Data from open-label studies have limitations. As the study was not blinded or placebo-controlled, results should be interpreted with these factors in mind. Endpoints were analyzed descriptively, and statistical significance cannot be attributed.
All newly enrolled patients were assessed for efficacy through Week 6. Only patients whose MADRS scores improved by ≥25% were eligible to continue in the study. 6% of subjects met discontinuation criteria at Week 6.
Presentation of GEMINI results are for contextual purposes only. Comparisons of the data cannot be made due to the disparate nature of the study designs.
The decrease in patient number over time in COMET is primarily due to staggered entry into the study and the closing of the study once enrollment goals were met.
Data from open-label studies have limitations. As the study was not blinded or placebo-controlled, results should be interpreted with these factors in mind. Endpoints were analyzed descriptively, and statistical significance cannot be attributed.
All newly enrolled patients were assessed for efficacy through Week 6. Only patients whose MADRS scores improved by ≥25% were eligible to continue in the study. 6% of subjects met discontinuation criteria at Week 6.
The decrease in patient number over time in COMET is primarily due to staggered entry into the study and the closing of the study once enrollment goals were met.
Baseline mean SDS total score was 20.0 (SD=5.8).2
*AUVELITY-naive ITT population.
†Missing data were not imputed. Efficacy data from early termination visits were included in the summary of the next scheduled efficacy assessment visit.
‡Endpoints analyzed using a chi-squared test.
BID=twice a day; CGI-I=Clinical Global Impression-Improvement; ITT=intention-to-treat; MADRS=Montgomery-Åsberg Depression Rating Scale.
*Auvelity-naive ITT population.
†Missing data were not imputed. Efficacy data from early termination visits were included in the summary of the next scheduled efficacy assessment visit.
BID=twice a day; ITT=intention-to-treat; MADRS=Montgomery-Åsberg Depression Rating Scale; SD=standard deviation; SDS=Sheehan Disability Scale.
LS mean change from baseline in MADRS total score at Week 6.
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
BID=twice a day; LS=least squares; MADRS=Montgomery-Åsberg Depression Rating Scale; mITT=modified intention-to-treat.
Not actual patients.
Demographic and baseline disease characteristics were generally similar across both treatment groups
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.
COMET was a Phase 3, multicenter, open-label US study. Patients with MDD were treated with AUVELITY twice daily in a 12-month study.
The study enrolled both patients completing a prior AUVELITY study and newly enrolled patients. The trial was concluded once at least 300 patients had been treated for 6 months and at least 100 patients had been treated for 12 months, as prespecified. At the time of study conclusion, 597 patients had reached at least 6 months, and 110 patients had reached at least 12 months of treatment.1-3
Efficacy endpoint results were based on the newly enrolled patients (n=609) and the safety results from the full population (N=876).4,6
All newly enrolled patients were assessed for efficacy through Week 6. Only patients whose MADRS scores improved by ≥25% were eligible to continue in the study. 6% of subjects met discontinuation criteria at Week 6.1,7
Select secondary endpoints include: Clinical remission (MADRS total score ≤10), clinical response (≥50% improvement in MADRS total score from baseline), CGI-I, and SDS.1
Clinical response and clinical remission were assessed on the MADRS scale. The MADRS is a clinician-rated scale used to assess depressive symptom severity. Patients are rated on 10 items to assess feelings of sadness, inner tension, reduced sleep or appetite, difficulty concentrating, lassitude, lack of interest, pessimism, and suicidality. Scores range from 0 to 60, with higher scores indicating more severe depression.1,5
BID=twice a day; CGI-I=Clinical Global Impression-Improvement; MADRS=Montgomery-Åsberg Depression Rating Scale; MDD=major depressive disorder; SDS=Sheehan Disability Scale.
The decrease in patient number over time in COMET is primarily due to staggered entry into the study and the closing of the study once enrollment goals were met.
What does the SDS scale measure?4
The Sheehan Disability Scale measures functional disability and impairment through the following criteria:
School/work‡
Social life
Family life/home responsibilities
‡Work includes paid work, unpaid volunteer work, or training.