Stratified Pharmacological Approaches for Regulating Circuit-Level Effects
NCT07022405 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60
Last updated 2026-05-15
Summary
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.
Conditions
- Depression - Major Depressive Disorder
Interventions
- DRUG
-
Pramipexole Immediate Release
The intervention involves taking pramipexole immediate release (IR) for 8 weeks followed by 2 weeks of down titration and follow up.
Sponsors & Collaborators
-
National Institute of Mental Health (NIMH)
collaborator NIH - lead OTHER
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-01-23
- Primary Completion
- 2030-08-31
- Completion
- 2030-08-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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