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Non-invasive Brain Stimulation

Theta Burst Stimulation for Depression

N/A

Recruiting

Led By Sara Tremblay, PhD

Research Sponsored by The Royal Ottawa Mental Health Centre

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Voluntary and competent to consent to study

Primary and/or predominant diagnosis of major depressive episode without psychotic features (confirmed by a Mini-International Neuropsychiatric Interview)

Must not have

Have a specific contraindication for TMS (e.g., personal history of epilepsy or seizure, metallic head implant, pacemaker)

Have a concomitant major unstable medical or neurologic illness (e.g. uncontrolled diabetes or renal dysfunction)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will study the effectiveness of a new, shorter treatment for major depression, comparing it to a standard treatment.

Who is the study for?

This trial is for adults with major depression who haven't improved after 1-7 antidepressant treatments. They must be stable on current medications or therapy for four weeks, have moderate symptoms, and score ≥24 on the MMSE if over 65. Exclusions include substance abuse, unstable medical conditions, pregnancy, TMS contraindications like epilepsy, and recent ECT failure.

What is being tested?

The study compares two types of Theta burst stimulation (TBS) treatments: unilateral left TBS versus bilateral TBS. It aims to determine which is more effective in treating major depression including cases with comorbid anxiety and establishes an effective maintenance protocol.

What are the potential side effects?

While not specified here, common side effects of rTMS/TBS may include headache, scalp discomfort at the treatment site, tingling or spasms of facial muscles, lightheadedness. Serious risks are rare but can include seizures.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am willing and able to agree to participate in the study.

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I have been diagnosed with major depression without psychosis.

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My mental state score is good for my age.

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I have been diagnosed with major depression without psychosis.

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My mental state score is above 24, and I am 65 or older.

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My depression is moderate as measured by a specific test.

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My depression hasn't improved after 1 to 7 treatments.

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My depression hasn't improved after 1 to 7 antidepressant trials.

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My depression is moderate, as shown by my HRSD-17 score of 15 or more.

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I am willing and able to agree to participate in the study.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have epilepsy, seizures, metallic head implants, or a pacemaker.

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I do not have any major uncontrolled illnesses like diabetes or kidney problems.

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I am not willing to keep taking my current antidepressants.

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ECT didn't work for my current depression episode.

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I am taking more than 1 mg of lorazepam or its equivalent.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Remission - Maintenance Phase (Hamilton Rating Scale for Depression-17 Score)

Remission - Treatment Phase (Hamilton Rating Scale for Depression-17 Score)

Response - Maintenance Phase (Hamilton Rating Scale for Depression-17 score)

+1 more

Secondary study objectives

Remission - Maintenance Phase Quick Inventory of Depression Symptomology-Self Report)

Remission - Treatment Phase (Quick Inventory of Depression Symptomology-Self Report)

Mental Depression

+1 more

Other study objectives

Cortical Activity - Maintenance Phase

Cortical Activity - Treatment Phase

Cortical Activity in Motor Cortex

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Active Control

Group I: Maintenance Phase: FlexibleActive Control1 Intervention

The flexible maintenance protocol will be based on symptom emergence. Participants will receive a fixed TBS (2x/week) schedule for the first month. For the following months (2-6), they will come in for an assessment (HRSD-17) to determine how many TBS sessions (0, 1, or 2) they receive on a flexible basis.

Group II: Bilateral TBSActive Control1 Intervention

Intermittent Theta Burst Stimulation (iTBS) will be applied to the left DLPFC and continuous TBS (cTBS) will be applied to the right DLPFC. Participants will receive daily sessions (Mon-Fri) for 4 to 6 weeks (stop at 4 weeks if remission is achieved).

Group III: Unilateral TBSActive Control1 Intervention

Intermittent Theta Burst Stimulation (iTBS) will be applied to the left DLPFC. Realistic sham continuous TBS (cTBS-sham) will be applied to the right DLPFC. Participants will receive daily sessions (Mon-Fri) for 4 to 6 weeks (stop at 4 weeks if remission is achieved).

0 / 15Eligibility criteria met