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Major Depressive EpisodePRTMSTMDEAYANCT05465928

Personalized Repetitive Transcranial Magnetic Stimulation Treatment for Major Depressive Episode

A study testing Active rTMS in people with Major Depressive Episode, run by Jiangsu Province Nanjing Brain Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Adolescents and young adults with mood disorders experiencing major depressive episode have poor efficacy of medication treatment. Repetitive magnetic transcranial stimulation (rTMS) has been proven adjuvant efficacy in patients with major depressive episode. Read more about this study

Who is it for?
Ages 13 to 25 years
Conditions the study is for
Major Depressive Episode
What is being tested?
Active rTMS
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
219 participants
Where
1 siteChina
Study dates
2 Aug 2022to 20 Jan 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 13 to 25 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Between 13 and 25 years of age;
  • Participants fulfill the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) diagnostic criteria for major depressive disorder (MDD) or 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 rTMS treatment phase;
  • Participants and 1 or 2 parents (patients' age< 18 years old) provide informed consent after the detailed description of the study.

Who cannot join

  • Prior rTMS 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;
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  • Mental retardation or autism spectrum disorder;
  • Contraindications to MRI (e.g., severe claustrophobia, pacemakers, metal implants);
  • Contraindications to rTMS (e.g., metal in head, history of seizure, electroencephalogram (EEG) test suggesting high risk of seizure, known brain lesion);
  • Current drug/alcohol abuse or dependence;
  • Pregnant or lactating female.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Affiliated Nanjing Brain Hospital, Nanjing Medical University

    Nanjing, Jiangsu, 210000

Other trials in China

About this study

Official title: Neuroimaging Biomarker-Guided Personalized Repetitive Transcranial Magnetic Stimulation (rTMS) Treatment for Major Depressive Episode in Adolescents and Young Adults with Mood Disorders: a Randomized, Double-Blind, Controlled Study

Adolescents and young adults with mood disorders experiencing major depressive episode have poor efficacy of medication treatment. Repetitive magnetic transcranial stimulation (rTMS) has been proven adjuvant efficacy in patients with major depressive episode. However, the optimal evidence-based stimulation parameters have not been clearly defined, which greatly limits the efficacy of rTMS in the treatment of major depressive episode.

This trial will compare a novel form of personalized rTMS treatment protocol guided by neuroimaging biomarkers to the sham stimulation.The personalized selection of stimulation parameters, such as stimulation site, frequency and magnetic pulse number, will be determined by neuroimaging biomarkers.

The study aims to propose a novel personalized neuroimaging-guided rTMS strategy, to evaluate the efficacy and safety of the treatment, further to understand the biological mechanism of the personalized rTMS treatment.

Read the detailed description

Mood disorders, including mainly bipolar disorder (BD) and major depressive disorder (MDD), have become the primary health problem and one of the leading causes of functional disability in adolescents and young adults. In China, the incidence of mood disorders such as BD and MDD in adolescents and young adults has increased rapidly in recent years. Particularly, mood disorder patients currently experiencing major depressive episode are considered to be at high risk for suicide, and pharmacological treatment showed poor efficacy to such depressive patients. Mood disorders with major depressive episode have become one of the main threats to youth mental health in China. Therefore, it is of great significance to explore a series of early intervention strategies for adolescents and young adults with major depressive episode.

rTMS is a non-invasive brain stimulation treatment strategy with mild side effects. In 2008, rTMS was approved by the Food and Drug Administration (FDA) for the treatment of major depression. The selection of stimulation parameters often has a vital impact on the clinical efficacy of rTMS treatment. Several clinical trials have reported the efficacy and safety of rTMS on treatment resistant major depression. However, the evidence-based optimal targets and other stimulation parameters have not been clearly defined, which greatly limits the efficacy of rTMS in the treatment of major depressive episode. To date, there is no large randomized clinical trial (RCT) exploring an optimization of rTMS on adolescents and young adults with major depressive episode.

This study is a double-blind randomized controlled trial aiming at assessing the efficacy and safety of a novel personalized rTMS treatment protocol compared to sham stimulation for major depressive episode in adolescents and young adults with mood disorders. Participants will be assigned randomly (1:1) to the personalized rTMS group or the sham stimulation group. Participants in the rTMS group will be treated with 20 sessions (2 sessions per day) of personalized rTMS treatment, and participants in the sham stimulation group will receive the same scheme of rTMS treatment but with sham coil. The selection of stimulation parameters (stimulation site, frequency, number of pulses, number of sessions, train and inter-train duration) in both groups will be based on neuroimaging biomarkers extracted via machine learning method. Participants in both groups will maintain the stable drug regimen during the rTMS trial.

