Significantly more patients taking AUVELITY had symptoms that were
"very much improved"
or "much improved"
at Week 1 vs placebo (P=0.035).
This increase was sustained
at Week 6 (P=0.016).1
P-values for Weeks 2 to 4 were not adjusted for multiplicity and are therefore not presented.
Statistically significant
improvement in
symptom severity at
Week 6 vs placebo
(P=0.002)1
P-values for Weeks 1 to 4 were not adjusted for multiplicity and are therefore not presented.
Depressive symptom severity was measured based on domains such as sleep, mood, and suicidal ideation.3
Limitations: P-values for comparisons were not adjusted for multiplicity and are therefore not presented. No conclusions of statistical significance can be drawn.
Global improvement or worsening of mental illness was measured.4
Limitations: P-values for comparisons were not adjusted for multiplicity and are therefore not presented. No conclusions of statistical significance can be drawn.
*mITT population.
†Missing data were not imputed.
‡Endpoints analyzed using a chi-squared test.
BID=twice a day; CGI-I=Clinical Global Impression-Improvement; mITT=modified intention-to-treat.
*mITT population.
†Missing data were not imputed.
‡Endpoints analyzed using MMRM.
BID=twice a day; CGI-S=Clinical Global Impression-Severity; LS=least squares; MDD=major depressive disorder; mITT=modified intention-to-treat; MMRM=mixed model with repeated measures.
*mITT population.
†Missing data were not imputed.
BID=twice a day; LS=least squares; mITT=modified intention-to-treat; QIDS-SR-16=The Quick Inventory of Depressive Symptomatology-Self-Report (16 items).
*mITT population.
†Missing data were not imputed.
BID=twice a day; mITT=modified intention-to-treat; PGI-I=Patient Global Impression of Improvement.
The CGI-I scale is a clinician-rated scale used to rate total improvement or worsening of mental illness regardless of whether the investigator considers it to be a result of drug treatment or not. The patient is rated on a scale from 1 to 7, with 1 indicating that the patient is very much improved, 2 indicating that the patient has much improved, and 7 indicating that the patient is very much worse.
The CGI-S is a clinician-rated scale used to rate severity of the patient’s current state of mental illness compared with a patient population with MDD. The patient is rated on a scale from 1 to 7, with 1 indicating a normal state and 7 indicating among the most extremely ill patients.
The QIDS-SR-16 is a 16-item, patient-reported, depression scale, which covers the symptom domains of major depressive disorder: mood, concentration, suicidal ideation, loss of interest, loss of energy, insomnia, appetite/weight change, psychomotor agitation/retardation, as well as self-esteem.
The PGI-I scale is a patient-reported scale that is used to rate total improvement or worsening of mental illness since the screening period regardless of a result of drug treatment or not. The patient rates on a scale from 1 to 7, with 1 indicating very much better and 7 indicating very much worse.
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.
*Naïve=patients who have not been on another antidepressant treatment during their current depressive episode.3
Limitations: P-values for comparisons were not adjusted for multiplicity and are therefore not presented. No conclusions of statistical significance can be drawn.
Limitations: P-values for comparisons were not adjusted for multiplicity and are therefore not presented. No conclusions of statistical significance can be drawn.