The study of anti-suicidal effects of buprenorphine in depressed individuals
New York State Psychiatric Institute is recruiting patients for the clinical trial of Anti-suicidal Effects of Buprenorphine In Depressed Individuals.
This study aims to examine the effect of low-dose buprenorphine as an add-on to treatment-as-usual for suicidal ideation in individuals with major depression, and investigate the functional brain activity related to its potential anti-suicidal effect.
Buprenorphine is an approved treatment for pain and opioid relapse prevention. Buprenorphine has recently shown promise in the treatment of depression and suicidal ideation relatively faster than currently available antidepressants, but its mechanisms in treating these conditions are unknown. Buprenorphine activates the mu opioid receptor in the brain and blocks the kappa opioid receptor. Activation of the mu receptors produces pleasant emotions while the kappa receptors are linked to dysphoria and other negative emotional states. By blocking kappa receptors, buprenorphine may reduce negative emotions and improve suicidal thoughts.
In this project, we will compare buprenorphine to placebo as adjunctive to usual treatments for patients who still have depression and suicidal thoughts despite being treated with adequate antidepressant medications for at least 4 weeks.
We hypothesize that suicidal ideation will decrease after two weeks of treatment in the buprenorphine group relative to the placebo group. Using functional magnetic resonance imaging, we will also examine the effects of buprenorphine on the activity of brain regions involved in the brain's response to negative emotions and test whether these effects are associated with the reduction in suicidal thoughts.
The researchers plan that July 1, 2022 will be the study start date. The indicative completion of the clinical trial will be expected in June 30, 2023.
Among primary outcome measures are the Changes in Beck Scale for Suicidal Ideation (SSI) scores from pre- to Week 2 post-treatment and Clinician-based questionnaire measuring level of suicidal ideas over the last 7 days; 21 items scored 0 to 2; total score ranges from 0 to 38 (last 2 items not counted), higher scores mean more intense suicidal ideas.
The page dedicated to this clinical trial can be found here: https://ichgcp.net/clinical-trials-registry/NCT05427981 or https://clinicaltrials.gov/ct2/show/NCT05427981.
