Could a zappy headband lift teen bipolar depression?
NCT ID NCT07246044
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests a gentle, non-invasive brain stimulation method called HD-tDCS in 100 teenagers with bipolar depression. Half get real stimulation, half get a fake version, and both continue their usual medications. Researchers will check if depression scores improve after two weeks and look at brain scans and other data to understand how it works.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- High-definition transcranial direct current stimulation (HD-tDCS)
- What this could lead to
- If it works, this could offer a non-drug option to ease depression symptoms in teenagers with bipolar disorder.
- What could go wrong
- This is an early-stage trial with no phase, so results are uncertain. The sham group may also improve, and benefits might be small or temporary.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 100 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2025
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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12 to 18 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Between 12 and 18 years of age; * Participants fulfill the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) diagnostic criteria for bipolar disorder (BD). Participants are assessed by the Structured Clinical Interview for DSM-IV for Axis I Disorders (SCID-I, patients' age ≥18 years old), or the Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime version (K- SADS-PL, patients' age\< 18 years old); * A current moderate or severe depressive episode defined by HAMD≥17 and Young Mania Rating Scale (YMRS) \<12; * Participants receive a stable psychotropic medication regimen prior to randomization to the trial and are willing to remain on the stable regimen during the HD-tDCS treatment phase; * Participants and 1 or 2 parents (patients' age\< 18 years old) provide informed consent after the detailed description of the study. Exclusion Criteria: * Prior rTMS or tDCS or electroconvulsive therapy (ECT) treatment or standard psychological therapy within 6 months prior to screening; * Comorbidity of other DSM-IV axis I disorders or personality disorders; * Judged clinically to be at serious suicidal risk; * Diabetes mellitus, hypertension, vascular and infectious diseases and other major medical comorbidities; * Unstable medical conditions, e.g., severe asthma; * Neurological disorders, e.g., history of head injury with loss of consciousness for ≥ five minutes, cerebrovascular diseases, brain tumors and neurodegenerative diseases; * Mental retardation or autism spectrum disorder; * Contraindications to MRI (e.g., severe claustrophobia, pacemakers, metal implants); * Contraindications to tDCS (e.g., metal in head, history of seizure, EEG test suggesting high risk of seizure, known brain lesion); * Current drug/alcohol abuse or dependence; * Pregnant or lactating female.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Affiliated Nanjing Brain Hospital, Nanjing Medical University
RECRUITINGNanjing, Jiangsu, 210000, China
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