Dopamine drug pramipexole tested to ease social disconnection

NCT ID NCT06269146

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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.

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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

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