Change in function scores from Week 1 to Week 6¹

Change in Sheehan Disability Scale (SDS)¹*^†

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

Limitations
P-values for comparisons were not adjusted for multiplicity and are therefore not presented. Conclusions of statistical significance cannot be drawn.

^‡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.

Reference

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 trial^1,2

Not actual patients.

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

~75% of patients were treatment-naïve during their current depressive episode (in GEMINI and ASCEND trials, n=397)³*

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.

*Naïve=patients who have not been on another antidepressant treatment during their current depressive episode.³

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.
Jones A, O'Gorman C, Clayton AH, Tabuteau H. Analysis of efficacy of AXS-05 in the treatment of major depressive disorder based on gender, race, and prior antidepressant use. Poster presented at: ISCTM Annual Meeting 2021; April 6–9, 2021.

Change in function scores from Week 1 to Week 61

Change in Sheehan Disability Scale (SDS)1*†

Footnotes and Definitions

References

GEMINI Phase 3 Study Design1

Efficacy Assessments

Footnotes and Definitions

Reference

Patients with moderate to severe MDD were evaluated in the GEMINI trial1,2

~75% of patients were treatment-naïve during their current depressive episode (in GEMINI and ASCEND trials, n=397)3*

Footnotes and Definitions

References

Change in Sheehan Disability Scale (SDS)1*†

Change in function scores from Week 1 to Week 6¹

Change in Sheehan Disability Scale (SDS)¹*^†

GEMINI Phase 3 Study Design¹

Patients with moderate to severe MDD were evaluated in the GEMINI trial^1,2

~75% of patients were treatment-naïve during their current depressive episode (in GEMINI and ASCEND trials, n=397)³*

Change in Sheehan Disability Scale (SDS)¹*^†