The week-8 response rate as reflected in at least a 50% improvement from baseline in MADRS
score was 61.
Brintellix was statistically superior to placebo on the MADRS
total score reduction of at least 50% was achieved in 42% of the levomilnacipran SR group compared with 29% of controls.
The HAMD-S and MADRS
scales, however, have not been validated as somatic subscales, Dr.
The Phase IIa study of Serdaxin demonstrated in a subset of severely depressed patients a statistically significant reduction in MADRS
scores compared to placebo at the 5 mg dose," said Dr.
Patients also report improvements in health-related quality of life measures such as 'seizure worry' and 'cognitive function' as well as improvement in the MADRS
(Montgomery-Asberg Depression Rating Scale) depressive symptoms scale.
Major finding: MADRS
scores improved significantly within 24 hours in 64% of patients treated with ketamine and in 28% treated with midazolam.
Both 15 mg and 20 mg doses of vortioxetine were statistically significantly superior to placebo in mean change from baseline in MADRS
total score at Week 8, with a mean treatment difference to placebo (n=158) of -5.
is a standardized, rater-administered scale, which has been used for numerous drug trials in bipolar disorder.
Ehrich said, adding that the patterns on MADRS
scores were similar with both ratios, but "every patient on the full blockade ratio demonstrated a response.
The primary objective of this study is to assess the safety and efficacy of RG2417 on the symptoms of bipolar depression by demonstrating a greater improvement in the MADRS
score of the patients receiving RG2417 when compared to placebo over the 8-week treatment period.
The primary endpoint was defined as change from randomization baseline to end of Week 8 in the MADRS