To help patients living with difficult to treat depression, researchers at the University of Pittsburgh are seeking participants for a clinical trial that will study the effectiveness of a medication currently approved for the treatment of pain and narcotic dependence. This medication is called buprenorphine, also known by its brand name, Suboxone.
All participants must be 18 years of age or older and be experiencing an episode of major depression. The symptoms of major depression include low mood, loss of interest and enjoyment, non-restorative sleep, change in appetite, low energy, poor concentration, feeling slowed down, and thoughts of death or suicide. During this episode of depression, all participants must have tried at least two other antidepressants that have been ineffective at treating the depression. Participants can continue to take currently prescribed antidepressant medications during the trial.
More than 50% of patients do not respond to treatment with an antidepressant, and another 20-30% do not respond to second or third-line trials of antidepressant medications or psychotherapy. According to Jordan F. Karp, MD, Associate Professor of Psychiatry and Anesthesiology at the University of Pittsburgh School of Medicine and the principal investigator of the study, “Chronic depression is a killer. Being chronically depressed is associated with shortened life span, heart disease, and brain atrophy. Patients and mental health practicitioners are desperate for new interventions to treat this devastating illness.”
The medication used in the trial, buprenorphine, is a narcotic analgesic, but has also been observed to have antidepressant effects. Karp says that the dose of buprenophine used in the study is a fraction of the dose used to treat pain or narcotic dependence.
Participants in the study, sponsored by the Brain and Behavior Research Foundation, will receive a thorough psychiatric and medical evaluation. They must agree to take the study medication – buprenorphine or placebo – for 8 weeks. Participants who received placebo during the first 8 weeks of the study will be offered open treatment with the buprenorphine for another 8 weeks.
The research team works closely with each participant’s primary care physician and/or referring psychiatrist and psychotherapist. Participants may continue to take currently prescribed antidepressant medications while in the trial, but must not take any narcotics like Vicodin, or Percocet while participating.
The study medication and other interventions including a brain MRI are provided at no cost.
According to Karp, “This study may transform how we understand and treat difficult to manage depression. We’ve got to continue to develop and test innovative treatments.”
For more information, please call (412) 246-6111.