Major Depressive Disorder Clinical Trial
Official title:
Personalized Neuromodulation Targeting Dysregulated Motivational Responses Underlying Social Avoidance Behavior
Verified date | February 2024 |
Source | Auburn University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to use transcranial magnetic stimulation (TMS) to better understand the neural circuits associated with social motivation. Participant includes four study visits each that range from 1.5 - 3.0 hours in duration over approximately a one month period. The first study visit involves answering survey questions, a clinical interview, and computer tasks. The second study visit involves a magnetic resonance imaging (MRI) scan, computer tasks, and a brief TMS protocol. The second and third study visits involve a full session of TMS followed by an MRI scan and computer tasks. Adults in the Auburn/Apelika area who avoid social situations, experience symptoms of depression or social anxiety, and are between 25 years old and 50 years old are eligible to participate.
Status | Not yet recruiting |
Enrollment | 40 |
Est. completion date | September 2029 |
Est. primary completion date | September 2029 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 25 Years to 50 Years |
Eligibility | Inclusion Criteria: - A diagnosis of Major Depressive Disorder OR a diagnosis of Social Anxiety Disorder (assessed/confirmed at screening visit). - Scoring above clinical threshold on a measure of social avoidant behavior (assessed/confirmed at screening visit). Exclusion Criteria: - Unstable medication regimen (i.e., changes in medication or dosage in past 3 months). - Current or lifetime diagnosis of Bipolar Disorder. - A diagnosis of substance use disorder within past 12 months. - A diagnosis of psychotic-spectrum disorder such as Schizophrenia. - Pregnancy or probable pregnancy. - Medical illness or medical treatment that would preclude or inhibit study participation. - Neurological disorder or prior neurosurgical procedure. - History of seizures or head trauma. - Metal implants or objects within body (e.g., pacemaker). |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
---|---|
Auburn University |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Social motivation | Motivational responses to facial expressions as measured by the Social Approach Avoidance Paradigm (SAAP; Evans, Esterman, & Britton, 2022). In the SAAP, participants self-report how much they would like to approach or avoid emotional facial expressions. | Immediately post-intervention | |
Primary | Neural circuit function | Brain connectivity during motivational responses to facial expression during the Social Approach-Avoidance Paradigm (SAAP; Evans, Esterman, & Britton, 2022) and during resting state conditions. In the SAAP, participants self-report how much they would like to approach or avoid emotional facial expressions. During resting state conditions, participants simply lie still with their eyes open without completing any type of task. | Immediately post-intervention |
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