A Brain Stimulation Treatment for Depression
Summary
We are conducting a study of a non-invasive brain stimulation study for depression. This study involves repetitive transcranial magnetic stimulation, or rTMS, a treatment for depression that involves daily sessions of brain stimulation of a brain region that is involved in depression. The purpose of the study is to test whether a low dose of a specific medication called cycloserine (an antibiotic) can increase the benefit people receive from rTMS.
To do this, we are using what is called a randomized controlled trial design. The study has two parts over four weeks: 1) eligible participants will be randomly assigned to one of two groups for two weeks, and 2) all participants will receive rTMS without the study drug or placebo in what is called the 'open-label' phase. The two groups are as follows: a) rTMS + the study drug, b) rTMS + placebo. A 'placebo' is sometimes referred to as a sugar pill, and contains an inert substance.
We will monitor symptoms of depression and side effects over the course of the study, and you will have an MRI of your brain before the study and after the first two weeks of the study.
Eligibility
Eligible gender: Male, Female, Transgender, Other
Eligible ages: 18 to 65
Inclusion criteria:
-Males and females
-Aged 18-65
-Primary diagnosis of Major Depressive Disorder
-At least moderate severity depressive symptoms (HRDS >= 18)
-Did not benefit from one adequate trial of an antidepressant or unable to tolerate at least two trials of antidepressants from different classes.
-Stable medications in the four weeks prior to beginning trial
-If pursuing psychotherapy, no change to frequency or modality in the last 3 months.
-Are able to adhere to the treatment schedule
Exclusion criteria:
-Have an allergy to cycloserine
-Have an alcohol or substance use disorder within the last 3 months
-Have active suicidal ideation ( score of 4 ≥ on item 10 of MADRS)
-Are at a significant risk of harm to themselves or others
-Are currently pregnant , breast feeding or plan to become pregnant
-Have a lifetime Mini-International Neuropsychiatric Interview (MINI) diagnosis of other primary psychiatric diagnoses as assessed by a study investigator to be primary and causing greater impairment than Major Depressive Disorder.
-Have failed four or more antidepressants in the current episode.
-Are currently taking an anticonvulsant.
-Have failed a course of ECT in the current episode.
-Have a history of non-response to rTMS
-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, epilepsy, 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 concomitant major unstable medical illness, cardiac pacemaker or implanted medication pump
-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
-Have a clinically significant laboratory abnormality, in the opinion of study physician
-Are currently (or in the last 4 weeks) taking lorazepam greater than 2 mg daily (or equivalent).
-Have an exclusion criteria for MRI: Those with a history of cranial, thoracic surgery, with pacemakers, artificial joints 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, etc.
Participate
Additional information
Contact information
Study Coordinator: Jaeden Cole jaeden.cole1@ucalgary.ca 403-210-6504
Principal investigator:
Alexander McGirr
Clinical trial:
Yes
REB-ID:
REB18-2142