Pramipexole to Enhance Social Connections
Status: Not yet recruiting

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.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  Clinically elevated levels of anxiety (OASIS ≥ 8) or depression or (PHQ-9 ≥ 10). Moderate or greater social disability assessed with self-rating (SDS - Social ≥ 5). Below the normative mean for temperamental reward sensitivity (ATQ - Approach < 32). Age 18-50. Ability to provide written informed consent. 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:  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. 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 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) in the past 6 months. History of dopaminergic drug use in the past 6 months. Positive urinalysis screen for psychoactive drug use (that is not physician prescribed). 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. Anticipated inability to complete the study procedures as determined by study personnel. 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). Non-correctable vision or hearing problems, as some tests require intact sensory functioning. No telephone or easy access to telephone. MRI contraindications CGI-S score of 6 or 7. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 50 Years - StdAgeList: Adult