Comparing two methods of theta burst stimulation for major depression

A Naturalistic Study Comparing Uni- and Bi-lateral Theta Burst Stimulation in Major Depression

This study is testing whether two different ways of using theta burst stimulation can help people with major depression feel better.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 256 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: The Royal Ottawa Mental Health Centre (other)
• Locations: 1 site (Ottawa, Ontario)
• Trial ID: NCT04142996 on ClinicalTrials.gov

What this trial studies

This study investigates the efficacy of bilateral versus unilateral theta burst stimulation (TBS) in treating major depressive episodes. TBS is a novel form of repetitive transcranial magnetic stimulation (rTMS) that significantly reduces the duration of treatment sessions while aiming to maintain clinical efficacy. The trial will be randomized and double-blinded, assessing neurobiological markers of response and including a maintenance phase for responders. The study aims to fill gaps in current knowledge regarding TBS treatment for both unipolar and bipolar depression, as well as other psychiatric comorbidities.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with a primary diagnosis of major depressive episode who have not responded to previous antidepressant treatments.

Not a fit: Patients with psychotic features in their depressive episode or those who have not adhered to treatment schedules may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more efficient and effective treatment option for patients suffering from major depression.

How similar studies have performed: While TBS is a promising new approach, this specific comparison of bilateral and unilateral TBS has not been extensively studied, making it a novel investigation.

Eligibility criteria

Inclusion Criteria:

1. voluntary and competent to consent to study,
2. female or male aged 18 years old or older,
3. can speak and read English and/or French
4. primary and/or predominant diagnosis of major depressive episode without psychotic features in the current depressive episode (confirmed by a Mini-International Neuropsychiatric Interview),
5. depressive symptoms have not improved after ≥ 1 adequate dose of antidepressant trial in the current depressive episode,
6. moderate symptoms in the current depressive episode as indexed by a score of at least 15 at the 17-item Hamilton Rating Scale for Depression (HRSD-17),
7. have been referred to rTMS treatment by their treating physician, and took a free and informed decision to follow this treatment,
8. are able to adhere to treatment schedule,
9. have received a stable psychiatric medication (including prescribed cannabis) or psychotherapy regimen for at least four weeks prior to entering the trial,
10. have an education-adjusted score of ≥ 24 at the Mini-Mental State Evaluation (MMSE) if are aged ≥ 65.

Exclusion Criteria:

1. current or past (\< 3 months) substance (excluding caffeine or nicotine) or alcohol abuse/dependence, as defined in the Diagnostic and Statistical Manual 5th Edition (DSM-5) criteria. Based on the DSM-5 criteria, mild cannabis or alcohol use would be permissible in the past 3 months, moderate to severe would be an exclusion
2. current use of illegal substances or recreational cannabis
3. have a concomitant major unstable medical or neurologic illness (e.g. uncontrolled diabetes or renal dysfunction),
4. organic cause to the depressive symptoms (e.g. thyroid dysfunctions), determined by the referring physician
5. acute suicidality or threat to life from self-neglect,
6. are pregnant or breastfeeding, or thinking of becoming pregnant during course of treatment,
7. have a specific contraindication for TMS (e.g., personal history of epilepsy or seizure, metallic head implant, pacemaker),
8. unwilling to maintain current antidepressant regimen,
9. are taking more than 1 mg of lorazepam or equivalent,
10. any other condition that, in the opinion of the investigators, would adversely affect the participant's ability to complete the study,
11. have failed a course of electroconvulsive therapy (ECT) within the current depressive episode due to the lower likelihood of response to rTMS.If they have had failed ECT in the past, this does not exclude them

Where this trial is running

Ottawa, Ontario

• The Royal Ottawa Mental Health Centre — Ottawa, Ontario, Canada (RECRUITING)

Study contacts

• Principal investigator: Sara Tremblay, PhD — The Royal Ottawa Mental Health Centre
• Study coordinator: Stacey Shim, MSc

Conditions: Major Depressive Episode