Stanford RAD-AT Study (Research on Anxiety and Depression - Anhedonia Treatment)

April 15, 2024 updated by: Leanne Williams, Stanford University

Neural Dimensions of Threat Reactivity and Regulation for Understanding Anxiety

This research study is aimed at understanding behaviors and brain circuits that relate to anxiety and depression. Our goal is to learn which circuits of the brain are involved in anxiety and how these circuits might affect daily functioning.

This study has recently added an additional treatment component: participants undergo a 12 week course of either Pramipexole medication or rTMS therapy (explained below). The ultimate goal of the study is to offer participants experiencing anxiety and depression a treatment that is alternative to ones that have failed them in the past, and to apply the knowledge we gain from investigating the brain circuits involved in anxiety and depression to help personalize treatments.

We invite anyone who has recently experienced any symptoms of anxiety and/or depression to participate (no diagnosis is required to participate).

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

If you are eligible and choose to participate, we'll ask you to come in for 2 separate testing visits and 8 weeks of treatment in between.

In both the pre-treatment and post-treatment testing visit, you would complete game-like tasks on the computer, undergo a non-invasive MRI brain scan, and answer some questions about your emotional health. The entire visit takes place during 1-2 days at Stanford and lasts about 4-5 hours. We'll also ask you to complete a follow-up 12 weeks later, from home, during which we'll again ask you some questions on your emotional health.

The 8-week treatment phase will consist of your choice of either TMS (transcranial magnetic stimulation) or Pramipexole (a medication for depression). You will meet with study coordinators and MDs each week (Pramipexole) or each day (TMS) to receive treatment. You will also be asked to complete weekly online surveys to monitor your mood during the 2-month course of treatment.

To inquire more about participation, you can either sign up online or contact us.

Sign up online: http://med.stanford.edu/williamslab/research/current/rad.html Contact us: Call or text (650) 600-1609 or email rad-at-study@stanford.edu

Study Type

Observational

Enrollment (Estimated)

160

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Altos, California, United States, 94022
        • Gronowski Center-5150 El Camino Real
      • Palo Alto, California, United States, 94304
        • VAPAHCS/Palo Alto MIRECC-3801 Miranda Avenue
      • Stanford, California, United States, 94305
        • Stanford University Department of Psychiatry

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.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

We expect to enroll 160 individuals spanning the spectrum of anxiety and associated mood symptoms. These individuals include patients of the Gronowski Center, a community clinical psychology center in Palo Alto. We will also recruit from the community through various advertisements. Further, participants will include healthy people recruited by advertisement.

Description

Inclusion Criteria:

  • Recent experiences of anxiety and/or depression
  • Ages 18-65

Exclusion Criteria:

  • Specific psychiatric medications (case-by-case basis)
  • A diagnosis of Bipolar 1 Disorder, Schizophrenia, or Obsessive Compulsive Disorder
  • Any of the following medical conditions: Parkinson's disease; liver or kidney disease; history of epilepsy or seizures; history of cardiovascular disorders (specifically orthostatic hypotension)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Anxiety and mood disorders
Drug: Pramipexole Oral Tablet
Pramipexole is an oral Dopamine agonist.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessments of symptoms and daily functioning
Time Frame: 12 weeks
General demographics questionnaires, alcohol use questionnaire, substance use questionnaires, Mood and Anxiety Symptom Questionnaire, Penn State Worry Questionnaire, Health at Work Performance Questionnaire, WHO Quality of Life questionnaire, Satisfaction with Life Survey, Emotion Regulation Questionnaire, Brief COPE questionnaire, Early Life Stress questionnaire, Quick Inventory of Depressive Symptomatology, Beck Depression Inventory, PTSD Checklist - Civilian Version, Beck Anxiety Inventory, Barratt Impulsiveness Scale, MINI Neuropsychiatric Interview
12 weeks
Brain imaging
Time Frame: 12 weeks
Non-invasive MRI brain scan to see function and structure of brain.
12 weeks
Cognitive assessment
Time Frame: 12 weeks
WebNeuro is an objective assessment of cognitive strengths and weaknesses. It provides an accurate and objective assessment of person's cognitive function and efficiency.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Investigators

  • Principal Investigator: Leanne M Williams, PhD, Stanford University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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 Major Dates

Study Start

August 1, 2013

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

April 1, 2025

Study Registration Dates

First Submitted

August 13, 2014

First Submitted That Met QC Criteria

August 16, 2014

First Posted (Estimated)

August 19, 2014

Study Record Updates

Last Update Posted (Actual)

April 16, 2024

Last Update Submitted That Met QC Criteria

April 15, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 27937

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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