RecruitingPhase 2NCT06269146

Pramipexole to Enhance Social Connections

Targeting Dopamine-Mediated Social Reward Sensitivity to Remediate Social Disconnection

Sponsor

University of California, San Diego

Enrollment

108 participants

Start Date

May 13, 2024

Study Type

INTERVENTIONAL

Conditions

Depression Anxiety Anxiety Disorders Social Disconnection

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether pramipexole — a drug that acts on dopamine pathways in the brain and is used for Parkinson's disease — can help improve social connections and reduce anxiety or depression in people who are socially withdrawn and have low reward sensitivity (find it hard to feel motivated or rewarded by social interaction). **You may be eligible if...** - You are between 18 and 50 years old - You have elevated anxiety or depression (measured by standard scales) - You have significant social difficulties in daily life - You have below-average reward sensitivity (tendency to seek out and enjoy positive experiences) - You speak English and can provide informed consent **You may NOT be eligible if...** - You have bipolar disorder, a history of psychosis, or current serious suicidal thoughts - You have certain neurological or cardiovascular conditions - You are currently taking medications that interact with pramipexole Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPramipexole Pill

The study drug, pramipexole, is an FDA-approved medication for the treatment of Parkinson's and restless leg syndrome. Pramipexole (Mirapex) tablets are taken orally, with or without food.

DRUGPlacebo Pill

Placebo will match the study drug in mode of administration, color, size, and taste.