Brain Stimulation for Depression
(RAISE Trial)
Trial Summary
What is the purpose of this trial?
The central goal of this application is to demonstrate the causal contribution of reward learning signals (expected values and reward prediction errors \[RPE\]) to antidepressant responses (Aim1) by experimentally manipulating expected values using transcranial magnetic stimulation (TMS) targeting the vmPFC (Aim 2) and μ-opioid striatal RPE signal using pharmacological approaches (Aim 3).
Will I have to stop taking my current medications?
Yes, you will need to stop taking antidepressant medications at least 21 days before the imaging data collection (five weeks for fluoxetine). Additionally, you cannot be taking any psychiatric medications or other potential augmenting agents.
What data supports the effectiveness of the drug Buprenorphine for depression?
Research shows that low doses of Buprenorphine can effectively reduce depressive symptoms and serious suicidal thoughts, even in patients who don't respond to other antidepressants. However, more studies are needed to understand its long-term effects and the best way to use it with other treatments.12345
Is brain stimulation for depression safe for humans?
Buprenorphine, used in various forms for depression and opioid dependence, is generally considered safe and well-tolerated at low doses, though more studies are needed to understand long-term effects. It has been shown to reduce depressive symptoms and is effective in opioid dependence treatment, with some formulations designed to minimize misuse.13678
How does the treatment of brain stimulation with Buprenorphine and Naltrexone for depression differ from other treatments?
This treatment is unique because it combines brain stimulation, which directly targets brain areas involved in mood regulation, with Buprenorphine and Naltrexone, drugs typically used for addiction treatment, potentially offering a novel approach for treatment-resistant depression by addressing both mood and reward system dysfunctions.910111213
Research Team
Marta Peciña, MD, PhD
Principal Investigator
University of Pittsburgh
Eligibility Criteria
Adults aged 18-55 with major depression, who have tried at most one antidepressant without success, can join this trial. They must be fluent in English and off antidepressants for at least 21 days. People with a history of psychotic disorders, substance dependence (except nicotine), or those currently suicidal or on certain psychiatric medications cannot participate.Inclusion Criteria
Exclusion Criteria
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive TMS sessions and pharmacological interventions to modulate reward learning signals
Follow-up
Participants are monitored for changes in BOLD signal during the Antidepressant fMRI Task
Treatment Details
Interventions
- Buprenorphine (Opioid Partial Agonist)
- Naltrexone (Opioid Antagonist)
- Theta Burst Stimulation (Device)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Marta Peciña, MD PhD
Lead Sponsor