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Dopamine Agonist

Pramipexole for Anxiety and Depression

Phase 2
Recruiting
Led By Franklin Schneier, MD
Research Sponsored by University of California, San Diego
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 18-50
Clinically elevated levels of anxiety (OASIS ≥ 8) or depression (PHQ-9 ≥ 10)
Must not have
First-degree relative with a diagnosis of schizophrenia-spectrum or other psychotic disorder or bipolar disorder
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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 6

Summary

This trial tests if pramipexole can help adults with anxiety or depression feel more socially connected. Pramipexole increases dopamine levels in the brain, which may improve how people respond to positive social interactions. The study will measure brain activity, behavior, and self-reported feelings before and after a period of treatment. Pramipexole has shown potential to improve mood and reduce anxiety in both experimental and clinical settings.

Who is the study for?
This trial is for adults aged 18-50 who are struggling with depression, anxiety, or feeling socially isolated. Participants must be able to undergo brain scans (fMRI) and commit to a 6-week study period. The trial excludes individuals outside this age range or those unable to complete the required assessments.
What is being tested?
The trial is testing if pramipexole can help people feel more connected by improving social functioning. It's a double-blind study, meaning neither participants nor researchers know who gets the real pill or placebo. Assessments will be done at the start and after six weeks using fMRI scans and questionnaires.
What are the potential side effects?
Pramipexole may cause side effects like nausea, dizziness, unusual dreams, constipation, weakness, and potential behavioral changes such as increased gambling urges or other intense urges.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 50 years old.
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I have high levels of anxiety or depression.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a close family member with schizophrenia, bipolar disorder, or another psychotic disorder.
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I do not have severe health issues that could worsen by joining this study.
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I have a history of bipolar or psychotic disorders.
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I have had a serious brain disorder or a significant head injury.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 6
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 6 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Neural activation during social reward anticipation
Secondary study objectives
Future approach motivation
Motivation to engage in shared experiences with others
Neural activation during opportunities to disclose to others
+3 more
Other study objectives
Anxious behavior during the social affiliation task
Negative affect in response to the social affiliation task
Neural activation during social punishment anticipation
+1 more

Trial Design

3Treatment groups
Active Control
Placebo Group
Group I: Pramipexole 2.5 mg/dActive Control1 Intervention
Each participant will take pramipexole in identical capsular form twice daily for 6 weeks.
Group II: Pramipexole 1 mg/dActive Control1 Intervention
Each participant will take pramipexole in identical capsular form twice daily for 6 weeks.
Group III: PlaceboPlacebo Group1 Intervention
Each participant will take placebo in identical capsular form twice daily for 6 weeks.

Find a Location

Who is running the clinical trial?

University of California, San DiegoLead Sponsor
1,180 Previous Clinical Trials
1,574,948 Total Patients Enrolled
3 Trials studying Generalized Anxiety Disorder
135 Patients Enrolled for Generalized Anxiety Disorder
National Institute of Mental Health (NIMH)NIH
2,915 Previous Clinical Trials
2,738,647 Total Patients Enrolled
36 Trials studying Generalized Anxiety Disorder
8,692 Patients Enrolled for Generalized Anxiety Disorder
New York State Psychiatric InstituteOTHER
478 Previous Clinical Trials
153,865 Total Patients Enrolled
3 Trials studying Generalized Anxiety Disorder
42 Patients Enrolled for Generalized Anxiety Disorder
~36 spots leftby Mar 2025
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