Major Depressive DisorderNCT05544071
Individualized dlPFC-NAcc Modulation for Anhedonia in adMDD
A study testing Transcranial Magnetic Stimulation (TMS) in people with Major Depressive Disorder and Repetitive Transcranial Magnetic Stimulation, run by Xijing Hospital at 1 site in China.
Trial summary
This study evaluates a schedule of precise repetitive transcranial magnetic stimulation for depressive adolescent with anhedonia. In this randomized controlled trial, half of the participants will receive repetitive transcranial magnetic stimulation, and the other will receive sham stimulation. Read more about this study
- Who is it for?
- Ages 13 to 18 years
- Conditions the study is for
- Major Depressive Disorder, Repetitive Transcranial Magnetic Stimulation
- What is being tested?
- Transcranial Magnetic Stimulation (TMS)
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 88 participants
- Where
- 1 siteChina
- Study dates
- 12 Feb 2023to 31 Jul 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 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Male or female, 13 to 18 years of age.
- According to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Diagnosed with Major Depressive Disorder (MDD) and currently experiencing a Major Depressive Episode (MDE).
- Meet the threshold on the total HAMD17 score of >/=17 at both screening and baseline visits (Day -7 and Day 0).
- Meet the threshold on the total SHAPS score of >/=20 at both screening and baseline visits (Day -7 and Day 0).
- Not take any antidepressants for two or more weeks before screening.
- In good general health, as ascertained by medical history.
- After fully understanding the treatment of transcranial magnetic stimulation, willing to cooperate with the treatment actively and able to provide informed consent.
Who cannot join
- Current diagnosis of a Substance Use Disorder, with the exception of nicotine and caffeine dependence.
- Current diagnosis of mental disorders other than Dysthymic Disorder, Generalized Anxiety Disorder, Social Anxiety Disorder, Panic Disorder, Agoraphobia, or Specific Phobia (unless one of these is clinically unstable, and/or the focus of the participant's treatment for the past six months or more).
- History of schizophrenia or schizoaffective disorders, or any history of psychotic symptoms in the current or previous depressive episodes.
- Any other Mental Disorders, Personality Disorders, Intellectual Disability, which at screening is clinically predominant to their MDD.
- Has a clinically significant abnormality on the screening examination that might affect safety, study participation, or confound interpretation of study results.
- Any current or past history of any physical condition which in the investigator's opinion might put the subject at risk or interfere with study results interpretation.
Show all 14Show fewer
- Participation in any clinical trial with an investigational drug or device within the past month or concurrent to study participation.
- History of electronic instrument or metal in the head or skull.
- History of epilepsy.
- History of cardiovascular disease or cardiac event.
- History of OCD.
- History of autism spectrum disorder.
- History of rTMS exposure.
- Other situations judged by the researchers to be unsuitable for the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Efficacy of rTMS on Individualized dlPFC-NAcc Functional Connectivity in Adolescents With Depression and Anhedonia: a Randomized Clinical Trial
This study evaluates a schedule of precise repetitive transcranial magnetic stimulation for depressive adolescent with anhedonia. In this randomized controlled trial, half of the participants will receive repetitive transcranial magnetic stimulation, and the other will receive sham stimulation.
Read the detailed description
Repetitive transcranial magnetic stimulation (rTMS) is an established technology as therapy for treatment-resistant depression among adult. The approved method for treatment is 10Hz stimulation over the left dorsolateral prefrontal cortex (L-DLPFC). This methodology has been successful for many people with treatment-resistant depression. However, a large percentage of adolescents suffering from major depressive disorder (MDD) do not adequately benefit from currently available treatments. One of the limitations is concerns about the safety and efficacy of antidepressant. Recently, researchers have aggressively pursued better treatment strategy such as rTMS to improve adolescent depression with some preliminary success. This study intends to further explore the safety and efficacy of rTMS in the treatment for adolescent major depressive disorder with anhedonia. This study will also look at the change in neuroimaging biomarkers associated with this treatment.
