Stratified Pharmacological Approaches for Regulating Circuit-Level Effects

Part of paid clinical trials in Palo Alto, California.

Sponsor
Stanford University
Study ID
NCT07022405
Phase
PHASE2
Status
Recruiting
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Conditions

  • Depression - Major Depressive Disorder

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Pramipexole Immediate Release — DRUG
    The intervention involves taking pramipexole immediate release (IR) for 8 weeks followed by 2 weeks of down titration and follow up.

Study Details

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.

Key Dates

Start date
Jan 23, 2026
Status verified
May 2026
Primary completion
Aug 31, 2030
Completion
Aug 31, 2030

Study Design

Enrollment
60 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Pramipexole Treatment Arm
    The investigators will ask eligible participants to attend up to 2 in-person testing visits and commit to 10 weeks of treatment and remote participation. The in-person testing visit at the beginning of the study lasts up to 4 hours. During this visit participants will undergo a non-invasive functional magnetic resonance imaging (fMRI) brain scan, complete game-like tasks in the scanner, and answer questions regarding emotional health. Treatment involves an 8-week course of pramipexole and followed by a 2-week down titration and follow up. During this 10-week period, participants will meet remotely with a study coordinator or study clinician each week to answer questions about medication side effects and emotional health and to complete online surveys to monitor mood.

Primary Outcome Measure

QIDS-SR: Quick Inventory of Depressive Symptomatology Self-Report [ Time Frame: 8 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Stanford UniversityPalo AltoCalifornia94305
Isabelle Wydler
[email protected]
650-736-4393
Daniella Evangelista
[email protected]
Leanne Williams, Ph.D. (PRINCIPAL_INVESTIGATOR)
Teddy Akiki, MD (PRINCIPAL_INVESTIGATOR)

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