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Pramipexole to Enhance Social Connections

StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 7 months later Mar 2026 → Nov 2026
See other at-risk trials from University of California, San Diego

Record History

  1. Primary completion pushed from Mar 2026 to Nov 2026 Trial status changed: Unknown → Active, Not Recruiting · Completion pushed from Mar 2026 to Mar 2027 · Eligibility criteria expanded, about 27 words · 2 more Show 5 more changesShow less
    • Trial status changed: Unknown → Active, Not Recruiting
    • Completion pushed from Mar 2026 to Mar 2027
    • Eligibility criteria expanded, about 27 words
    • Secondary endpoints: details revised at 5 of 7 entries
    • Site details revised at 2 of 2 sites
  2. Changed Registry marked status Unknown; last known: Recruiting
  3. Trial status: Recruiting to Unknown Eligibility criteria expanded, about 13 wordsv6 Show 1 more changeShow less
    • Eligibility criteria expanded, about 13 words

    See this version in full on ClinicalTrials.gov ↗

  4. Primary and study completion dates: Mar 2025 to Mar 2026 Site contacts updated at 1 of 2 sitesv5 Show 1 more changeShow less
    • Site contacts updated at 1 of 2 sites
  5. Eligibility criteria expanded, about 11 words Site contacts updated at 1 of 2 sitesv4 Show 1 more changeShow less
    • Site contacts updated at 1 of 2 sites

    See this version in full on ClinicalTrials.gov ↗

Show 2 earlier versionsHide 2 earlier versions
  1. Site contacts updated at 1 of 2 sites Eligibility criteria expanded, about 1 wordv3 Show 1 more changeShow less
    • Eligibility criteria expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  2. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Feb 2024 to May 13, 2024 · Site details revised at 2 of 2 sitesv2 Show 2 more changesShow less
    • Start date changed from estimate of Feb 2024 to May 13, 2024
    • Site details revised at 2 of 2 sites
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06269146
Lead Sponsor University of California, San Diego
Collaborators: National Institute of Mental Health (NIMH), New York State Psychiatric Institute
Conditions Anxiety Disorders, Anxiety, Depression, Social Disconnection
Enrollment 108 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov