Pramipexole to Enhance Social Connections

NCT ID: NCT06269146

Last Updated: 2025-04-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 108 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-13
• Study Completion Date: 2026-03-31

Brief 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.

Detailed Description

This study seeks to understand how modulating functioning of the neurotransmitter dopamine affects brain circuits, behaviors, and subjective experiences that are believed to underlie an individual's motivation to establish and maintain positive social connections. This knowledge will help advance understanding of brain mechanisms that can be used to better treat social functioning impairments in people experiencing anxiety or depression. The R61 phase project will evaluate the effects of pramipexole (a medication that increases dopamine signaling in the brain) on responses to different types of positive social cues or contexts. The study drug will be given in a 6-week randomized, double-blind, placebo-controlled trial for individuals with clinical levels of anxiety or depression.

Aim 1 will test the hypothesis that pramipexole increases the anticipation of social rewards compared to placebo. Aim 2 will determine which dose of pramipexole (1.0 or 2.5 mg/d) produces a greater effect on social reward anticipation. To achieve these aims, approximately 108 participants (ages 18-50) with clinically elevated anxiety or depression will be randomized across two sites and randomized in equal proportions to one of two doses of pramipexole (1.0 mg/d or 2.5 mg/d) or placebo. They will complete standardized paradigms assessing social reward processing 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.

Conditions

Anxiety Disorders; Anxiety; Depression; Social Disconnection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Pramipexole 1 mg/d

Each participant will take pramipexole in identical capsular form twice daily for 6 weeks.

Group Type: ACTIVE_COMPARATOR

Pramipexole Pill

Intervention Type: DRUG

The study drug, pramipexole, is an FDA-approved medication for the treatment of Parkinson's and restless leg syndrome. Pramipexole (Mirapex) tablets are taken orally, with or without food.

Pramipexole 2.5 mg/d

Each participant will take pramipexole in identical capsular form twice daily for 6 weeks.

Group Type: ACTIVE_COMPARATOR

Pramipexole Pill

Intervention Type: DRUG

The study drug, pramipexole, is an FDA-approved medication for the treatment of Parkinson's and restless leg syndrome. Pramipexole (Mirapex) tablets are taken orally, with or without food.

Placebo

Each participant will take placebo in identical capsular form twice daily for 6 weeks.

Group Type: PLACEBO_COMPARATOR

Placebo Pill

Intervention Type: DRUG

Placebo will match the study drug in mode of administration, color, size, and taste.

Interventions

Pramipexole Pill

The study drug, pramipexole, is an FDA-approved medication for the treatment of Parkinson's and restless leg syndrome. Pramipexole (Mirapex) tablets are taken orally, with or without food.

Intervention Type: DRUG

Placebo Pill

Placebo will match the study drug in mode of administration, color, size, and taste.

Intervention Type: DRUG

Other Intervention Names

Mirapex

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

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

New York State Psychiatric Institute

OTHER

Sponsor Role: collaborator

University of California, San Diego

OTHER

Sponsor Role: lead

Responsible Party

Charles Taylor

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Charles Taylor, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Diego

Franklin Schneier, MD

Role: PRINCIPAL_INVESTIGATOR

New York State Psychiatric Institute

Locations

University of California, San Diego

San Diego, California, United States

Site Status: RECRUITING

New York State Psychiatric Institute

New York, New York, United States

Site Status: NOT_YET_RECRUITING

Countries

United States

Central Contacts

Nuzhat Beg, MBBS, MAS

Role: CONTACT

nbeg@health.ucsd.edu

858-534-6436

Taylor Smith, B.S.

Role: CONTACT

trs004@health.ucsd.edu

Facility Contacts

Nuzhat Beg

Role: primary

nbeg@health.ucsd.edu

Isaac Dietz-Green, BA

Role: primary

isaac.deitzgreen@nyspi.columbia.edu

6464701288

Other Identifiers

1R61MH129380-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

806035

Identifier Type: -

Identifier Source: org_study_id