This study is exploring whether a weekly injection of an investigational medicine, taken with regular antidepressant medication, can help delay the return of major depressive disorder (MDD) symptoms. It is for adults aged 18 to 75 who are currently in remission or near remission but still experience some ongoing symptoms.
Major depressive disorder (MDD) is a common mental health condition that can return even after successful treatment, affecting daily functioning and overall well-being.
This study is evaluating the safety and effectiveness of an investigational once-weekly injectable treatment for adults with MDD who are in remission or near remission but still have some remaining symptoms. The investigational medicine is being studied to see if it can help delay relapse, support ongoing recovery, and improve long-term outcomes when given alongside regular antidepressant medication.
You may be eligible if:
If eligible, participants will be on the study for several months. The study includes screening, baseline, treatment, and follow-up phases. Screening and baseline visits each last about 3-4 hours. Treatment visits occur every 4 weeks and last about 2-3 hours, with follow-up visits lasting 2-3 hours. Between some visits, there will be short phone calls of about 15 minutes.
During the treatment period, participants will be randomly assigned to receive either the investigational medicine or placebo, given once weekly by injection in the abdomen, thigh, or upper arm. Some visits will require fasting for at least 8 hours, with water permitted.
Participants will complete health assessments including blood tests (up to 10 in total), ECGs, and mental health questionnaires. They will also be asked to keep a diary throughout the study. This is a double-blind study, meaning neither participants nor the study team will know whether the investigational medicine or placebo is being given.
All visits take place in a supportive environment, and a 190 dollar reimbursement per visit for time and travel will be provided.
