| Mean Baseline |
Mean Change From Baseline to Week 6 |
Adjusted Difference |
|
|---|---|---|---|
| Apparent sadness |
3.8
3.8
|
0.4 | |
| Reported sadness |
4.2
4.2
|
0.5 | |
| Inner tension (anxiety-like symptoms) |
3.2
3.2
|
0.6 | |
| Reduced sleep |
3.9
3.9
|
0.4 | |
| Reduced appetite |
2.3
2.7
|
0.3 | |
| Concentration difficulties |
3.7
3.7
|
0.4 | |
| Lassitude |
3.9
3.9
|
0.3 | |
| Inability to feel |
4.0
4.0
|
0.6 | |
| Pessimistic thoughts |
3.4
3.3
|
0.5 | |
| Suicidal thoughts† |
0.7
0.7
|
0.1 |
Limitations
The analysis of the MADRS individual items was post hoc and was not controlled for Type 1 error. No conclusions of statistical significance can be drawn.
Scores for AUVELITY and the control group were rounded to the nearest tenth for presentation purposes. The difference between groups was calculated using the original, unrounded values.
*mITT population, defined as all randomized patients who took at least 1 dose of study drug and had at least 1 post-baseline assessment.4
†Patients who were considered at risk for suicide were excluded from the trial.4
BID=twice a day; LS=least squares; MADRS=Montgomery-Åsberg Depression Rating Scale; MDD=major depressive disorder; mITT=modified intention-to-treat; SR=sustained release.
Primary Endpoint: LS mean change from baseline in the MADRS total score, calculated at each time point and averaged (overall
treatment effect).1,2
Select secondary endpoint: Percentage of patients achieving MADRS total score of ≤10 at Week 2 (protocol-defined remission).2
Efficacy assessments were performed at weeks 1, 2, 3, 4 and 6 on the mITT population (N=80). The mITT population was defined as all randomized patients who took at least 1 dose of study drug, had at least 1 post-baseline assessment, and whose diagnosis and severity of MDD were confirmed, based on clinical review, by an independent assessor who was blinded to treatment assignment. A total of 17 randomized subjects were excluded from the mITT by the independent assessor.2
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
Key inclusion criteria: male or female 18 to 65 years of age; DSM-5 criteria for current MDD without psychotic features; MADRS total score ≥25; and CGI-S score ≥4 at baseline.2
Key exclusion criteria: bipolar disorder, panic disorder, obsessive-compulsive disorder, treatment-resistant depression (defined as ≥2 failed adequate antidepressant treatments in the current major depressive episode), substance use disorder within the past year, lifetime history of psychotic disorder, clinically significant risk of suicide, and history of seizure disorder.2
BID=twice a day; CGI-S=Clinical Global Impression-Severity; DSM-5=Diagnostic and Statistical Manual of Mental Disorders, 5th Edition; LS=least squares; MADRS=Montgomery-Åsberg Depression Rating Scale; MDD=major depressive disorder; mITT=modified intention-to-treat; SR=sustained-release.
The GEMINI Phase 3 study evaluated AUVELITY vs placebo in 327 patients (n=163 AUVELITY and n=164 placebo) with MDD.3,4
Primary endpoint: LS mean change from baseline in MADRS total score at Week 6.3,4
The ASCEND Phase 2 study evaluated AUVELITY vs bupropion SR 105 mg BID in 80 patients (n=43 AUVELITY and n=37 bupropion) with confirmed MDD.3,5 Primary endpoint: LS mean change from baseline in the MADRS total score, calculated at each time point and averaged (overall treatment effect).3,5
Definitions6
Limitations
The analysis of the MADRS individual items was post hoc and was not controlled for Type 1 error. No conclusions of statistical significance can be drawn.
Limitations
The analysis of the MADRS individual items was post hoc and was not controlled for Type 1 error. No conclusions of statistical significance can be drawn.
Limitations
The analysis of the MADRS individual items was post hoc and was not controlled for Type 1 error. No conclusions of statistical significance can be drawn.
Limitations
The analysis of the MADRS individual items was post hoc and was not controlled for Type 1 error. No conclusions of statistical significance can be drawn.
Limitations
The analysis of the MADRS individual items was post hoc and was not controlled for Type 1 error. No conclusions of statistical significance can be drawn.
Limitations
The analysis of the MADRS individual items was post hoc and was not controlled for Type 1 error. No conclusions of statistical significance can be drawn.
Limitations
The analysis of the MADRS individual items was post hoc and was not controlled for Type 1 error. No conclusions of statistical significance can be drawn.
Limitations
The analysis of the MADRS individual items was post hoc and was not controlled for Type 1 error. No conclusions of statistical significance can be drawn.
Limitations
The analysis of the MADRS individual items was post hoc and was not controlled for Type 1 error. No conclusions of statistical significance can be drawn.
Limitations
The analysis of the MADRS individual items was post hoc and was not controlled for Type 1 error. No conclusions of statistical significance can be drawn.