial (GEMINI). J Clin Psychiatry. 2022;83(4):21ml4345.
Hawley CJ, Gale TM, Smith PS, et al. Equations for converting scores between depression scales (MADRS, SRS, PHQ-9 and BDI-II): good statistical, but weak idiographic, validity. Hum Psychopharmacol. 2013;28:544-551.

Improvement in function scores from Week 1 to Week 61

Sheehan Disability Scale (SDS) scores vs placebo1*†

Footnotes and Definitions

References

GEMINI Phase 3 Study Design1

Efficacy Assessments

Footnotes and Definitions

References

Patients with moderate to severe MDD were evaluated in the GEMINI trial1

Footnotes and Definitions

References

Sheehan Disability Scale(SDS) scores vs placebo1*†

Improvement in function scores from Week 1 to Week 6¹

Sheehan Disability Scale
(SDS) scores vs placebo¹*^†

GEMINI Phase 3 Study Design¹

Patients with moderate to severe MDD were evaluated in the GEMINI trial¹

Sheehan Disability Scale
(SDS) scores vs placebo¹*^†