Clinical trial NCT02220309: Stanford RAD-AT Study (Research on Anxiety and Depression - Anhedonia Treatment)
Official title: Neural Dimensions of Threat Reactivity and Regulation for Understanding Anxiety
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Anxiety
Depression
Keywords: Anxiety
Depression
Social Anxiety Disorder
Bipolar disorder II
PTSD
GAD
Phobia
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2014-08-19
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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).

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

Eligibility criteria: 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)

Primary outcomes:
measure: Assessments of symptoms and daily functioning
timeFrame: 12 weeks
measure: Brain imaging
timeFrame: 12 weeks
measure: Cognitive assessment
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Los Altos
country: United States
facility: Gronowski Center-5150 El Camino Real
state: California
city: Palo Alto
country: United States
facility: VAPAHCS/Palo Alto MIRECC-3801 Miranda Avenue
state: California
city: Stanford
country: United States
facility: Stanford University Department of Psychiatry
state: California
Study officials:
affiliation: Stanford University
name: Leanne M Williams, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.