Ammoxetine for major depressive disorder clears phase II study

In the treatment of patients with major depressive disorder (MDD), ammoxetine is well tolerated and shows superior efficacy relative to placebo, as shown in a phase II study conducted in China.

The study included 239 adult patients with MDD (mean age 30.4 years, 66.1 percent female). They were randomly assigned to receive ammoxetine at 40 mg/d (n=80) or 60 mg/d (n=80) or placebo (n=79).

Change in Montgomery-Åsberg Depression Rating Scale (MADRS) total score from baseline to 8 weeks was assessed as the primary endpoint. Safety was also evaluated.

In the full-analysis set, MADRS total scores at week 8 significantly improved with ammoxetine than with placebo. The least square mean changes in MADRS total scores from baseline were −16.7 with ammoxetine 40 mg/d, −16.6 with the 60-mg/d dose, and −13.5 with placebo. The corresponding differences vs placebo were −3.3 (97.3 confidence interval [CI], −6.3 to −0.3) with ammoxetine 40 mg/d and −3.1 (97.3 percent CI, −6.2 to 0.0) with the 60-mg/d dose.

Results were consistent in the per-protocol set analysis. The differences in the least square mean change in MADRS total scores at week 8 relative to placebo were −3.2 (97.3 percent CI, −6.2 to −0.2) with ammoxetine 40 mg/d and −3.18 (97.3 percent CI, −6.2 to −0.2) with the 60-mg/d dose.

In terms of safety, treatment-emergent adverse events occurred in 85 percent of patients on ammoxetine 60 mg/d, 78.8 percent of those on ammoxetine 40 mg/d, and 60.8 percent of those on placebo. Most of these events were mild to moderate in severity.