Johnson & Johnson has released results from a Phase 3 clinical trial evaluating seltorexant, an investigational treatment for adults and elderly patients with major depressive disorder (MDD) who also experience insomnia symptoms. The findings were presented at the U.S. Psychiatric and Mental Health Congress in San Diego.
The 26-week study compared seltorexant to quetiapine extended release (XR), a commonly used adjunctive therapy for MDD patients with insomnia. Seltorexant demonstrated a numerically higher response rate than quetiapine XR—57.4 percent versus 53.4 percent—though this difference did not reach statistical significance for the primary endpoint. Both treatments resulted in significant improvements in depressive symptoms as measured by the Montgomery-Asberg Depression Rating Scale.
Patients treated with seltorexant experienced fewer side effects compared to those receiving quetiapine XR, including lower rates of somnolence (6 percent versus 24 percent) and less weight gain (an average increase of 0.5 kg compared to 2.1 kg). More patients completed the full duration of the study on seltorexant.
“Although the study did not meet its primary endpoint, seltorexant showed efficacy comparable to quetiapine XR, a medication with proven efficacy for MDD that is often associated with notably challenging side effects for patients, such as weight gain and over-sedation. These findings are particularly important, as many patients discontinue treatment due to side effects,” said Andrew Cutler, M.D., Chief Medical Officer at the National Educational Institute and Associate Clinical Professor of Psychiatry at SUNY Upstate Medical Hospital. “Seltorexant has the potential to help address a persistent treatment gap in MDD, particularly for the nearly 60 percent of patients who continue to experience residual insomnia symptoms while on an antidepressant.”
The patient population studied was assessed as moderately-to-severely depressed and had clinically relevant insomnia symptoms. Research indicates that depression and insomnia frequently co-occur; sleep disturbances can worsen depression, creating a cycle that affects quality of life and increases risks such as relapse or suicide.
“With a potential first-in-class mechanism of action, seltorexant represents a promising advancement in the treatment of MDD,” said Bill Martin, Ph.D., Global Therapeutic Area Head, Neuroscience at Johnson & Johnson Innovative Medicine. “Together with existing positive Phase 3 data, these results reinforce the value seltorexant may bring by offering patients meaningful symptom relief without a considerable compromise on tolerability.”
According to the World Health Organization, more than 300 million people worldwide live with depression, making it one of the leading causes of disability globally (https://www.who.int/news-room/fact-sheets/detail/depression). Many individuals with MDD continue to suffer from sleep problems despite current treatments.
Seltorexant is being developed as an adjunctive therapy for adults with MDD experiencing insomnia symptoms. It targets orexin-2 receptors involved in regulating arousal and sleep-wake cycles.
A full list of company-sponsored research presented at Psych Congress is available through Johnson & Johnson’s platforms.
Johnson & Johnson cautioned that these results are based on current expectations and are subject to various risks and uncertainties inherent in pharmaceutical development.