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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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

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 outcome measures

Cortical Activity - Maintenance Phase

Cortical Activity - Treatment Phase

Cortical Activity in Motor Cortex

+2 more

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 / 10Eligibility criteria met

Find a Location

Who is running the clinical trial?

The Royal Ottawa Mental Health CentreLead Sponsor

18 Previous Clinical Trials

1,840 Total Patients Enrolled

Sara Tremblay, PhDPrincipal InvestigatorThe Royal Ottawa Mental Health Centre

2 Previous Clinical Trials

232 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current participant count for this medical experiment?

"Affirmative. Clinicaltrials.gov documents that this medical trial, first published on December 12th 2019, is currently recruiting participants from one location. A total of 256 patients need to be enrolled in the research study."

Answered by AI

Is this research initiative still welcoming participants?

"According to the information hosted by clinicaltrials.gov, this trial is actively recruiting and was initially posted on December 12th 2019 with a most recent edit occurring on June 7th 2022."

Answered by AI

What purpose does this research endeavor seek to achieve?

"The primary metric of this 6-month trial is Remission - Treatment Phase (Hamilton Rating Scale for Depression-17 Score). Secondary outcomes include Response - Maintenance Phase and Response - Treatment Phase, both assessed by the Quick Inventory of Depression Symptomology-Self Report. Lastly, there's also a measure for Remission as defined by a score ≤ 6 on the same scale."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Comparing Uni- and Bi-lateral TBS in Major Depression

2019. "Comparing Uni- and Bi-lateral TBS in Major Depression". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04142996.

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