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 group

Locations

1
Stanford University94305, Palo AltoCalifornia, United States

Sponsors and collaborators

Stanford University

Lead sponsor

National Institute of Mental Health (NIMH)

Collaborator