At baseline and after each 10 sessions of treatment, patients will receive the assessment of depressive symptom severity, cranial magnetic resonance imaging (MRI) scan and peripheral blood collection (about 15ml peripheral blood). Before and after 20 sessions of treatment, neurocognitive function test will be performed. The purposes of the present study are to: 1) evaluate the clinical response to the personalized rTMS treatment by comparing the change in depressive symptom and neurocognitive function over the course of rTMS trial. 2) further understand the possible biological mechanism underlying the efficacy of personalized rTMS treatment by analyzing alterations from multidimensional data of neuroimaging, plasma proteomics and metabolomics.

Being tested
Active rTMS, Sham rTMS
Keywords
Repetitive Transcranial Magnetic Stimulation, Major Depressive Episode, Functional Magnetic Resonance Imaging

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Active rTMSDevice

    Also called VISHEE Magneuro stimulator

    rTMS is a non-invasive neuromodulation therapy which has been recognized as a helpful treatment for depression. During each rTMS treatment, the magnetic field is generated by a coil which is placed on the head near the brain region of interest, and further, an electrical current is induced to modulate brain activity.

  • Sham rTMSDevice

    The sham rTMS stimulation is performed based on a sham coil which will mimic scalp sensations and the acoustic artifact of the active stimulation, without delivering any magnetic pulse.

Study groups in NCT05465928
Study groupRoleWhat they receive
Personalized rTMSExperimentalThe active arm will receive the personalized rTMS treatment with parameters as follows: 1. Neuroimaging biomarker-guided personalized selection for stimulation frequency: low frequency(1HZ) or high frequency (10HZ); 2. Neuroimaging biomarker-guided personalized selection for stimulation site: dorsalmedial prefrontal cortex or occipital cortex; 3. Schedule: 2 sessions per day, five days per week for a total of 20 sessions over 2 weeks.
Receives: Device: Active rTMS
sham stimulation rTMSSham comparatorSham stimulation arm will receive the same scheme of rTMS but with a sham coil.
Receives: Device: Sham rTMS

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline in depressive symptoms assessed by Hamilton depression rating scale 17 items (HAMD-17) at week 1 and week 2.

    The HAMD-17 scale has 17 items. The total score ranges from 0-52, with higher score indicating more severe depressive symptoms. A total score of 0-7 is considered to be normal. Scores of 17 or higher indicate moderate, severe, or very severe depression.

    Measured: Baseline, week 1 and week 2.

  2. Change from baseline in the amplitude of low-frequency fluctuation (ALFF) values measured by resting-state functional magnetic resonance imaging (fMRI) at week 1 and week 2.

    Participants will undergo fMRI scans prior to beginning rTMS treatment (week 0) and after completing 10 sessions of rTMS treatment (weeks 1) and after completing 20 sessions of rTMS treatment (weeks 2). ALFF is a fMRI indicator that reflects the spontaneous neural activity. After data acquisition, whole-brain voxel-wise analysis of ALFF values will be performed to detect the change from baseline in brain functional activity at week 1 and week 2.

    Measured: Baseline, week 1 and week 2.

  3. Change from baseline in neurocognitive function using Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) test at week 2.

    RBANS is a test for identifying and characterizing abnormal cognitive decline for patients with neuropsychiatric disorders. The RBANS is comprised of five domains, which are Immediate Memory, Visuospatial /Constructional, Language, Attention and Delayed Memory. The total score of RBANS range from 40-160, with 160 referring to higher cognitive functioning. A score of 95-115 is in the average range; score of 70-85 mild to moderate cognitive impairment; score <70 moderate to severe impairment.

    Measured: Baseline and week 2.

Secondary outcomes (2)

  1. Change from baseline in the Clinical Global Impression-Severity scale (CGI-S) at week 1 and week 2.

    The CGI-S is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. A rating of 1 is considered normal, or with the least severe symptoms, a rating of 7 is extremely ill, or the worst symptoms.

    Measured: Baseline, week 1 and week 2.

  2. Change from baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) at week 1 and week 2.

    MADRS is a clinician-rated scale used to assess depressive symptom severity and detect changes due to antidepressant treatment. The scale consists of 10 items, each of which is rated from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms). The total score of MADRS ranges from 0 to 60, with higher score indicating more severe depression.

    Measured: Baseline, week 1 and week 2.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jul 2022
  2. Study start2 Aug 2022
  3. Primary completion20 Jan 2024
  4. Study completion20 Jan 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
219 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05465928
Sponsor's protocol ID
81725005-2
Acronym
PRTMSTMDEAYA
Status last verified
Jan 2024
First submitted
22 Jun 2022
Last updated
6 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Kalin NH. Advances in Understanding and Treating Mood Disorders. Am J Psychiatry. 2020 Aug 1;177(8):647-650. doi: 10.1176/appi.ajp.2020.20060877. No abstract available.

