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Dopamine Agonist

Pramipexole 2.5 mg/d for Anxiety

Phase 2

Waitlist Available

Led By Charles Taylor, PhD

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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 6

Awards & highlights

Study Summary

This trial aims to see if the medication pramipexole can help adults aged 18-50 with anxiety or depression to improve their social connections and functioning. They will enroll 108 participants from

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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 6

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 6

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 6 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Neural activation during social reward anticipation

Secondary outcome measures

Blood plasma pramipexole concentrations

Future approach motivation

Motivation to engage in shared experiences with others

+4 more

Other outcome measures

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.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of California, San DiegoLead Sponsor

1,120 Previous Clinical Trials

1,521,299 Total Patients Enrolled

6 Trials studying Anxiety

1,846 Patients Enrolled for Anxiety

National Institute of Mental Health (NIMH)NIH

2,783 Previous Clinical Trials

2,689,041 Total Patients Enrolled

82 Trials studying Anxiety

38,992 Patients Enrolled for Anxiety

New York State Psychiatric InstituteOTHER

475 Previous Clinical Trials

153,799 Total Patients Enrolled

4 Trials studying Anxiety

162 Patients Enrolled for Anxiety

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who is eligible to participate in this clinical investigation?

"Individuals aged between 18 and 50 with a diagnosis of depression are eligible to participate in this study, which aims to recruit approximately 108 participants."

Answered by AI

Is the research study open to individuals who are below 40 years of age?

"For this trial's eligibility criteria, individuals must be at least 18 years old and no more than 50 years old to participate."

Answered by AI

Are there ongoing efforts to actively enroll participants in this trial?

"As per information available on clinicaltrials.gov, this particular research endeavor is not presently seeking subjects. The trial was initially listed on February 1st, 2024 and the most recent update occurred on February 13th, 2024. Despite its closure to enrollment, it's worth noting that currently there are a substantial number of other studies - precisely 1653 - actively in need of participants."

Answered by AI

What are the potential risks associated with daily administration of Pramipexole at a dosage of 1 milligram for patients?

"Based on the phase of this trial, our team at Power rates Pramipexole 1 mg/day with a safety score of 2. This signifies that while there is existing safety data, evidence for effectiveness is lacking in this Phase 2 study."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Pramipexole to Enhance Social Connections

Charles Taylor 2024. "Pramipexole to Enhance Social Connections". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06269146.

All > Anxiety Disorder