Pramipexole to Enhance Social Connections
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-50
SponsorUniversity of California, San Diego
About this trial
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 criteria
Qualifiers
Clinically elevated levels of anxiety (OASIS ≥ 8) or depression or (PHQ-9 ≥ 10).
Moderate or greater social disability assessed with clinician-rating (SDS - Social ≥ 5).
Below the normative mean for temperamental reward sensitivity (ATQ - Approach < 35).
Age 18-50.
Disqualifiers
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.
History of bipolar or psychotic disorders.
History of major neurological disorder or moderate to severe traumatic brain injury.
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).
Trial design
Treatments tested in this trial
- Pramipexole Pill
- Placebo Pill
Treatment groups
108 Participants
are divided into 3 treatment groupsSponsors and collaborators
University of California, San Diego
Lead sponsor
National Institute of Mental Health (NIMH)
Collaborator
New York State Psychiatric Institute
Collaborator
Source ClinicalTrials.gov