Stratified Pharmacological Approaches for Regulating Circuit-Level Effects
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorStanford University
About this trial
This research study aims to understand how people with depression respond to the medication pramipexole and to determine whether clinical response differs depending on the function of specific circuits in the brain. The investigators hope to learn which circuits are involved in depression and how these circuits interact with pramipexole to affect mood, behavior, and cognition.
Eligible participants will undergo an 8-week treatment course of pramipexole followed by a 2-week down taper and follow up. The ultimate goal is to offer people experiencing depression a medication that is alternative to ones that may not have worked in the past and to apply the knowledge the investigators gain from investigating the brain circuits involved in depression to help personalize treatment.
The investigators invite anyone who has recently experienced symptoms of depression to participate. A prior diagnosis of depression is not required.
Eligibility criteria
Qualifiers
18-65 years old (inclusive)
Fluent and literate in English, with non-impaired intellectual abilities to ensure adequate comprehension of the task instructions.
Willing to provide written, informed consent.
Functional magnetic resonance imaging (fMRI) scanning eligibility. All participants will need to successfully complete the screening forms at the Stanford Center for Cognitive and Neurobiological Imaging (CNI).
Disqualifiers
Suicidality with active plan or as determined clinician judgment
Current or lifetime history of medical illness or brain injury that may interfere with assessments as determined by clinician judgment
Severe impediment to vision, hearing, and/or hand movement likely to interfere with ability to complete the assessments, or is unable and/or unlikely to follow the study protocols as determined by clinician judgment
Pregnant, breastfeeding or unwilling or unable to use adequate birth control throughout the study
Trial design
Treatments tested in this trial
- Pramipexole Immediate Release
Treatment groups
60 Participants
are divided into 1 treatment groupSponsors and collaborators
Stanford University
Lead sponsor
National Institute of Mental Health (NIMH)
Collaborator
Source ClinicalTrials.gov