| Eligibility |
Inclusion Criteria:
- Outpatients.
- Men and women 22-68 years of age.
- Primary Diagnostic and Statistical Manual (DSM-V) diagnosis of Major Depression,
single or recurrent episode confirmed by the Quick Structured Clinical Interview for
the DSM-5 Disorders (QuickSCID-5), with the additional requirements of a current
episode =4 weeks and CGI-S =4.
- Current depressive episode is less than 5 years in duration (the definition of an
episode is demarcated by a period of =2 months in which the patient did not meet full
criteria for the DSM-V definition of major depressive episode);
- Total HDRS-21 =20 and Item 1 score =2 at the screening visit;
- The patient did not respond to at least one antidepressant treatment, i.e., a minimum
of 1 and a maximum of 4 antidepressant drug trials, of adequate dose and duration
(defined as a minimum level of 3 on the Antidepressant Treatment History Form - Short
Form (ATHF-SF)) in the current episode; or Patients who have not completed
antidepressant trials of adequate dose and duration (defined as a level of 1-2 on the
ATHF-SF) due to intolerance to therapy, if they have demonstrated intolerance to 2 or
more antidepressant medications in the current episode.
- Capable and willing to provide informed consent
- Able to adhere to the treatment schedule.
- Patient is stable on medication for 2 month and is not expected to change medication
during the study period.
- Satisfactory safety screening questionnaire for transcranial magnetic stimulation.
Exclusion Criteria:
- Investigators, site personnel directly affiliated with this study, and their immediate
families (immediate family is defined as a spouse, parent, child or sibling, whether
by birth or legal adoption);
- Individuals diagnosed by the Investigator with the following conditions (current
unless otherwise stated):
- Depression secondary to a general medical condition, or substance-induced;
- Substance abuse disorder within the past 3 months (except nicotine and caffeine). Note
that use of cannabis for medical reasons in a stable regimen is permitted as long as
the investigator excludes abuse of the substance.
- Any psychotic disorder (lifetime), including schizoaffective disorder or major
depression with psychotic features or Bipolar disorder.
- Post-traumatic stress disorder (current or within the past year)
- Current (within 12 months of baseline) generalized anxiety disorder, panic disorder or
social anxiety disorder as assessed by the investigator to be primary, causing a
higher degree of distress or impairment than MDD.
- Presence (within 12 months of baseline) of a personality disorder (such as antisocial,
schizotypal, histrionic, borderline, narcissistic) as assessed by the investigator to
be primary, causing a higher degree of distress or impairment than MDD.
- Individuals with a 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 Electroconvulsive T
Therapy (ECT) or febrile seizures
- History of cerebrovascular accident
- Transient ischemic attack within two years
- Cerebral aneurysm
- Dementia
- Mini Mental State Exam score of less than or equal to 24
- Parkinson's disease
- Huntington's chorea
- Multiple sclerosis
- Individuals with a first-degree relative family history of seizure.
- ECT treatment within 3 months prior to the screening visit
- History of treatment with Vagus Nerve Stimulation (VNS)
- History of treatment with Deep Brain Stimulation (DBS)
- Use of any investigational drug within 4 weeks of the baseline visit
- Present suicidal risk as assessed by the investigator or significant suicide risk
based on HDRS-21 item 3 score of 3 or 4, or significant suicide risk as assessed using
the Scale for Suicide Ideation (SSI), or a history of attempted suicide in the last
year.
- Any self-inflicted harm in the past 3 months not in the context of suicidal ideation.
- Conductive, ferromagnetic or other magnetic-sensitive metals implanted in the head
(excluding the mouth) or within 10 cm of the treatment coil (e.g., cochlear implants,
implanted electrodes/stimulators, aneurysm clips or coils, stents, bullet fragments,
shrapnel, surgical clips, fragments from welding or metal work).
- Individuals who have cardiac pacemakers or active implantable
electrodes/neurostimulators within 30 cm of the treatment coil.
- 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 rTMS trial
- Clinically significant medical condition in the opinion of the Investigator.
- Known or suspected pregnancy
- Women who are breast-feeding
- Women of childbearing potential and not using a medically accepted form of
contraception when engaging in sexual intercourse.
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