Major Depressive Disorder (MDD)NCT07283419
Predictors of rTMS and Group Therapy Efficacy in Adolescent Depression
An observational study of Major Depressive Disorder (MDD) and Adolescent Depression, run by The First Hospital of Hebei Medical University at 1 site in China.
Trial summary
This study aims to identify baseline predictors of treatment efficacy in adolescents with Major Depressive Disorder (MDD) undergoing a combined intervention of repetitive transcranial magnetic stimulation (rTMS) and group therapy. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Major Depressive Disorder (MDD), Adolescent Depression
- What is being tested?
- Repetitive Transcranial Magnetic Stimulation (rTMS) and Group Cognitive Behavioral Therapy (CBT)
- Type of treatment
- Medical device, Lifestyle or therapy programme
- How many people
- 163 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2023to 31 Jul 2024
- Phase
- Observational
- 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 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Inpatients aged 12 to 18 years recruited from the Department of Mental Health at The First Hospital of Hebei Medical University between August 2023 and July 2024. All participants had a primary diagnosis of Major Depressive Disorder (MDD) according to ICD-10 criteria and received a standardized combined intervention of rTMS and group therapy.
Who may be able to join
- Primary diagnosis of Major Depressive Disorder (MDD) according to ICD-10 criteria.
- Score of ≥ 20 on the 24-item Hamilton Depression Rating Scale (HAMD-24).
- Sufficient intellectual and linguistic ability to complete assessments and participate in therapy.
- Provided written informed consent (participants and guardians).
Who cannot join
- Lifetime diagnosis of a psychotic or bipolar disorder.
- Current substance use disorder.
- Significant neurological illness (e.g., epilepsy) or metallic implants contraindicated for rTMS.
- Receiving concurrent formal psychotherapy outside the study protocol.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050000
About this study
Official title: Family Environment and Cognitive Function as Predictors of Efficacy for rTMS Combined With Group Therapy in Adolescent Depression: A Prospective Cohort Study
This study aims to identify baseline predictors of treatment efficacy in adolescents with Major Depressive Disorder (MDD) undergoing a combined intervention of repetitive transcranial magnetic stimulation (rTMS) and group therapy. Specifically, the study investigates the predictive value of family environment characteristics (cohesion, conflict, expressiveness) and cognitive functions (executive function, attention/inhibition).
Read the detailed description
Adolescent depression is a significant health concern, and while combined therapies involving neuromodulation and psychotherapy show promise, individual treatment responses vary heterogeneity. This prospective cohort study enrolled 163 adolescents aged 12-18 with MDD. All participants received a standardized 4-week intervention consisting of 20 sessions of high-frequency (10 Hz) rTMS over the left dorsolateral prefrontal cortex (DLPFC) and 8 sessions of group Cognitive Behavioral Therapy (CBT).
Baseline assessments included the Family Environment Scale (FES) and a neuropsychological battery including the Stroop Color-Word Test and Wisconsin Card Sorting Test (WCST). The primary outcome was the percentage reduction in depressive symptoms measured by the HAMD-24 scale. The study employs multiple linear regression to determine which baseline factors independently predict superior treatment outcomes.
- Being tested
- Repetitive Transcranial Magnetic Stimulation (rTMS), Group Cognitive Behavioral Therapy (CBT)
- 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.
Repetitive Transcranial Magnetic Stimulation (rTMS)Device
High-frequency (10 Hz) rTMS applied over the left dorsolateral prefrontal cortex (DLPFC), administered 5 days per week for 4 weeks (20 sessions total).
Group Cognitive Behavioral Therapy (CBT)Behavioural
Manualized group therapy sessions focused on psychoeducation, cognitive restructuring, emotion regulation, and interpersonal skills, held twice weekly for 4 weeks (8 sessions total).
| Study group | Role | What they receive |
|---|---|---|
| rTMS + Group Therapy Cohort | Adolescents diagnosed with MDD who received the standardized combined intervention. Receives: Device: Repetitive Transcranial Magnetic Stimulation (rTMS); Behavioral: Group Cognitive Behavioral Therapy (CBT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage Reduction in HAMD-24 Score
Treatment efficacy is defined as the percentage reduction in the 24-item Hamilton Depression Rating Scale (HAMD-24) score from baseline to the end of treatment. The formula used is: [(HAMD-24 at Baseline - HAMD-24 at Week 4) / HAMD-24 at Baseline] × 100%. The HAMD-24 assesses the severity of depressive symptoms, with higher scores indicating more severe depression.
Measured: Baseline and Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2025
- Study start1 Aug 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.
