Summary

Eligibility
for people ages 18-50 (full criteria)
Location
at San Diego, California and other locations
Dates
study started
completion around
Principal Investigator
by Charles Taylor, PhD

Description

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.

Official Title

Targeting Dopamine-Mediated Social Reward Sensitivity to Remediate Social Disconnection

Details

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.

Keywords

Anxiety Disorders, Anxiety, Depression, Social Disconnection, Pramipexole, Dexpramipexole, Pramipexole Pill, Pramipexole 1 mg/d, Pramipexole 2.5 mg/d

Eligibility

You can join if…

Open to people ages 18-50

  1. Clinically elevated levels of anxiety (OASIS ≥ 8) or depression or (PHQ-9 ≥ 10).
  2. Moderate or greater social disability assessed with self-rating (SDS - Social ≥ 5).
  3. Below the normative mean for temperamental reward sensitivity (ATQ - Approach < 32).
  4. Age 18-50.
  5. Ability to provide written informed consent.
  6. English proficiency.

You CAN'T join if...

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, or 6.
  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 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) in the past 6 months.
  9. History of dopaminergic drug use in the past 6 months.
  10. Positive urinalysis screen for psychoactive drug use (that is not physician prescribed).
  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.

Locations

  • University of California, San Diego accepting new patients
    San Diego California 92093 United States
  • New York State Psychiatric Institute not yet accepting patients
    New York New York 10032 United States

Lead Scientist at UCSD

  • Charles Taylor, PhD
    Associate Adjunct Professor, Psychiatry, Vc-health Sciences-schools. Authored (or co-authored) 67 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Diego
ID
NCT06269146
Phase
Phase 2 research study
Study Type
Interventional
Participants
Expecting 108 study participants
Last Updated