- Being tested
- Transcranial Magnetic Stimulation (TMS)
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Magnetic Stimulation (TMS)Device
Also called TMS, Sertraline
Compare active coil with sham coil.
| Study group | Role | What they receive |
|---|---|---|
| rTMS Active | Active comparator | Blinded Active TMS coil. Active repetitive Transcranial Magnetic Stimulation (rTMS) and Sertraline (dosage form: pill, dosage: 50mg, frequency and duration: At the beginning of the treatment, the dose of 25mg/ was taken for 1-3 days and adjusted to 50mg/ days for 4-7 days. If there were no dose-limiting adverse events, the dose could be titrated to 100mg/ days in the second week. The dose could be flexibly adjusted within the range of 100~150mg/ days until a satisfactory clinical response was achieved. After that, the drug dose was kept unchanged as far as possible. Take it once a day, after a meal at a relatively fixed time in the morning.) Receives: Device: Transcranial Magnetic Stimulation (TMS) |
| rTMS Sham | Sham comparator | Blinded Sham TMS coil. Sham Transcranial Magnetic Stimulation (TMS) and Sertraline (dosage form: pill, dosage: 50mg, frequency and duration: At the beginning of the treatment, the dose of 25mg/ was taken for 1-3 days and adjusted to 50mg/ days for 4-7 days. If there were no dose-limiting adverse events, the dose could be titrated to 100mg/ days in the second week. The dose could be flexibly adjusted within the range of 100~150mg/ days until a satisfactory clinical response was achieved. After that, the drug dose was kept unchanged as far as possible. Take it once a day, after a meal at a relatively fixed time in the morning.) Receives: Device: Transcranial Magnetic Stimulation (TMS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change in the Snaith-Hamilton Pleasure Scale (SHAPS)Score From Pre-treatment to 8-weeks
A 14 item self-assessment questionnaire used to measure the severity of anhedonia symptom in patients with mood disorders. Scale range - 14 to 56 with higher score indicative of greater anhedonia symptomology.
Measured: Pre-treatment and 8-weeks post treatment
Secondary outcomes (8)
Score of the Hamilton Rating Scale for Depression (HAM-17)
A provider administered questionnaire used to assess remission and recovery from depression. Scale range - 0 to 52 with higher score indicative of greater depressive symptomology. Additional collection time points were prespecified; only those time points for which data were collected are reported.
Measured: Baseline; Day 7; Day 15; Day 28 (Week 4 from baseline); Day 56 (Week 8 from baseline)
Score of the Montgomery Asberg Depression Rating Scale (MADRS)
A diagnostic questionnaire used to measure the severity of depressive symptoms. Scale range - 0 to 60 with higher score indicative of greater depressive symptomology.
Measured: Baseline; Day 7; Day 15; Day 28 (Week 4 from baseline); Day 56 (Week 8 from baseline)
Score of the Chinese version of Temporal Experience of Pleasure Scale(CV-TEPS)
A 20 item self-assessment questionnaire, eleven items used to measure anticipatory anhedonia, and nine items used to evaluate consummatory anhedonia. Scale range - 0 to 140 with lower score indicative of greater anhedonia symptomology.
Measured: Baseline; Day 7; Day 15; Day 28 (Week 4 from baseline); Day 56 (Week 8 from baseline)
Score of the Chinese version of Beck Scale for Suicide Ideation（BSI-CV）
A 19 item questionnaire used to evaluate the severity of suicidal ideation. The scale includes two subscales of suicidal ideation (Current suicidal ideation, BSI-C) and suicidal ideation (Suicidal ideation at one's worst point, BSI-W) in the last week. Scale range - 0 to 38, the higher the score of the subscale, the higher the level of suicidal ideation in the last week or the most serious.
Measured: Baseline; Day 7; Day 15; Day 28 (Week 4 from baseline); Day 56 (Week 8 from baseline)
Score of the Insomnia Severity Index Scale （ISI）
The questionnaire consists of seven items: the severity of insomnia symptoms, the satisfaction of sleep patterns, the effects of insomnia on daytime function, the effects of insomnia on subjects' quality of life, and the degree of worry or depression caused by insomnia. Scale range - 0 to 28 with higher score indicative of greater Insomnia symptomology.
Measured: Baseline; Day 7; Day 15; Day 28 (Week 4 from baseline); Day 56 (Week 8 from baseline)
Score of the Clinical Global Impression (CGI)
The questionnaire used to evaluate the clinical efficacy, it includes three parts: severity of illness (SI), global improvement (GI) and effect index (EI). With higher score indicative of more serious disease and worse effect.
Measured: Baseline; Day 7; Day 15; Day 28 (Week 4 from baseline); Day 56 (Week 8 from baseline)
Score of the Snaith-Hamilton Pleasure Scale (SHAPS)
A 14 item self-assessment questionnaire used to measure the severity of anhedonia symptom in patients with mood disorders. Scale range - 14 to 56 with higher score indicative of greater anhedonia symptomology.