- Other trials for Major Depressive Disorder (MDD)Studies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 163 participants (actual)
Sponsor and investigators
- Lead sponsor
- The First Hospital of Hebei Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanju Liu, The First Hospital of Hebei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07283419
- Sponsor's protocol ID
- 2023S00133
- Status last verified
- Dec 2025
- First submitted
- 2 Dec 2025
- Last updated
- 15 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Family Environment and Cognitive Function as Predictors of Efficacy for rTMS Combined With Group Therapy in Adolescent Depression: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT07283419
- Acronym / sponsor ID
- 2023S00133
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 163 participants (actual)
- Lead sponsor
- The First Hospital of Hebei Medical UniversityUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 31 Jul 2024 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 15 Dec 2025 (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 aims to identify baseline predictors of treatment efficacy in adolescents with Major Depressive Disorder (MDD) undergoing a combined intervention of repetitive transcranial magnetic stimulation (rTMS) and group therapy. Specifically, the study investigates the predictive value of family environment characteristics (cohesion, conflict, expressiveness) and cognitive functions (executive function, attention/inhibition).
Detailed description
Adolescent depression is a significant health concern, and while combined therapies involving neuromodulation and psychotherapy show promise, individual treatment responses vary heterogeneity. This prospective cohort study enrolled 163 adolescents aged 12-18 with MDD. All participants received a standardized 4-week intervention consisting of 20 sessions of high-frequency (10 Hz) rTMS over the left dorsolateral prefrontal cortex (DLPFC) and 8 sessions of group Cognitive Behavioral Therapy (CBT).
Baseline assessments included the Family Environment Scale (FES) and a neuropsychological battery including the Stroop Color-Word Test and Wisconsin Card Sorting Test (WCST). The primary outcome was the percentage reduction in depressive symptoms measured by the HAMD-24 scale. The study employs multiple linear regression to determine which baseline factors independently predict superior treatment outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| rTMS + Group Therapy Cohort | – | Device: Repetitive Transcranial Magnetic Stimulation (rTMS), Behavioral: Group Cognitive Behavioral Therapy (CBT)Adolescents diagnosed with MDD who received the standardized combined intervention. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Inpatients aged 12 to 18 years recruited from the Department of Mental Health at The First Hospital of Hebei Medical University between August 2023 and July 2024. All participants had a primary diagnosis of Major Depressive Disorder (MDD) according to ICD-10 criteria and received a standardized combined intervention of rTMS and group therapy.
Key inclusion criteria (4 listed)
- Primary diagnosis of Major Depressive Disorder (MDD) according to ICD-10 criteria.
- Score of ≥ 20 on the 24-item Hamilton Depression Rating Scale (HAMD-24).
- Sufficient intellectual and linguistic ability to complete assessments and participate in therapy.
- Provided written informed consent (participants and guardians).
Key exclusion criteria (4 listed)
- Lifetime diagnosis of a psychotic or bipolar disorder.
- Current substance use disorder.
- Significant neurological illness (e.g., epilepsy) or metallic implants contraindicated for rTMS.
- Receiving concurrent formal psychotherapy outside the study protocol.
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 |
|---|---|---|
| Repetitive Transcranial Magnetic Stimulation (rTMS)High-frequency (10 Hz) rTMS applied over the left dorsolateral prefrontal cortex (DLPFC), administered 5 days per week for 4 weeks (20 sessions total). | Device | rTMS + Group Therapy Cohort |
| Group Cognitive Behavioral Therapy (CBT)Manualized group therapy sessions focused on psychoeducation, cognitive restructuring, emotion regulation, and interpersonal skills, held twice weekly for 4 weeks (8 sessions total). | Behavioural | rTMS + Group Therapy Cohort |
Primary outcome
Percentage Reduction in HAMD-24 Score
Time frame: Baseline and Week 4
Treatment efficacy is defined as the percentage reduction in the 24-item Hamilton Depression Rating Scale (HAMD-24) score from baseline to the end of treatment. The formula used is: [(HAMD-24 at Baseline - HAMD-24 at Week 4) / HAMD-24 at Baseline] × 100%. The HAMD-24 assesses the severity of depressive symptoms, with higher scores indicating more severe depression.
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 15 Dec 2025.
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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?
An observational study of Major Depressive Disorder (MDD) and Adolescent Depression, run by The First Hospital of Hebei Medical University 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 4 inclusion and 4 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 15 Dec 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. 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?
Percentage Reduction in HAMD-24 Score (time frame: Baseline and Week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Dec 2025.