NCT02220309

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
167

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2013

Longer than P75 for all trials

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 11, 2013

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

August 13, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 19, 2014

Completed
10.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 18, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 2, 2025

Completed
Last Updated

January 5, 2026

Status Verified

December 1, 2025

Enrollment Period

11.4 years

First QC Date

August 13, 2014

Last Update Submit

December 30, 2025

Conditions

Keywords

AnxietyDepressionSocial Anxiety DisorderBipolar disorder IIPTSDGADPhobia

Outcome Measures

Primary Outcomes (3)

  • 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

  • Brain imaging

    Non-invasive MRI brain scan to see function and structure of brain.

    12 weeks

  • 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

Study Arms (1)

Anxiety and mood disorders

Drug: Pramipexole Oral Tablet

Interventions

Pramipexole is an oral Dopamine agonist.

Anxiety and mood disorders

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Gronowski Center-5150 El Camino Real

Los Altos, California, 94022, United States

Location

VAPAHCS/Palo Alto MIRECC-3801 Miranda Avenue

Palo Alto, California, 94304, United States

Location

Stanford University Department of Psychiatry

Stanford, California, 94305, United States

Location

Related Publications (1)

  • Williams LM, Goldstein-Piekarski AN, Chowdhry N, Grisanzio KA, Haug NA, Samara Z, Etkin A, O'Hara R, Schatzberg AF, Suppes T, Yesavage J. Developing a clinical translational neuroscience taxonomy for anxiety and mood disorder: protocol for the baseline-follow up Research domain criteria Anxiety and Depression ("RAD") project. BMC Psychiatry. 2016 Mar 15;16:68. doi: 10.1186/s12888-016-0771-3.

Related Links

Biospecimen

Retention: NONE RETAINED

We will collect saliva samples, and in exploratory analysis focus on consideration of genes associated with neuroimaging-behavior constructs.

MeSH Terms

Conditions

Anxiety DisordersDepressionPhobia, SocialBipolar DisorderStress Disorders, Post-TraumaticPhobic Disorders

Interventions

Pramipexole

Condition Hierarchy (Ancestors)

Mental DisordersBehavioral SymptomsBehaviorBipolar and Related DisordersMood DisordersStress Disorders, TraumaticTrauma and Stressor Related Disorders

Intervention Hierarchy (Ancestors)

BenzothiazolesThiazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Leanne M Williams, PhD

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 13, 2014

First Posted

August 19, 2014

Study Start

August 11, 2013

Primary Completion

December 18, 2024

Study Completion

April 2, 2025

Last Updated

January 5, 2026

Record last verified: 2025-12

Locations