Discussion
Sexual dysfunction, anhedonia, anxiety, TEAEs, hypomanic/manic, Psychiatric disorders, psychosis, psychiatric, MDD
SIDE EFFECT, DISORDERS, ADVERSE EFFECTS, SECONDARY, REMISSION
On the primary outcome measure of changes from baseline in MADRS total score, the superiority of both dosages of ansofaxine to placebo was statistical significance, with a prominent mean treatment difference of −5.46 points for 80 mg/day and −5.06 points for 160 mg/day. However, the change in the total MADRS score from baseline in the placebo group was 14.6 points, which was slightly higher than usual. The reduction compared with placebo is much greater than the two-point average for approved antidepressants [Response rate is also frequently used as a measure of clinical relevance, and a average of approximately 15% difference between drug and placebo is regarded as sufficient to establish antidepressant treatment advantage [Similarly, treatment with ansofaxine was associated with a statistically significant greater MADRS remission rate (MADRS total score ≤10) of 51.63% and 52.17% in the 80 mg and 160 mg groups, respectively (The results are much higher than the moderate response rate of 40%–60% and low remission rate demonstrated by many first-line or widely prescribed antidepressants [Significant differences versus placebo were consistently observed across secondary and additional efficacy measures in treatment groups. Improvement in HAM-DAnsofaxine showed a beneficial effect on symptoms of anxiety in patients with MDD over placebo, as demonstrated by a decrease of HAMA total score of 11.5 (80 mg/day) and 11.1 (160 mg/day) throughout the 8-week treatment period (A predicament for treatment in patients with MDD is the common symptom and critical diagnostic criterion of anhedonia, a predictor of non-response to plenty of antidepressants [It was observed that changes from baseline to the end of week 8 in SDS score were significantly greater for ansofaxine, with the inter-group difference Treatment with ansofaxine was generally safe and well tolerated in this trial, and TEAEs were mild to moderate in severity in most cases. No new safety findings were observed, and no new, unexpected, drug-related, serious AEs occurred with ansofaxine therapy. The incidence of TEAEs was similar to the data in a meta-analysis [Ansofaxine 80 and 160 mg did not increase suicide risks compared to the placebo group. There was no significant difference in laboratory tests and weight in the ansofaxine 80 mg/day and 160 mg/day group compared with the placebo. No clinically relevant changes were observed in 12-lead ECG and vital signs parameters.Sexual dysfunction, a frequent side effect of drugs with serotonin reuptake inhibitor properties, is a common reason for therapeutic discontinuation. It had been reported that the prevalence of sexual dysfunctions in patients on antidepressants was two times higher than that in patients on control (50% Psychiatric disorders, such as hypomanic/manic, psychosis, is an adverse effects of the drug in people receiving antidepressant therapy. However, AEs related to psychiatric disorders were mild or moderate,while hypomanic/manic or psychosis cases were not collect in our clinical trial. The incidence of hypomanic/manic or psychosis depends on the study sample characteristics (inpatient vs. outpatient populations), antidepressant class (studies with TCAs or MAOIs monotherapy reported higher rates), diagnostic criteria (DSM vs. Research Diagnostic Criteria), and study duration (studies with longer follow-up reported higher rates) [In conclusion, the results of this trial demonstrate that both dosages of ansofaxine 80 mg and 160 mg are safe, generally well tolerated, and remarkably effective at a clinically relevant level for the treatment of MDD.