Evaluation of Seltorexant as a Single Treatment for Adults and Older Adults with Major Depressive Disorder Including Long-Term Safety and Tolerability Assessment

What this Trial Is About

Researchers are evaluating the study drug JNJ-42847922, also called seltorexant, in adults and older adults with major depressive disorder MDD, a mood disorder causing lasting sadness and loss of interest. The study aims to compare seltorexant with a placebo in improving depressive symptoms during a double-blind treatment phase and to assess the long-term safety and tolerability of seltorexant in an open-label phase. Participants will receive either seltorexant or a matching placebo tablet once daily for 42 days during the double-blind phase. Those who qualify for the open-label phase will then take seltorexant daily for up to six months. The treatments are oral tablets, and the study includes two main periods the initial 42-day double-blind phase and the subsequent long-term open-label phase. During the study, participants will have regular assessments including physical exams, vital signs, ECGs, and questionnaires on depression, sleep disturbance, suicidality, withdrawal symptoms, sexual functioning, body measurements, and laboratory tests. Researchers will measure changes in depression scores and monitor adverse events and safety indicators throughout both phases. The total participation can last up to about seven months including both treatment periods.

A Study of Seltorexant as Monotherapy in Adults and Elderly Participants With Major Depressive Disorder