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Compares treatment options for Depression
Official title Comparing the Efficacy of Accelerated vs. Standard fMRI-guided iTBS in Treating Adolescents Depression
ClinicalTrials.gov ID: NCT06528938
What this study is testing
- What it's testing
- Repetitive transcranial magnetic stimulation (rTMS) is a Health Canada approved treatment for major depression. Theta burst stimulation (TBS), a type of rTMS, is a very promising new treatment for major depression in adults and adolescents.
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 16 to 19
You may be able to join if
- Voluntary and competent to consent.
- Ages 16-19 years old.
- Can speak and read English.
- Primary and/or predominant diagnosis of major depressive episode without psychotic features in the current episode, confirmed by The Mini...
- Depressive symptoms have not improved after ≥ 1 adequate dose of antidepressant in the current depressive episode.
You likely can't join if
- Diagnosis of bipolar I or II disorder, based on the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria.
- Current or past substance (\< 3 months) (excluding caffeine or nicotine) or alcohol abuse/dependence, as defined in the DSM-5 criteria. Based on...
- Current use of illegal substances or cannabis confirmed by urine screening test.
- Concomitant unstable major medical or neurological disease (e.g., uncontrolled diabetes or renal dysfunction).
- Organic cause of depressive symptoms (e.g. thyroid dysfunction), ruled out by the treating physician.
- Acute suicidality or life-threatening due to self-neglect.
See the full eligibility criteria
- Voluntary and competent to consent.
- Ages 16-19 years old.
- Can speak and read English.
- Primary and/or predominant diagnosis of major depressive episode without psychotic features in the current episode, confirmed by The Mini International Neuropsychiatric Interview for Children and Adolescents (MINI-KID).
- Depressive symptoms have not improved after ≥ 1 adequate dose of antidepressant in the current depressive episode.
- Moderate symptoms in the current depressive episode, indexed by a score of at least 40 on the Children's Depression Rating Scale Revised for depression (CDRS-R).
- Are able to adhere to the treatment schedule.
- Have stable psychotropic medications and/or psychotherapy regimen for at least four weeks before participating in the trial.
- Diagnosis of bipolar I or II disorder, based on the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria.
- Current or past substance (\< 3 months) (excluding caffeine or nicotine) or alcohol abuse/dependence, as defined in the DSM-5 criteria. Based on DSM-5 criteria, mild cannabis or alcohol use would be allowed in the past...
- Current use of illegal substances or cannabis confirmed by urine screening test.
- Concomitant unstable major medical or neurological disease (e.g., uncontrolled diabetes or renal dysfunction).
- Organic cause of depressive symptoms (e.g. thyroid dysfunction), ruled out by the treating physician.
- Acute suicidality or life-threatening due to self-neglect.
- Are pregnant or breastfeeding, or plan to become pregnant during treatment (pregnancy will be assessed by a urine test).
- Have a specific contraindication to TMS and/or MRI (e.g., personal history of epilepsy or seizures, metal head implant, pacemaker).
- Unwilling to maintain the current antidepressant regimen.
- Taking more than 1 mg/day of lorazepam or equivalent.
- Any other condition that, in the opinion of the investigators, would impair the participant's ability to complete the study.
The study team makes the final eligibility decision.
Where it's taking place
- Ottawa, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 16 years to 19 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ottawa, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.