CompletedNot Applicable

RTMS Feasibility Study on Adolescent Depression Stimulation

Sweden20 participantsStarted 2022-01-01

Plain-language summary

This is an open-label study, in which all participants receives an active treatment with repetitive transcranial magnetic stimulation (rTMS) according to clinical protocol. The aim with this pilotstudy is to investigate the feasibility to perform a trial of low-frequency rTMS on treatment-resistant depression in adolescents. The study includes adolescents 13-19 years old, with average to severe depression.

Who can participate

Age range

13 Years – 19 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: * Informed consent from parents and legal guardian * Age 13-19 years * Diagnosis of uni- or bipolar depression verified through a Mini International Neuropsychiatric Interview for children and adolescents (MINI-KID) * Treatment with at least two SSRIs at an adequate dose for at least 8 weeks Exclusion Criteria: * Epilepsy or medical history of seizures * Conductive ferromagnetic or other magnetic sensitive metals implanted in the head or within 30 cm of the treatment coil * Implanted device that is activated or controlled in any way by physiological signals * Implanted medication pumps * Intracardiac lines (even if removed) * Active substance use disorder * Treatment with any medication that could lower the threshold for seizures * Usage of benzodiazepines both as prescribed drug and illegal use * Any condition that seriously increases the risk of non-compliance or loss of follow-up

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.

What they're measuring

Inclusion rate -

Timeframe: two years

Attrition rate

Timeframe: two years

Trial details

NCT IDNCT06126198

SponsorUppsala University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-12-31

View on ClinicalTrials.gov More Major Depressive Disorder trials