MADRS individual items: pooled, post hoc analysis from GEMINI and ASCEND

AUVELITY showed a numerical decrease across all item scores at Week 6 vs control1*

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.

Post hoc Analysis: Additional Information
Footnotes and Definitions
References

Post hoc Analysis: Additional Information

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

  • Apparent sadness: despondency, gloom, and despair (more than just ordinary transient low spirits) reflected in speech, facial expression, and posture
  • Reported sadness: reports of depressed mood, regardless of whether it is reflected in appearance or not. Includes low spirits, despondency, or the feeling of being beyond help and without hope
  • Inner tension: feelings of ill-defined discomfort, edginess, inner turmoil, mental tension mounting to either panic, dread, or anguish
  • Reduced sleep: experience of reduced duration or depth of sleep compared to the subject's own normal pattern when well
  • Reduced appetite: feeling of a loss of appetite compared with when well
  • Concentration difficulties: difficulties in collecting one's thoughts mounting to incapacitating lack of concentration
  • Lassitude: difficulty getting started or slowness initiating and performing everyday activities
  • Inability to feel: subjective experience of reduced interest in the surroundings or activities that normally give pleasure. The ability to react with adequate emotion to circumstances or people is reduced
  • Pessimistic thoughts: thoughts of guilt, inferiority, self-reproach, sinfulness, remorse, and ruin
  • Suicidal thoughts†: feeling that life is not worth living, that a natural death would be welcome, suicidal thoughts, and preparations for suicide. Suicidal attempts should not in themselves influence the rating