Using pramipexole to improve social connections in adults with anxiety or depression

Targeting Dopamine-Mediated Social Reward Sensitivity to Remediate Social Disconnection

This study is testing if the medication pramipexole can help adults aged 18-50 with anxiety or depression feel more connected to others and improve their social interactions.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 108 (estimated)
• Ages: 18 Years to 50 Years
• Sex: All
• Sponsor: University of California, San Diego (Academic / other)
• Locations: 2 sites (San Diego, California and 1 other locations)
• Trial ID: NCT06269146 on ClinicalTrials.gov

What this trial studies

This study investigates whether the medication pramipexole can enhance social connectedness and functioning in adults aged 18-50 who experience anxiety or depression. It involves a 6-week randomized, double-blind, placebo-controlled trial with 108 participants across two sites. The study will assess social reward processing through brain function measures (fMRI), behavioral assessments, and self-reports at baseline and after six weeks. The goal is to understand how dopamine modulation can improve social interactions in individuals facing these mental health challenges.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-50 with clinically elevated levels of anxiety or depression and moderate social disability.

Not a fit: Patients with a history of bipolar or psychotic disorders, severe neurological conditions, or those at imminent risk of suicide may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new therapeutic approach to improve social functioning in patients with anxiety and depression.

How similar studies have performed: Other studies targeting dopamine modulation for social functioning have shown promise, suggesting potential success for this approach.

Eligibility criteria

Inclusion Criteria:

1. Clinically elevated levels of anxiety (OASIS ≥ 8) or depression or (PHQ-9 ≥ 10).
2. Moderate or greater social disability assessed with clinician-rating (SDS - Social ≥ 5).
3. Below the normative mean for temperamental reward sensitivity (ATQ - Approach \< 35).
4. Age 18-50.
5. Ability to provide written informed consent.
6. English proficiency.

Exclusion Criteria:

Exclusion criteria are included to ensure that participation does not place subjects at undue risk, and to minimize confounding interpretation of our findings:

1. 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.
2. History of bipolar or psychotic disorders.
3. History of major neurological disorder or moderate to severe traumatic brain injury.
4. 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).
5. Past 6-month substance use disorder (any severity) with the exception of mild alcohol, cannabis, or tobacco use disorder, which will be permitted in the study.
6. History of impulse control problems (e.g., pathological gambling).
7. First-degree relative with a diagnosis of schizophrenia-spectrum or other psychotic disorder or bipolar disorder.
8. History of cocaine or stimulant use (e.g., amphetamine, cocaine, methamphetamine; except for physician prescribed stimulants) in the past 6 months.
9. History of dopaminergic agonists drug use (e.g., pramipexole, ropinirole, apomorphine, rotigotine) in the past 6 months.
10. Positive urinalysis screen for psychoactive drug use (that is not physician prescribed or THC).
11. Abnormal and clinically relevant blood count, liver, renal or EKG findings as determined by physician.
12. Women who are pregnant, breastfeeding, or planning to become pregnant within the next 6 months. Individuals of childbearing potential must agree to use an acceptable method of contraception from at least 21 days prior to the first dose of study drug and for 3 months after the last dose of study drug for study entry.
13. Concurrent empirically supported psychosocial treatments for anxiety or mood disorders (e.g., cognitive behavioral therapy).
14. Use of any psychotropic medication (e.g. SSRIs, benzodiazepines) within 14 days before study entry \[except for fluoxetine within 30 days\]. Concurrent use is prohibited during the study
15. Anticipated inability to attend regular study appointments.
16. Anticipated inability to complete the study procedures as determined by study personnel.
17. Clinical conditions assessed by the interviewer that necessitate more imminent clinical care. These criteria are in place so participants with these other, more severe symptoms can be referred for appropriate services (e.g. self-injurious behavior or exposure to a severe traumatic event in the past week).
18. Non-correctable vision or hearing problems, as some tests require intact sensory functioning.
19. No telephone or easy access to telephone.
20. MRI contraindications
21. CGI-S score of 6 or 7.

Where this trial is running

San Diego, California and 1 other locations

• University of California, San Diego — San Diego, California, United States (Recruiting)
• New York State Psychiatric Institute — New York, New York, United States (Not_yet_recruiting)

Study contacts

• Principal investigator: Charles Taylor, PhD — University of California, San Diego
• Study coordinator: Nuzhat Beg, MBBS, MAS

Conditions Anxiety Disorders; Anxiety; Depression; Social Disconnection; Pramipexole