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

Depression Clinical Trial

Official title:

Neural Dimensions of Threat Reactivity and Regulation for Understanding Anxiety

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02220309
• Other study ID #: 27937
• Status: Enrolling by invitation
• Start date: August 2013
• Est. completion date: April 2025

Study information

• Verified date: April 2024
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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).

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

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 160
• Est. completion date: April 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Depression
• Depressive Disorder

Intervention

Drug:
• Pramipexole Oral Tablet
Pramipexole is an oral Dopamine agonist.

Locations

Country	Name	City	State
United States	Gronowski Center-5150 El Camino Real	Los Altos	California
United States	VAPAHCS/Palo Alto MIRECC-3801 Miranda Avenue	Palo Alto	California
United States	Stanford University Department of Psychiatry	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessments of symptoms and daily functioning	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
Primary	Brain imaging	Non-invasive MRI brain scan to see function and structure of brain.	12 weeks
Primary	Cognitive assessment	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

External Links

•   Research on Anxiety and Depression: The RAD Project
•   Research on Anxiety and Depression: The RAD Project