Actively Recruiting
Pramipexole to Enhance Social Connections
Led by University of California, San Diego · Updated on 2025-04-17
108
Participants Needed
2
Research Sites
93 weeks
Total Duration
On this page
Sponsors
U
University of California, San Diego
Lead Sponsor
N
National Institute of Mental Health (NIMH)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Pramipexole to Enhance Social Connections
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Clinically elevated levels of anxiety (OASIS 2 8) or depression (PHQ-9 2 10)
- Moderate or greater social disability assessed by clinician (SDS - Social 2 5)
- Below the normal range for temperamental reward sensitivity (ATQ - Approach < 35)
- Age between 18 and 50 years
- Ability to provide written informed consent
- Proficient in English
You will not qualify if you...
- Current or recent risk of suicide based on clinical interview and Columbia Suicide Severity Rating Scale
- History of bipolar or psychotic disorders
- History of major neurological disorder or moderate to severe traumatic brain injury
- Severe or unstable medical conditions that could be worsened by the study
- Substance use disorder in past 6 months except mild alcohol, cannabis, or tobacco use
- History of impulse control problems such as pathological gambling
- First-degree relative with schizophrenia-spectrum, psychotic disorder, or bipolar disorder
- Use of cocaine or stimulants (except prescribed) in past 6 months
- Use of dopaminergic agonist drugs in past 6 months
- Positive drug screen for non-prescribed psychoactive substances
- Abnormal blood count, liver, kidney, or EKG tests
- Women who are pregnant, breastfeeding, or planning pregnancy within 6 months
- Must use contraception if of childbearing potential
- Receiving cognitive behavioral therapy or other psychosocial treatments for anxiety or mood disorders
- Use of psychotropic medications within 14 days before study (except fluoxetine within 30 days)
- Unable to attend regular study visits or complete study procedures
- Clinical conditions requiring more urgent care
- Non-correctable vision or hearing problems
- No telephone access
- MRI contraindications
- Clinical Global Impression-Severity score of 6 or 7
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
University of California, San Diego
San Diego, California, United States, 92093
Actively Recruiting
2
New York State Psychiatric Institute
New York, New York, United States, 10032
Not Yet Recruiting
Research Team
N
Nuzhat Beg, MBBS, MAS
CONTACT
T
Taylor Smith, B.S.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here