At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Incomplete Response in Late-Life Depression: Getting to Remission With Buprenorphine
In Brief
A Phase 2 clinical trial evaluating venlafaxine XR, buprenorphine, and 1 other intervention for Major Depressive Disorder and Depression. Completed, enrolled 18 participants across 1 site.
Detailed Summary
The investigators are conducting a research study to learn about the safety and benefit of using a medication called buprenorphine for patients with difficult to treat depression. This research study is testing whether combining two medications will be effective in treating depression when initial treatment with just one antidepressant does not relieve the depressive symptoms; this is what is called "difficult to treat depression" or "treatment resistant depression". The two medications the investigators are using are: an anti-depressant medication called venlafaxine extended release (venlafaxine XR), which is the generic form of Effexor, and buprenorphine. Buprenorphine is a medication that is FDA approved for the treatment of opioid dependence. The investigators are testing whether adding buprenorphine to venlafaxine XR enhances treatment response.
Study Details
Timeline
Interventions
slow titration up to maximum dose of 300mg per day, will remain on venlafaxine XR for up to 32 weeks
randomized to either buprenorphine or placebo, dose range from 0.2 mg/ qd to 2mg/ qd
patients will remain on venlafaxine XR and be randomized to receive either placebo or buprenorphine for 8 weeks. at the end of the 8 weeks those who did not receive buprenorphine will be offered the opportunity to try it.