Targeting Dopamine-Mediated Social Reward Sensitivity to Remediate Social Disconnection

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 50
Healthy Volunteers: f
View:

• Clinically elevated levels of anxiety (OASIS ≥ 8) or depression or (PHQ-9 ≥ 10).

• Moderate or greater social disability assessed with self-rating (SDS - Social ≥ 5).

• Below the normative mean for temperamental reward sensitivity (ATQ - Approach \< 32).

• Age 18-50.

• Ability to provide written informed consent.

• English proficiency.

Locations
United States
California
University of California, San Diego
RECRUITING
San Diego
New York
New York State Psychiatric Institute
NOT_YET_RECRUITING
New York City
Contact Information
Primary
Nuzhat Beg, MBBS, MAS
nbeg@health.ucsd.edu
858-534-6436
Backup
Taylor Smith, B.S.
trs004@health.ucsd.edu
Time Frame
Start Date: 2024-05-13
Estimated Completion Date: 2026-03
Participants
Target number of participants: 108
Treatments
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.
Related Therapeutic Areas
Sponsors
Collaborators: New York State Psychiatric Institute, National Institute of Mental Health (NIMH)
Leads: University of California, San Diego

This content was sourced from clinicaltrials.gov