NeuroQore rTMS (Monophasic vs. Biphasic) for Major Depressive Disorder: A Randomized Controlled Pilot Trial

Inclusion criteria

Patients will be included if they:

• are outpatients of the ROHCG
• are voluntary and competent to consent to treatment
• have a confirmed DSM-IV diagnosis of unipolar major depressive disorder
• are male or female
• are between the ages of 18 and 75
• have failed to achieve a clinical response to an adequate dose of an antidepressant in the current episode OR have been unable to tolerate at least 2 separate trials of antidepressants of inadequate dose and duration
• have a score > 22 on the MADRS
• have had no increase or initiation of any psychotropic medication in the 4 weeks prior to screening
• are able to adhere to the treatment schedule
• pass the TMS safety screening questionnaire (TASS)
• have normal thyroid functioning based on pre-study blood work

Exclusion criteria

Patients will be excluded if they:

• have a history of substance dependence or abuse within the last 3 months or current substance use as indicated by a positive urine drug screen
• have a concomitant major unstable medical illness, cardiac pacemaker or implanted medication pump
• have active suicidal intent
• are pregnant
• have a lifetime DSM-IV diagnosis of bipolar I or II disorder, schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder, or current psychotic symptoms
• have a DSM-IV 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, or personality disorder, assessed by a study investigator to be primary and causing greater impairment than MDD
• have failed a course of ECT in the current episode or previous episode
• have received rTMS for any previous indication due to the potential compromise of subject blinding
• 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 or equal to 5 minutes
• 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
• 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
• clinically significant laboratory abnormality, in the opinion of the investigator
• currently (or in the last 4 weeks) take more than lorazepam 2 mg daily (or equivalent) or any dose of an anticonvulsant due to the potential to limit rTMS efficacy
• non-correctable clinically significant sensory impairment (i.e., cannot hear well enough to cooperate with interview)
• failure of 3 or more adequate trials of medications of different drug classifications in the current episode