Dopamine drug pramipexole tested to ease social disconnection
NCT ID NCT06269146
First seen Sep 23, 2026 · Last updated Sep 24, 2026 · Updated 1 time
Summary
Researchers are testing whether pramipexole, a drug approved for Parkinson's disease, can improve social connectedness in adults with anxiety or depression. The trial enrolls 108 people aged 18 to 50 who have moderate social disability and low reward sensitivity. For six weeks, participants receive either pramipexole or a placebo, and researchers measure brain activity, behavior, and self-reported social feelings. The goal is to learn if targeting the dopamine system can help treat social disconnection.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- pramipexole, an FDA-approved drug for Parkinson's disease and restless leg syndrome
- What this could lead to
- If pramipexole helps, it could offer a new way to treat social disconnection in people with anxiety or depression.
- What could go wrong
- Pramipexole can cause side effects like nausea, dizziness, or sleepiness, and this early-phase trial may not show a clear benefit for social connection.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
About 108 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
May 2024
- Expected to finish
-
Mar 2027
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 50 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Anxiety are added.
By submitting, you agree to our Terms of use
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
New York State Psychiatric Institute
New York, New York, 10032, United States
-
University of California, San Diego
San Diego, California, 92093, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Smartphone cartoons put to the test against Kids' Cast-Removal fears
- Workplace loneliness and anxiety under the microscope at hamburg university
- Can a pop-it toy make a Child's blood draw hurt less?
- Can writing about discrimination heal LGBTQ+ mental health?
- Can a 20-Minute massage calm women before breast surgery?
- Which works best for autism anxiety: drug, therapy, or neither?