CompletedNot Applicable

Neuronavigation rTMS to Improve Depressive Episodes of Bipolar Disorder in Adolescent

China40 participantsStarted 2022-09-01

Plain-language summary

The purpose of this study is to explore a new stimulation target and protocol for the treatment of depressive episode in adolescents with bipolar disorder through the repetitive transcranial magnetic stimulation(rTMS) under neuronavigation, and verify whether there is abnormal functional connectivity between the emotion-related brain area orbital frontal lobe (OFC) and the primary visual cortex(V1) during the depressive episode, which will contribute to further understand the relevant neural pathway and mechanism.

Who can participate

Age range

14 Years – 28 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

. Age 14-28 years old, regardless of gender;
. Meet DSM-V diagnostic criteria for bipolar depressive episodes;
. Young Mania Rating Scale (YMRS) ≤ 6 points;
. MARDS:12-30 points.
. Han nationality, right-handed;
. More than 9 years of education.

Exclusion criteria

. History of severe somatic or brain organic diseases and craniocerebral trauma;

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

Montgomery-Asberg Depression Rating Scale（MADRS）

Timeframe: 0-8 weeks

Trial details

NCT IDNCT05929183

SponsorFirst Affiliated Hospital of Zhejiang University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-06-30

View on ClinicalTrials.gov More Bipolar Disorder trials