Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID04142996

A Naturalistic Study Comparing Unilateral and Bilateral Theta Burst Stimulation in Major Depression

Led by The Royal Ottawa Mental Health Centre · Updated on 2023-12-04

256

Participants Needed

1

Research Sites

N/A

Total Duration

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AI-Summary

What this Trial Is About

Researchers are evaluating the effects of theta burst stimulation (TBS), a newer form of repetitive transcranial magnetic stimulation (rTMS), in treating people with major depressive episodes. This study compares the effectiveness of stimulating one side (unilateral) versus both sides (bilateral) of the brain's frontal cortex. It also explores brain activity changes and neural markers that may predict treatment response. Additionally, the study examines a flexible maintenance treatment schedule to help prevent relapse over six months in those who respond to initial therapy. Participants will receive TBS treatments daily on weekdays for 4 to 6 weeks, stopping at 4 weeks if remission is achieved. Two groups receive either unilateral or bilateral TBS: unilateral involves intermittent TBS on the left side with sham treatment on the right, while bilateral delivers active TBS to both sides. Responders enter a 6-month maintenance phase with a flexible schedule based on symptom assessments using the Hamilton Rating Scale for Depression-17. Maintenance frequency starts at twice weekly, then adjusts monthly through clinical evaluations. Throughout the study, participants undergo regular assessments including depression rating scales and brain activity measurements using TMS-EEG. Researchers track response and remission rates at key points: end of treatment and after 6 months of maintenance. Safety and treatment adherence are monitored closely. The total participation time can last up to about 7.5 months including treatment and maintenance. This study aims to better understand how TBS can be optimized for depression and how to maintain its benefits over time.

CONDITIONS

Brief Title

Comparing Uni- and Bi-lateral TBS in Major Depression

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Voluntary and competent to consent to the study
  • Female or male aged 18 years or older
  • Able to speak and read English and/or French
  • Primary or predominant diagnosis of major depressive episode without psychotic features confirmed by a Mini-International Neuropsychiatric Interview
  • Depressive symptoms not improved after at least one adequate antidepressant trial in the current episode
  • Moderate depressive symptoms with a score of at least 15 on the 17-item Hamilton Rating Scale for Depression (HRSD-17)
  • Referred to rTMS treatment by a treating physician and chose to undergo this treatment
  • Able to adhere to the treatment schedule
  • On stable psychiatric medication or psychotherapy regimen for at least four weeks prior to enrollment
  • Education-adjusted Mini-Mental State Evaluation (MMSE) score of 24 or higher if aged 65 or older
Not Eligible

You will not qualify if you...

  • Current or past (within 3 months) substance or alcohol abuse/dependence except mild cannabis or alcohol use
  • Current use of illegal substances or recreational cannabis
  • Major unstable medical or neurological illness (e.g., uncontrolled diabetes or renal dysfunction)
  • Organic causes for depressive symptoms (e.g., thyroid dysfunction)
  • Acute suicidality or life threat from self-neglect
  • Pregnant, breastfeeding, or planning pregnancy during treatment
  • Specific contraindications for TMS (e.g., epilepsy, seizures, metallic head implant, pacemaker)
  • Unwilling to maintain current antidepressant regimen
  • Taking more than 1 mg of lorazepam or equivalent
  • Any condition that may affect ability to complete the study
  • Failed electroconvulsive therapy (ECT) during current depressive episode (past failures allowed)

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 4 to 6 weeks

Participants receive daily Theta Burst Stimulation (TBS) sessions on weekdays for 4 to 6 weeks. Treatment stops at 4 weeks if remission is achieved; non-remitters continue for up to 6 weeks total.

20 to 30 visits (in-person, weekdays)

Maintenance

Duration - 6 months

Participants who respond to treatment enter a 6-month flexible maintenance phase with TBS sessions scheduled based on symptom assessments.

Twice-weekly visits for month 1; weekly or biweekly visits for months 2 to 5 depending on symptom assessments; 1 visit in month 6

Trial Site Locations

Total: 1 location

1

The Royal Ottawa Mental Health Centre

Ottawa, Ontario, Canada, K1Z 7K4

Actively Recruiting

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Research Team

S

Stacey Shim, MSc

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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Published Research Related To This Trial

A naturalistic study comparing the efficacy of unilateral and bilateral sequential theta burst stimulation in treating major depression - the U-B-D study protocol.

Molly Watson, Arthur R Chaves, Abir Gebara...

https://pubmed.ncbi.nlm.nih.gov/37817124