Pramipexole to Enhance Social Connections

Part of paid clinical trials in San Diego, California.

Sponsor
University of California, San Diego
Study ID
NCT06269146
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Anxiety
  • Anxiety Disorders
  • Depression
  • Social Disconnection

Eligibility Criteria

Sex
ALL
Age
18 Years - 50 Years
Healthy Volunteers
Not accepted

Interventions

  • Pramipexole Pill — DRUG
    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.
  • Placebo Pill — DRUG
    Placebo will match the study drug in mode of administration, color, size, and taste.

Study Details

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.

Key Dates

Start date
May 13, 2024
Status verified
Aug 2024
Primary completion
Mar 31, 2026
Completion
Mar 31, 2026

Study Design

Enrollment
108 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Pramipexole 1 mg/d
    Each participant will take pramipexole in identical capsular form twice daily for 6 weeks.
  • Active Comparator: Pramipexole 2.5 mg/d
    Each participant will take pramipexole in identical capsular form twice daily for 6 weeks.
  • Placebo Comparator: Placebo
    Each participant will take placebo in identical capsular form twice daily for 6 weeks.

Primary Outcome Measure

Neural activation during social reward anticipation [ Time Frame: Baseline, week 6 ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
University of California, San DiegoSan DiegoCalifornia92093
New York State Psychiatric InstituteNew YorkNew York10032
Isaac Dietz-Green, BA
[email protected]
6464701288

Find similar trials in San Diego, CA

By condition
Depression
By specialty
PsychiatryMental healthBehavioral health
By research site
University of California, San Diego· San Diego, CANew York State Psychiatric Institute· New York, NY

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