The multicenter, double-blind, placebo-controlled study is designed to evaluate the efficacy and overall safety and tolerability of ADX71149 as an adjunctive treatment to an antidepressant in 94 adults with major depressive disorder with anxiety symptoms.
ADX71149 is also being studied in a Phase 2 trial for the treatment of positive and negative symptoms of schizophrenia.
Addex CEO Bharatt Chowrira said the initiation of the second Phase 2 study is an indication of the potential for ADX71149 to treat more than one psychiatric disorder.
Oral ADX71149 will be administered twice-daily at doses ranging from 2mg to 150mg. Patients will continue to take the same daily dose of their antidepressant.
The change from baseline in the Hamilton Anxiety Rating scale (HAM-A6) score will be the primary endpoint of the study.
The change from baseline of several other clinician-administered rating scales designed to assess the severity of depression and anxiety symptoms are the secondary endpoints.