Measured: Baseline; Day 7; Day 15; Day 28 (Week 4 from baseline); Day 56 (Week 8 from baseline)
Change From Baseline Functional Connectivity to 15-days Post-treatment
We will assess change in resting state fMRI functional connectivity of the nucleus accumbens to the Dorsolateral Prefrontal Cortex and within the reward-related circuits
Measured: Time Frame: Pre-treatment, immediately post-treatment (on day 15)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2022
- Study start12 Feb 2023
- Primary completion31 Jul 2024
- Study completion31 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by Xijing HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05544071
- Sponsor's protocol ID
- KY20222165-F-1
- Status last verified
- Sep 2026
- First submitted
- 13 Sep 2022
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zheng K, Zheng X, Shi H, Chen L, Li L; DIRECT consortium; Hu D, Friston KJ, Wang H, Li B, Chen B. Brain contrastive modeling reveals depression subtypes with distinct treatment response and progression. NPJ Digit Med. 2026 Jul 20. doi: 10.1038/s41746-026-03011-8. Online ahead of print.
PubMed 42477489Zheng K, Chen L, Wang H; DIRECT consortium; Li B, Chen B. Beyond depression symptoms: the default mode network as a predictor of antidepressant response. Npj Ment Health Res. 2026 Jan 16;5(1):2. doi: 10.1038/s44184-025-00182-2.
PubMed 41545765Lv R, Cai M, Tang N, Shi Y, Zhang Y, Liu N, Han T, Zhang Y, Wang H. Active versus sham DLPFC-NAc rTMS for depressed adolescents with anhedonia using resting-state functional magnetic resonance imaging (fMRI): a study protocol for a randomized placebo-controlled trial. Trials. 2024 Jan 13;25(1):44. doi: 10.1186/s13063-023-07814-y.
PubMed 38218932
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of rTMS on Individualized dlPFC-NAcc Functional Connectivity in Adolescents With Depression and Anhedonia: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05544071
- Acronym / sponsor ID
- KY20222165-F-1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 12 Feb 2023 (actual)
- Primary completion
- 31 Jul 2024 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 16 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates a schedule of precise repetitive transcranial magnetic stimulation for depressive adolescent with anhedonia. In this randomized controlled trial, half of the participants will receive repetitive transcranial magnetic stimulation, and the other will receive sham stimulation.
Detailed description
Repetitive transcranial magnetic stimulation (rTMS) is an established technology as therapy for treatment-resistant depression among adult. The approved method for treatment is 10Hz stimulation over the left dorsolateral prefrontal cortex (L-DLPFC). This methodology has been successful for many people with treatment-resistant depression. However, a large percentage of adolescents suffering from major depressive disorder (MDD) do not adequately benefit from currently available treatments. One of the limitations is concerns about the safety and efficacy of antidepressant. Recently, researchers have aggressively pursued better treatment strategy such as rTMS to improve adolescent depression with some preliminary success. This study intends to further explore the safety and efficacy of rTMS in the treatment for adolescent major depressive disorder with anhedonia. This study will also look at the change in neuroimaging biomarkers associated with this treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| rTMS Active | Active comparator | Device: Transcranial Magnetic Stimulation (TMS)Blinded Active TMS coil. Active repetitive Transcranial Magnetic Stimulation (rTMS) and Sertraline (dosage form: pill, dosage: 50mg, frequency and duration: At the beginning of the treatment, the dose of 25mg/ was taken for 1-3 days and adjusted to 50mg/ days for 4-7 days. If there were no dose-limiting adverse events, the dose could be titrated to 100mg/ days in the second week. The dose could be flexibly adjusted within the range of 100~150mg/ days until a satisfactory clinical response was achieved. After that, the drug dose was kept unchanged as far as possible. Take it once a day, after a meal at a relatively fixed time in the morning.) |
| rTMS Sham | Sham comparator | Device: Transcranial Magnetic Stimulation (TMS)Blinded Sham TMS coil. Sham Transcranial Magnetic Stimulation (TMS) and Sertraline (dosage form: pill, dosage: 50mg, frequency and duration: At the beginning of the treatment, the dose of 25mg/ was taken for 1-3 days and adjusted to 50mg/ days for 4-7 days. If there were no dose-limiting adverse events, the dose could be titrated to 100mg/ days in the second week. The dose could be flexibly adjusted within the range of 100~150mg/ days until a satisfactory clinical response was achieved. After that, the drug dose was kept unchanged as far as possible. Take it once a day, after a meal at a relatively fixed time in the morning.) |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Male or female, 13 to 18 years of age.
- According to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Diagnosed with Major Depressive Disorder (MDD) and currently experiencing a Major Depressive Episode (MDE).
- Meet the threshold on the total HAMD17 score of >/=17 at both screening and baseline visits (Day -7 and Day 0).
- Meet the threshold on the total SHAPS score of >/=20 at both screening and baseline visits (Day -7 and Day 0).
