Pramipexole to Enhance Social Connections

NCT06269146 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: 8060351R61MH129380-01
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 2

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.

Conditions

Anxiety Disorders; Anxiety; Depression; Social Disconnection

Keywords

Pramipexole; Anxiety; Depression

Outcome Measures

Primary Outcomes (1)

• Neural activation during social reward anticipation

  The primary outcome of interest is blood oxygen level dependent (BOLD) response during anticipation of positive valence social cues vs. baseline in the striatum region of interest (ROI) mask, defined according to a meta-analysis of the social incentive delay task.

  Baseline, week 6

Secondary Outcomes (7)

• Neural activation during opportunities to disclose to others

  Baseline, week 6

• Motivation to engage in shared experiences with others

  Baseline, week 6

• Positive affect in response to the social affiliation task

  Baseline, week 6

• Social approach goals during the social affiliation task

  Baseline, week 6

• Social approach behavior during the social affiliation task

  Baseline, week 6

Other Outcomes (4)

• Negative affect in response to the social affiliation task

  Baseline, week 6

• Neural activation during social punishment anticipation

  Baseline, week 6

• Social avoidance goals during the social affiliation task

  Baseline, week 6

Study Arms (3)

Pramipexole 1 mg/d

ACTIVE COMPARATOR

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

Drug: Pramipexole Pill

Pramipexole 2.5 mg/d

ACTIVE COMPARATOR

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

Drug: Pramipexole Pill

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo Pill

Interventions

Pramipexole Pill 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.

Also known as: Mirapex

Pramipexole 1 mg/d; Pramipexole 2.5 mg/d

Placebo Pill DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.
• History of bipolar or psychotic disorders.
• History of major neurological disorder or moderate to severe traumatic brain injury.
• 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).
• 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.
• History of impulse control problems (e.g., pathological gambling).
• First-degree relative with a diagnosis of schizophrenia-spectrum or other psychotic disorder or bipolar disorder.
• History of cocaine or stimulant use (e.g., amphetamine, cocaine, methamphetamine; except for physician prescribed stimulants) in the past 6 months.
• History of dopaminergic agonists drug use (e.g., pramipexole, ropinirole, apomorphine, rotigotine) in the past 6 months.
• Positive urinalysis screen for psychoactive drug use (that is not physician prescribed or THC).
• Abnormal and clinically relevant blood count, liver, renal or EKG findings as determined by physician.
• 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.
• Concurrent empirically supported psychosocial treatments for anxiety or mood disorders (e.g., cognitive behavioral therapy).
• 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
• Anticipated inability to attend regular study appointments.

Sponsors & Collaborators

• University of California, San Diego: lead
• National Institute of Mental Health (NIMH): collaborator
• New York State Psychiatric Institute: collaborator

Study Sites (2)

University of California, San Diego

San Diego, California, 92093, United States

RECRUITING

New York State Psychiatric Institute

New York, New York, 10032, United States

NOT YET RECRUITING

MeSH Terms

Conditions

Anxiety Disorders; Depression

Interventions

Pramipexole

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Benzothiazoles; Thiazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Charles Taylor, PhD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

• Franklin Schneier, MD

  New York State Psychiatric Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nuzhat Beg, MBBS, MAS

CONTACT

858-534-6436; nbeg@health.ucsd.edu

Taylor Smith, B.S.

CONTACT

trs004@health.ucsd.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The pharmacy will blind drug and placebo through identical encapsulation. Placebo will match the study drug in mode of administration, color, size, and taste.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 13, 2024
• First Posted: February 21, 2024
• Study Start: May 13, 2024
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: April 17, 2025

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Time Frame: Every 6 months following the NDA submission schedule.
• Access Criteria: Eligible researches can submit a Data Access Request to the NDA to obtain access to de-identified study data for research purposes.

Locations

US (2)