Pramipexole to Enhance Social Connections
Eligible age
18–50 yrs
Accepts
All genders
Locations
2 states
Healthy volunteers
No
See if you qualify for this study
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About this study
This study seeks to understand if the medication pramipexole improves social connectedness and functioning in adults (ages 18-50) who experience anxiety or depression. The study plans to enroll 108 participants total across two sites (University of California San Diego and New York State Psychiatric Institute). Pramipexole will be given in a 6-week randomized, double-blind, placebo-controlled trial. Social reward processing will be assessed using measures of brain function (fMRI), behavior, and self-report at baseline and week 6. Knowledge gained from this study will help determine the therapeutic potential of targeting the dopamine system to remediate social disconnection as an anxiety and depression intervention.
Sponsor: University of California, San Diego
You may qualify if…
- ✓ 1. Clinically elevated levels of anxiety (OASIS ≥ 8) or depression or (PHQ-9 ≥ 10).
- ✓ 2. Moderate or greater social disability assessed with clinician-rating (SDS - Social ≥ 5).
- ✓ 3. Below the normative mean for temperamental reward sensitivity (ATQ - Approach \< 35).
- ✓ 4. Age 18-50.
- ✓ 5. Ability to provide written informed consent.
- ✓ 6. English proficiency.
You may not qualify if…
- ✕ 1. Current, imminent risk of suicide assessed with Clinical Interview and Columbia Suicide Severity Rating Scale (C-SSRS) "yes" response to items 4, 5 (past month), 6 (past 3 months), or suicide attempt in the past year.
- ✕ 2. History of bipolar or psychotic disorders.
- ✕ 3. History of major neurological disorder or moderate to severe traumatic brain injury.
- ✕ 4. History of severe or unstable medical conditions that might be compromised by participation in the study (e.g., cardiovascular, hepatic, renal, respiratory, endocrine, neurologic or hematologic disease; history of seizure disorder).
- ✕ 5. Past 6-month substance use disorder (any severity) with the exception of mild alcohol, cannabis, or tobacco use disorder, which will be permitted in the study.
- ✕ 6. History of impulse control problems (e.g., pathological gambling).
- ✕ 7. First-degree relative with a diagnosis of schizophrenia-spectrum or other psychotic disorder or bipolar disorder.
- ✕ 8. History of cocaine or stimulant use (e.g., amphetamine, cocaine, methamphetamine; except for physician prescribed stimulants) in the past 6 months.
Where it's recruiting
San Diego
New York
Source: ClinicalTrials.gov · NCT06269146 · last updated 2025-04-17