RECRUITING

Pramipexole to Enhance Social Connections

Conditions

Anxiety Disorders Anxiety Depression Social Disconnection Pramipexole

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Quick Facts

Study Start:2024-05-13

Study Completion:2025-03

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06269146

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 50 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT

Inclusion Criteria	Exclusion Criteria
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.	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) 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.

Inclusion Criteria

Exclusion Criteria

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.

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) 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.

Contacts and Locations

Study Contact

Nuzhat Beg, MBBS, MAS

CONTACT

858-534-6436

nbeg@health.ucsd.edu

Taylor Smith, B.S.

CONTACT

trs004@health.ucsd.edu

Principal Investigator

Charles Taylor, PhD

PRINCIPAL_INVESTIGATOR

University of California, San Diego

Franklin Schneier, MD

PRINCIPAL_INVESTIGATOR

New York State Psychiatric Institute

Study Locations (Sites)

University of California, San Diego

San Diego, California, 92093

United States

New York State Psychiatric Institute

New York, New York, 10032

United States

Collaborators and Investigators

Sponsor: University of California, San Diego

Charles Taylor, PhD, PRINCIPAL_INVESTIGATOR, University of California, San Diego
Franklin Schneier, MD, PRINCIPAL_INVESTIGATOR, New York State Psychiatric Institute

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-05-13

Study Completion Date2025-03

Study Record Updates

Study Start Date2024-05-13

Study Completion Date2025-03

Terms related to this study

Keywords Provided by Researchers

Pramipexole
Anxiety
Depression

Additional Relevant MeSH Terms

Anxiety Disorders
Anxiety
Depression
Social Disconnection