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Theta Burst Stimulation for Adolescent Depression

N/A

Waitlist Available

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

Ages 16-19 years old

Depressive symptoms have not improved after ≥ 1 adequate dose of antidepressant in the current depressive episode

Must not have

Have a specific contraindication to TMS and/or MRI (e.g., personal history of epilepsy or seizures, metal head implant, pacemaker)

Concomitant unstable major medical or neurological disease (e.g., uncontrolled diabetes or renal dysfunction)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up administered at screening, weekly for 2 weeks in accelerated group, every 3rd week for 6 weeks in once/daily (standard) group, as well as 2-, 4- and 12-weeks post-treatment course for both treatment protocols.

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to study the effectiveness of a new treatment called Theta burst stimulation (TBS) for major depression in adolescents. They want to compare how well a new accelerated, three times a day T

Who is the study for?

This trial is for adolescents with major depression who haven't improved with standard treatments. Participants must be able to undergo fMRI scans and TBS sessions. Specific details on inclusion and exclusion criteria are not provided, but typically these would outline health conditions or medications that might interfere with the treatment.

What is being tested?

The study tests if using Theta Burst Stimulation (TBS), a type of brain stimulation therapy, three times a day works better than once daily for treating depression in adolescents. It's guided by fMRI scans to target specific brain areas.

What are the potential side effects?

While side effects aren't detailed here, common ones for TBS may include headache, scalp discomfort at the stimulation site, lightheadedness, or seizures in very rare cases.

Eligibility Criteria

Inclusion Criteria

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

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I am between 16 and 19 years old.

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My depression hasn't improved after trying at least one antidepressant.

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My current depression symptoms are moderate, as shown by my CDRS-R score.

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My main diagnosis is depression without psychosis, confirmed by a specific interview.

Exclusion Criteria

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

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I cannot have TMS or MRI due to conditions like epilepsy or having a metal implant.

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

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I am not willing to keep my current antidepressant treatment as is.

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I take more than 1 mg/day of lorazepam or its equivalent.

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I have been diagnosed with bipolar disorder (I or II).

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ administered at screening, every other day for 2 weeks in accelerated group, weekly for 6 weeks in once/daily (standard) group, as well as 2-, 4- and 12-weeks post-treatment course for both treatment protocols.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~administered at screening, every other day for 2 weeks in accelerated group, weekly for 6 weeks in once/daily (standard) group, as well as 2-, 4- and 12-weeks post-treatment course for both treatment protocols.

This trial's timeline: 3 weeks for screening, Varies for treatment, and administered at screening, every other day for 2 weeks in accelerated group, weekly for 6 weeks in once/daily (standard) group, as well as 2-, 4- and 12-weeks post-treatment course for both treatment protocols. for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Compare the efficacy of accelerated intermittent theta burst stimulation (iTBS) and standard once daily iTBS on clinical response in adolescents.

Secondary study objectives

Change in self-reported suicidal ideation as measured by Beck Scale for Suicidal Ideation (BSS).

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Active Control

Group I: Accelerated iTBSActive Control1 Intervention

Intermittent Theta Burst Stimulation (iTBS) will be applied to the left dorsolateral prefrontal cortex (DLPFC). Participants will receive daily sessions (Mon-Fri), three times a day for 10 days (2 weeks).

Group II: Standard iTBSActive Control1 Intervention

Intermittent Theta Burst Stimulation (iTBS) will be applied to the left DLPFC. Participants will receive daily sessions (Mon-Fri), once a day for 30 days (6 weeks).

0 / 9Eligibility criteria met