Stanford Accelerated Intelligent Neuromodulation Therapy for Treatment-Resistant Depression (SAINT-TRD)

Exclusion Criteria

• •Female of childbearing potential who is not willing to use one of the specified forms of birth control during the study.
• •Female that is pregnant or breastfeeding.
• •Female with a positive pregnancy test at participation.
• •Total HAMD17 score of \< 20 at the screen or baseline visits.
• •Total MADRS score of \< 20 at the screen or baseline visits.
• •Total BDI-II score of \< 20 at the screen or baseline visits.
• •Current diagnosis of a Substance Use Disorder (Abuse or Dependence, as defined by DSM-IV-TR), with the exception of nicotine dependence, at screening or within six months prior to screening.
• •Current diagnosis of Axis I disorders other than Dysthymic Disorder, Generalized Anxiety Disorder, Social Anxiety Disorder, Panic Disorder, Agoraphobia, or Specific Phobia (unless one of these is comorbid and clinically unstable, and/or the focus of the participant's treatment for the past six months or more).
• •History of schizophrenia or schizoaffective disorders, or any history of psychotic symptoms in the current or previous depressive episodes.
• •Any Axis I or Axis II Disorder, which at screening is clinically predominant to their MDD or has been predominant to their MDD at any time within six months prior to screening.
• •Considered at significant risk for suicide during the course of the study.
• •Cognitive impairment (as noted by previous diagnoses-including dementia).
• •Has a clinically significant abnormality on the screening examination that might affect safety, study participation, or confound interpretation of study results.
• •Participation in any clinical trial with an investigational drug or device within the past month or concurrent to study participation.
• •Any current or past history of any physical condition which in the investigator's opinion might put the subject at risk or interfere with study results interpretation.
• •History of positive screening urine test for drugs of abuse at screening: cocaine, amphetamines, barbiturates, opiates.
• •Current (or chronic) use of opiates.
• •History of epilepsy.
• •History of rTMS exposure.
• •History of any implanted device or psychosurgery for depression.
• •Any history of ECT (greater than 8 sessions) without meeting responder criteria
• •History of shrapnel or metal in the head or skull.
• •"Low Treatment Refractory" using the Maudsley staging method.
• •History of cardiovascular disease or cardiac event.
• •History of OCD.
• •History of autism spectrum disorder.
• •History of intractable migraine
• •History of independent sleep disorder.