Evaluation of Theta-burst Stimulation Efficacy, Safety and Tolerability in Major Depressive Episo… (NCT05501626) | Clinical Trial Compass
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Evaluation of Theta-burst Stimulation Efficacy, Safety and Tolerability in Major Depressive Episodes of Bipolar I Disorder
Brazil60 participantsStarted 2022-07-10
Plain-language summary
INTRODUCTION: Pharmacological treatment of major depressive episodes in bipolar disorder (BD) is characterized by suboptimal efficacy rates, poor tolerability and adherence, delayed onset of action, and iatrogenic mood swings. The use of repetitive transcranial magnetic stimulation (rTMS) has been presented as an effective, safe and well-tolerated alternative to the treatment of uni- and bipolar depressive episodes. Recently, a new rTMS protocol was introduced, theta-burst stimulation (TBS), whose studies have shown similar efficacy with a shorter time interval than conventional rTMS. Most clinical trials performed to date evaluate the use of TBS in patients with unipolar depression or mixed samples of uni and bipolar patients. The effectiveness of TBS exclusively in BD has not been properly studied. METHODS: We will perform a 6-week, double-blind, randomized, parallel-group, sham-controlled clinical trial of active or sham TBS. We will recruit 60 patients aged between 18 and 65 years with a diagnosis of BD type I in a current moderate or severe major depressive episode resistant to at least two first- or second-line pharmacological treatments, according to CANMAT guidelines. The primary outcome measure will be the assessment of TBS efficacy through difference in scores on 17-item Hamilton Depression Scale (HAM-D) from baseline until the end of week 6 of intervention between active and sham groups. KEYWORDS: randomized clinical trial; transcranial magnetic stimulation; bipolar affective disorder; major depression.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Current moderate or severe major depressive episode in bipolar I disorder assessed with Hamilton Depression Rating Scale (HAM-D) score ≥ 17 points.
* Any appropriate first or second line pharmacological regimen in accordance with Canmat guidelines to treat a major depressive episode in bipolar I disorder:
Quetiapine 300 - 600 mg/dia; Lithium serum levels 0,6 - 1,2 meq/L; Lamotrigine 100 - 200 mg/dia; Lurasidone 20 - 120 mg/dia; Divalproex; Lithium/Divalproex + Lurasidone; Lithium/Divalproex + Lamotrigine; Olanzapine 5 - 20 mg/day + Fluoxetine 20 - 60 mg/day; Lithium/Divalproex + SSRI/Bupropion.
Exclusion Criteria:
* Concomitant diagnosis of other neuropsychiatric disorders such as: schizophrenia, dementias, mental retardation, organic mental disorder, or epilepsy;
* Acute suicide ideation (assessed by interview and clinical evaluation);
* Acute psychotic depression (assessed by interview and clinical evaluation);
* Suspected or confirmed pregnancy;
* Women in breastfeeding;
* Severe or unstable clinical disease;
* Previous rTMS treatment;
* Specific contraindications to TBS: previous epileptic seizures; change in electroencephalogram at some point in life; previous stroke; previous severe traumatic brain injury (with neurosurgery); metallic object on head (except mouth) as projectile piece, surgical clip, welding fragments; any implanted device (cardiac pacemaker, intravenous catheter).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.