| Eligibility |
TRD Patient Inclusion Criteria:
Patients will be included if they:
1. are outpatients
2. are voluntary and competent to consent to treatment
3. have a Mini-International Neuropsychiatric Interview (MINI) confirmed diagnosis of
MDD, single or recurrent
4. are between the ages of 18 and 80 years
5. have failed to achieve a clinical response to at least one adequate dose of an
antidepressant based on an Antidepressant Treatment History Form (ATHF) score of score
= 3 in the current episode OR have been unable to tolerate at least 2 separate trials
of antidepressants of inadequate dose and duration (ATHF 1 or 2)
6. have a score = 22 on the IDS item
7. have had no increase or initiation of any psychotropic medication in the 4 weeks prior
to initiation of rTMS
8. able to adhere to the treatment schedule
9. pass the TMS adult safety screening (TASS) questionnaire
First Episode Depression Inclusion Criteria:
Patients will be included if they:
1. are outpatients
2. are voluntary and competent to consent to treatment
3. have a Mini-International Neuropsychiatric Interview (MINI) confirmed diagnosis of
MDD, single or recurrent
4. are between the ages of 18 and 80 years
5. have never received and adequate antidepressant trial and are not currently taking any
antidepressant.
6. have a score = 12 on the IDS item
7. are on no psychotropic medication for the 4 weeks prior to initiation of rTMS, with
the exception of lorazepam up to 2mg or equivalent dose of benzodiazepine or
prescribed sleeping aids including (zopiclone up to 15mg/d, zolpidem up to 10mg/d).
8. able to adhere to the treatment schedule
9. pass the TMS adult safety screening (TASS) questionnaire
Patient Exclusion Criteria:
Patients are excluded if they:
1. have a history of substance dependence or abuse within the last 3 months
2. have a concomitant major unstable medical illness, cardiac pacemaker or implanted
medication pump
3. have active suicidal intent
4. are pregnant
5. have a lifetime Mini-International Neuropsychiatric Interview (MINI) diagnosis of
bipolar I or II disorder, schizophrenia, schizoaffective disorder, schizophreniform
disorder, delusional disorder, or current psychotic symptoms
6. have a MINI diagnosis of obsessive compulsive disorder, post-traumatic stress disorder
(current or within the last year), anxiety disorder (generalized anxiety disorder,
social anxiety disorder, panic disorder), or dysthymia, assessed by a study
investigator to be primary and causing greater impairment than MDD
7. have a diagnosis of any personality disorder, and assessed by a study investigator to
be primary and causing greater impairment than MDD
8. have failed a course of ECT in the current episode or previous episode
9. have received rTMS for any previous indication due to the potential compromise of
expectancy effects
10. have any significant neurological disorder or insult including, but not limited to:
any condition likely to be associated with increased intracranial pressure, space
occupying brain lesion, any history of seizure except those therapeutically induced by
ECT, cerebral aneurysm, Parkinson's disease, Huntington's chorea, multiple sclerosis,
significant head trauma with loss of consciousness for greater than 5 minutes
11. have an intracranial implant (e.g., aneurysm clips, shunts, stimulators, cochlear
implants, or electrodes) or any other metal object within or near the head, excluding
the mouth, that cannot be safely removed
12. If participating in psychotherapy, must have been in stable treatment for at least 3
months prior to entry into the study, with no anticipation of change in the frequency
of therapeutic sessions, or the therapeutic focus over the duration of the study
13. have a clinically significant laboratory abnormality, in the opinion of the one of the
principal investigators
14. are currently (or in the last 4 weeks) taking lorazepam greater than 2 mg daily (or
equivalent) or any dose of an anticonvulsant, due to the potential to limit rTMS
efficacy
15. have a non-correctable clinically significant sensory impairment (i.e., cannot hear
well enough to cooperate with interview).
16. have failed more than 5 adequate trials of medication in the current episode.
17. Exclusion criteria for MRI: Those with a history of cranial, thoracic or abdominal
surgery, with pacemakers, artificial joins or other metallic implants will be excluded
from the MRI scan. Subjects that have agreed to participate in the MRI portion of the
study will be pre- screened for any potential metal fragments in the body
(particularly in the orbits) if they have had any history of doing metal work or have
been involved in use/deployment of ammunitions/explosives, welding, piping etc.). In
these cases a CT scan will be performed prior to the MRI scan
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Healthy Control Inclusion Criteria
Participants will be included if they:
1. are voluntary and competent to consent to the study
2. are between the ages of 18 and 80
3. are fluent in English, sufficient to complete interviews and cognitive testing
4. have no history of Axis I or Axis II disorders, as determined by the MINI
5. pass the TMS adult safety screening (TASS) questionnaire
Healthy Control Exclusion Criteria:
Participants will be excluded if they:
1. have a lifetime Mini-International Neuropsychiatric Interview (MINI) diagnosis of
bipolar I or II disorder, schizophrenia, schizoaffective disorder, schizophreniform
disorder, delusional disorder, or current psychotic symptoms
2. have a MINI diagnosis of obsessive compulsive disorder, post-traumatic stress disorder
(current or within the last year), anxiety disorder (generalized anxiety disorder,
social anxiety disorder, panic disorder), dysthymia or any personality disorder
3. have history of bipolar disorder or psychosis in first degree relative (parents,
siblings, offspring)
4. are unable to provide family history of biological family (i.e., adopted persons are
not eligible)
5. have a history of substance dependence within the last 3 months
6. have a concomitant major unstable medical illness
7. have any significant neurological disorder or insult including, but not limited to:
any condition likely to be associated with increased intracranial pressure, space
occupying brain lesion, cerebral aneurysm, Parkinson's disease, Huntington's chorea,
multiple sclerosis, significant head trauma with loss of consciousness for greater
than or equal to 5 minutes
8. have a non-correctable clinically significant sensory impairment (i.e., cannot hear
well enough to cooperate with interview).
9. have a personal or family history of seizures
10. Exclusion criteria for MRI: Those with a history of cranial, thoracic or abdominal
surgery, with pacemakers, artificial joins or other metallic implants will be excluded
from the MRI scan. Those who are pregnant will also be excluded from the MRI scan.
Subjects that have agreed to participate in the MRI portion of the study will be
pre-screened for any potential metal fragments in the body (particularly in the
orbits) if they have had any history of doing metal work or have been involved in
use/deployment of ammunitions/explosives, welding, piping etc.)
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