TMS R21 – Baylor Study

Purpose: The main objective of this project is to investigate TMS-EEG measures as an in vivo, noninvasive neurophysiological probe to investigate PFC cortical excitability in TRD patients and their relationship to clinical improvements following rTMS treatment.

Exclusion Criteria:

• Diagnosed with intellectual disability, eg. Mental retardation, neurodegenerative diseases, eg. early onset neurocognitive disturbances such as frontotemporal dementia or behavioral disorders, eg. adult onset Attention Deficit Hyperactivity Disorder
• Taking regular mood stabilizers (excluding lithium). Plans to change any medication use or dosage while enrolled in the study trial.
• Healthy Controls: Positive urine drug screen for any substance. MDD Patients: Positive urine drug screen excluding benzodiazepines. MDD patients may be on a dose of 2 mg or less of Ativan or an equivalent dose. MDD patients who test positive for marijuana will be allowed to retest one time 3 weeks after the initial testing. If it is still positive, they will be excluded from the study
• Lifetime diagnosis with Bipolar Disorder (BD), psychotic disorder, severe personality disorders, or substance use disorder in the past 6 months
• Current major medical problems that affect brain anatomy or function, history of seizures or head injury with loss of consciousness for any period
• Pregnancy or Breast feeding. All females in reproductive age will undergo pregnancy tests
• Not meeting TMS/MRI safety criteria
• Unable to understand the design and requirements of the study
• Unable to sign informed consent for any reason

Inclusion Criteria:

• Male and Female subjects, ages 18-65 years
• Meet criteria for Major depression (Current major depressive episode of at least 4 weeks duration with Hamilton Depression Rating Scale (HDRS-17) score of ≥ 14. Diagnosis will be determined by DSM-5
• TRD (defined as at least two unsuccessful trials of antidepressants at an adequate dose for at least 6