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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02667041
• Date of registration: 25/01/2016
• Prospective Registration: No
• Primary sponsor: University of Ottawa
• Public title: NeuroQore rTMS (Monophasic vs. Biphasic) for Major Depressive Disorder: A Randomized Controlled Pilot Trial
• Scientific title: NeuroQore Repetitive Transcranial Magnetic Monophasic vs. Biphasic Stimulation For Major Depressive Disorder: A Randomized Controlled Trial
• Date of first enrolment: May 2015
• Target sample size: 20
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02667041
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: N/A

Countries of recruitment

Canada

Key inclusion & exclusion criteria

Inclusion Criteria:

Patients will be included if they:

1. are outpatients of the ROHCG

2. are voluntary and competent to consent to treatment

3. have a confirmed DSM-IV diagnosis of unipolar major depressive disorder

4. are male or female

5. are between the ages of 18 and 75

6. 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

7. have a score > 22 on the MADRS

8. have had no increase or initiation of any psychotropic medication in the 4 weeks prior
to screening

9. are able to adhere to the treatment schedule

10. pass the TMS safety screening questionnaire (TASS)

11. have normal thyroid functioning based on pre-study blood work

Exclusion Criteria:

Patients will be excluded if they:

1. 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

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 DSM-IV diagnosis of bipolar I or II disorder, schizophrenia,
schizoaffective disorder, schizophreniform disorder, delusional disorder, or current
psychotic symptoms

6. 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

7. have failed a course of ECT in the current episode or previous episode

8. have received rTMS for any previous indication due to the potential compromise of
subject blinding

9. 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

10. 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

11. 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

12. clinically significant laboratory abnormality, in the opinion of the investigator

13. 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

14. non-correctable clinically significant sensory impairment (i.e., cannot hear well
enough to cooperate with interview)

15. failure of 3 or more adequate trials of medications of different drug classifications
in the current episode



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Depressive Disorder, Major

Intervention(s)

Device: NeuroQore rTMS Device

Primary Outcome(s)

Montgomery-Åsberg Depression Rating Scale (MADRS) scores [Time Frame: Six weeks]

Secondary ID(s)

2015014

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

NeuroQore Inc.