    PubMed 32741277

  • Nesvag R, Bramness JG, Handal M, Hartz I, Hjellvik V, Skurtveit S. The incidence, psychiatric co-morbidity and pharmacological treatment of severe mental disorders in children and adolescents. Eur Psychiatry. 2018 Mar;49:16-22. doi: 10.1016/j.eurpsy.2017.12.009. Epub 2018 Feb 3.

    PubMed 29366845

  • Rumi DO, Gattaz WF, Rigonatti SP, Rosa MA, Fregni F, Rosa MO, Mansur C, Myczkowski ML, Moreno RA, Marcolin MA. Transcranial magnetic stimulation accelerates the antidepressant effect of amitriptyline in severe depression: a double-blind placebo-controlled study. Biol Psychiatry. 2005 Jan 15;57(2):162-6. doi: 10.1016/j.biopsych.2004.10.029.

    PubMed 15652875

  • Rosenich E, Gill S, Clarke P, Paterson T, Hahn L, Galletly C. Does rTMS reduce depressive symptoms in young people who have not responded to antidepressants? Early Interv Psychiatry. 2019 Oct;13(5):1129-1135. doi: 10.1111/eip.12743. Epub 2018 Oct 10.

    PubMed 30303308

  • Mayer G, Aviram S, Walter G, Levkovitz Y, Bloch Y. Long-term follow-up of adolescents with resistant depression treated with repetitive transcranial magnetic stimulation. J ECT. 2012 Jun;28(2):84-6. doi: 10.1097/YCT.0b013e318238f01a.

    PubMed 22531199

  • Hett D, Rogers J, Humpston C, Marwaha S. Repetitive Transcranial Magnetic Stimulation (rTMS) for the Treatment of Depression in Adolescence: A Systematic Review. J Affect Disord. 2021 Jan 1;278:460-469. doi: 10.1016/j.jad.2020.09.058. Epub 2020 Sep 15.

    PubMed 33011525

  • Weigand A, Horn A, Caballero R, Cooke D, Stern AP, Taylor SF, Press D, Pascual-Leone A, Fox MD. Prospective Validation That Subgenual Connectivity Predicts Antidepressant Efficacy of Transcranial Magnetic Stimulation Sites. Biol Psychiatry. 2018 Jul 1;84(1):28-37. doi: 10.1016/j.biopsych.2017.10.028. Epub 2017 Nov 10.

    PubMed 29274805

  • Fox MD, Buckner RL, White MP, Greicius MD, Pascual-Leone A. Efficacy of transcranial magnetic stimulation targets for depression is related to intrinsic functional connectivity with the subgenual cingulate. Biol Psychiatry. 2012 Oct 1;72(7):595-603. doi: 10.1016/j.biopsych.2012.04.028. Epub 2012 Jun 1.

    PubMed 22658708

  • Downar J, Geraci J, Salomons TV, Dunlop K, Wheeler S, McAndrews MP, Bakker N, Blumberger DM, Daskalakis ZJ, Kennedy SH, Flint AJ, Giacobbe P. Anhedonia and reward-circuit connectivity distinguish nonresponders from responders to dorsomedial prefrontal repetitive transcranial magnetic stimulation in major depression. Biol Psychiatry. 2014 Aug 1;76(3):176-85. doi: 10.1016/j.biopsych.2013.10.026. Epub 2013 Nov 28.

    PubMed 24388670

  • Chang M, Womer FY, Gong X, Chen X, Tang L, Feng R, Dong S, Duan J, Chen Y, Zhang R, Wang Y, Ren S, Wang Y, Kang J, Yin Z, Wei Y, Wei S, Jiang X, Xu K, Cao B, Zhang Y, Zhang W, Tang Y, Zhang X, Wang F. Identifying and validating subtypes within major psychiatric disorders based on frontal-posterior functional imbalance via deep learning. Mol Psychiatry. 2021 Jul;26(7):2991-3002. doi: 10.1038/s41380-020-00892-3. Epub 2020 Oct 1.

    PubMed 33005028

Questions about this trial

What is this clinical trial studying?

A study testing Active rTMS in people with Major Depressive Episode, run by Jiangsu Province Nanjing Brain Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in depressive symptoms assessed by Hamilton depression rating scale 17 items (HAMD-17) at week 1 and week 2. (time frame: Baseline, week 1 and week 2.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05465928, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2025.

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