- Not take any antidepressants for two or more weeks before screening.
Key exclusion criteria (14 listed)
- Current diagnosis of a Substance Use Disorder, with the exception of nicotine and caffeine dependence.
- Current diagnosis of mental disorders other than Dysthymic Disorder, Generalized Anxiety Disorder, Social Anxiety Disorder, Panic Disorder, Agoraphobia, or Specific Phobia (unless one of these is clinically unstable, and/or the focus of the participant's treatment for the past six months or more).
- History of schizophrenia or schizoaffective disorders, or any history of psychotic symptoms in the current or previous depressive episodes.
- Any other Mental Disorders, Personality Disorders, Intellectual Disability, which at screening is clinically predominant to their MDD.
- Has a clinically significant abnormality on the screening examination that might affect safety, study participation, or confound interpretation of study results.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial Magnetic Stimulation (TMS)Also: TMS, SertralineCompare active coil with sham coil. | Device | rTMS Active, rTMS Sham |
Primary outcome
Percent Change in the Snaith-Hamilton Pleasure Scale (SHAPS)Score From Pre-treatment to 8-weeks
Time frame: Pre-treatment and 8-weeks post treatment
A 14 item self-assessment questionnaire used to measure the severity of anhedonia symptom in patients with mood disorders. Scale range - 14 to 56 with higher score indicative of greater anhedonia symptomology.
8 secondary outcomes
Score of the Hamilton Rating Scale for Depression (HAM-17)
Time frame: Baseline; Day 7; Day 15; Day 28 (Week 4 from baseline); Day 56 (Week 8 from baseline)
Score of the Montgomery Asberg Depression Rating Scale (MADRS)
Time frame: Baseline; Day 7; Day 15; Day 28 (Week 4 from baseline); Day 56 (Week 8 from baseline)
Score of the Chinese version of Temporal Experience of Pleasure Scale(CV-TEPS)
Time frame: Baseline; Day 7; Day 15; Day 28 (Week 4 from baseline); Day 56 (Week 8 from baseline)
Score of the Chinese version of Beck Scale for Suicide Ideation（BSI-CV）
Time frame: Baseline; Day 7; Day 15; Day 28 (Week 4 from baseline); Day 56 (Week 8 from baseline)
Score of the Insomnia Severity Index Scale （ISI）
Time frame: Baseline; Day 7; Day 15; Day 28 (Week 4 from baseline); Day 56 (Week 8 from baseline)
Score of the Clinical Global Impression (CGI)
Time frame: Baseline; Day 7; Day 15; Day 28 (Week 4 from baseline); Day 56 (Week 8 from baseline)
Score of the Snaith-Hamilton Pleasure Scale (SHAPS)
Time frame: Baseline; Day 7; Day 15; Day 28 (Week 4 from baseline); Day 56 (Week 8 from baseline)
Change From Baseline Functional Connectivity to 15-days Post-treatment
Time frame: Time Frame: Pre-treatment, immediately post-treatment (on day 15)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Derived from this study: PubMed 42477489Zheng K, Zheng X, Shi H, Chen L, Li L; DIRECT consortium; Hu D, Friston KJ, Wang H, Li B, Chen B. Brain contrastive modeling reveals depression subtypes with distinct treatment response and progression. NPJ Digit Med. 2026 Jul 20. doi: 10.1038/s41746-026-03011-8. Online ahead of print.
- Derived from this study: PubMed 41545765Zheng K, Chen L, Wang H; DIRECT consortium; Li B, Chen B. Beyond depression symptoms: the default mode network as a predictor of antidepressant response. Npj Ment Health Res. 2026 Jan 16;5(1):2. doi: 10.1038/s44184-025-00182-2.
- Derived from this study: PubMed 38218932Lv R, Cai M, Tang N, Shi Y, Zhang Y, Liu N, Han T, Zhang Y, Wang H. Active versus sham DLPFC-NAc rTMS for depressed adolescents with anhedonia using resting-state functional magnetic resonance imaging (fMRI): a study protocol for a randomized placebo-controlled trial. Trials. 2024 Jan 13;25(1):44. doi: 10.1186/s13063-023-07814-y.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial Magnetic Stimulation (TMS) in people with Major Depressive Disorder and Repetitive Transcranial Magnetic Stimulation, run by Xijing 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 7 inclusion and 14 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 21 Sep 2026. 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?
Percent Change in the Snaith-Hamilton Pleasure Scale (SHAPS)Score From Pre-treatment to 8-weeks (time frame: Pre-treatment and 8-weeks post treatment). 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 NCT05544071, which also lists 3 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 21 Sep 2026.