protocolSection identificationModule nctId: NCT06269146, orgStudyIdInfo id: 806035, secondaryIdInfos id: 1R61MH129380-01, type: NIH, link: https://reporter.nih.gov/quickSearch/1R61MH129380-01, briefTitle: Pramipexole to Enhance Social Connections, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02, primaryCompletionDateStruct date: 2025-03, completionDateStruct date: 2025-03, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-02-21, sponsorCollaboratorsModule leadSponsor name: University of California, San Diego, class: OTHER, collaborators name: National Institute of Mental Health (NIMH), collaborators name: New York State Psychiatric Institute, descriptionModule briefSummary: 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., conditionsModule conditions: Anxiety Disorders, conditions: Anxiety, conditions: Depression, conditions: Social Disconnection, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, maskingDescription: The pharmacy will blind drug and placebo through identical encapsulation. Placebo will match the study drug in mode of administration, color, size, and taste., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 108, type: ESTIMATED, armsInterventionsModule interventions name: Pramipexole Pill, interventions name: Placebo Pill, outcomesModule primaryOutcomes measure: Neural activation during social reward anticipation, secondaryOutcomes measure: Neural activation during opportunities to disclose to others, secondaryOutcomes measure: Motivation to engage in shared experiences with others, secondaryOutcomes measure: Positive affect in response to the social affiliation task, secondaryOutcomes measure: Social approach goals during the social affiliation task, secondaryOutcomes measure: Social approach behavior during the social affiliation task, secondaryOutcomes measure: Future approach motivation, secondaryOutcomes measure: Blood plasma pramipexole concentrations, otherOutcomes measure: Negative affect in response to the social affiliation task, otherOutcomes measure: Neural activation during social punishment anticipation, otherOutcomes measure: Social avoidance goals during the social affiliation task, otherOutcomes measure: Anxious behavior during the social affiliation task, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: University of California, San Diego, city: San Diego, state: California, zip: 92093, country: United States, contacts name: Margaret K Satchwell, BS, role: CONTACT, phone: 858-822-4357, email: mksatchwell@health.ucsd.edu, geoPoint lat: 32.71533, lon: -117.15726, locations facility: New York State Psychiatric Institute, city: New York, state: New York, zip: 10032, country: United States, contacts name: Liza Handler, BS, role: CONTACT, phone: 917-652-6355, email: liza.handler@nyspi.columbia.edu, geoPoint lat: 40.71427, lon: -74.00597, hasResults: False