Study of Low-Dose Buprenorphine Added to Usual Treatment for Reducing Severe Suicidal Thoughts in Adults with Major Depression

What this Trial Is About

Researchers are studying whether adding low doses of buprenorphine to usual treatment can help reduce severe suicidal thoughts in people experiencing a major depressive episode. The study is a phase 3 randomized clinical trial comparing two doses of buprenorphine 0.4 mg and 0.8 mg with placebo to determine the most effective dose. It focuses on patients with high depression and suicidal ideation scores who are hospitalized or in consultation. Participants will be randomly assigned to receive either placebo pills or buprenorphine pills sublingually for 21 days, followed by a 7-day withdrawal period. The treatment groups include daily doses of 0.4 mg or 0.8 mg buprenorphine with specific dosing schedules over 28 days. Two follow-up phone calls will occur at 3 and 6 months to check for any suicidal behavior. During the study, researchers will assess changes in suicidal thoughts using the Beck Scale for Suicidal Ideation during the first week and over 28 days. They will also measure depression levels, psychological pain, side effects, withdrawal symptoms, and neuropsychological and brain imaging changes. Blood and stool samples will be collected at four time points and stored for future research. The total study duration includes treatment, withdrawal, and follow-up assessments over six months.

Add-on Buprenorphine at Analgesic Doses for the Treatment of Severe Suicidal Ideas During a Major Depressive Episode