Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06274112
Other study ID # 1K23MH135222
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date September 2024
Est. completion date September 2029

Study information

Verified date February 2024
Source Auburn University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

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).

Study Design


Intervention

Device:
TMS
TMS will be administered in either an active format that induces neuromodulatory effects or a sham comparison format that does not induce neuromodulatory effects.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Auburn University

Outcome

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
See also
  Status Clinical Trial Phase
Recruiting NCT05537558 - Precision Medicine for the Prediction of Treatment (PROMPT) Response (PROMPT)
Terminated NCT02192099 - Open Label Extension for GLYX13-C-202, NCT01684163 Phase 2
Completed NCT03142919 - Lipopolysaccharide (LPS) Challenge in Depression Phase 2
Recruiting NCT05547035 - Identification of Physiological Data by a Wearable Monitor in Subjects Suffering From Major Depression Disorders N/A
Terminated NCT02940769 - Neurobiological Effects of Light on MDD N/A
Recruiting NCT05892744 - Establishing Multimodal Brain Biomarkers for Treatment Selection in Depression Phase 4
Recruiting NCT05537584 - SMART Trial to Predict Anhedonia Response to Antidepressant Treatment Phase 4
Active, not recruiting NCT05061706 - Multicenter Study of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder Phase 3
Completed NCT04479852 - A Study of the Safety and Efficacy of SP-624 in the Treatment of Adults With Major Depressive Disorder Phase 2
Recruiting NCT04032301 - Repeated Ketamine Infusions for Comorbid PTSD and MDD in Veterans Phase 1
Recruiting NCT05527951 - Enhanced Measurement-Based Care Effectiveness for Depression (EMBED) Study N/A
Completed NCT03511599 - Cycloserine rTMS Plasticity Augmentation in Depression Phase 1
Recruiting NCT04392947 - Treatment of Major Depressive Disorder With Bilateral Theta Burst Stimulation N/A
Recruiting NCT05895747 - 5-HTP and Creatine for Depression R33 Phase Phase 2
Recruiting NCT05273996 - Predictors of Cognitive Outcomes in Geriatric Depression Phase 4
Recruiting NCT05813093 - Interleaved TMS-fMRI in Ultra-treatment Resistant Depression N/A
Recruiting NCT05135897 - The Neurobiological Fundaments of Depression and Its Relief Through Neurostimulation Treatments
Enrolling by invitation NCT04509102 - Psychostimulant Augmentation of Repetitive TMS for the Treatment of Major Depressive Disorder Early Phase 1
Recruiting NCT06026917 - Assessing Dopamine Transporter Occupancy in the Patients With Depression Brain With Toludesvenlafaxine Hydrochloride Extended-Release Tablets Using 11C-CFT Positron Emission Tomography (PET) Phase 4
Recruiting NCT06145594 - EMA-Guided Maintenance TMS for Depression N/A