BridgeMD
New treatment option for Anxiety Disorders
Official title Pramipexole to Enhance Social Connections
ClinicalTrials.gov ID: NCT06269146
What this study is testing
What is Pramipexole Pill?
Pramipexole Pill is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for anxiety disorders.
Also referred to as Mirapex.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 50
You may be able to join 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.
You likely can't join if
- Exclusion criteria are included to ensure that participation does not place people at undue risk, and to minimize confounding interpretation of our...
- Current, imminent risk of suicide assessed with Clinical Interview and Columbia Suicide Severity Rating Scale (C-SSRS) "yes" response to items 4, 5...
- 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...
- Past 6-month substance use disorder (any severity) with the exception of mild alcohol, cannabis, or tobacco use disorder, which will be permitted in...
See the full eligibility criteria
- 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.
- Exclusion criteria are included to ensure that participation does not place people 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 (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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- San Diego, California, United States
- New York, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 50 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include San Diego, California, United States; New York, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.