Takeda Pharmaceutical and H Lundbeck have initiated a Phase III clinical trial for investigational multimodal antidepressant Lu AA21004 in patients with major depressive disorder.
The double-blind, multicentre, randomised trial will involve 360 patients with major depressive disorder and will take place in Japan. It will evaluate the efficacy and safety of the drug in 5mg and 10mg doses compared with a placebo.
The primary endpoint of the trial is to change the score of the Montgomery-Asberg depression rating scale from baseline after eight weeks.
In addition to this study, four short-term and two long-term studies are currently in progress.
In pre-clinical studies, Lu AA21004 enhanced levels of neurotransmitters acetylcholine, dopamine, histamine, noradrenaline and serotonin in the brain.