DepressionNCT06580249
Efficacy and Mechanism of rTMS on the Symptoms of Pleasure Deficit in Adolescent Depression
A study testing Repetitive transcranial magnetic stimulation in people with Depression, run by Xijing Hospital at 1 site in China.
Trial summary
(1) Primary objective: to collect data on the score of pleasure deficit scale before and after repetitive transcranial magnetic stimulation treatment in adolescent depressed patients, and to verify its efficacy and safety in adolescent depressed patients in combination with the changes of clinical symptoms; (2)… Read more about this study
- Who is it for?
- Ages 10 to 19 years
- Conditions the study is for
- Depression
- What is being tested?
- Repetitive transcranial magnetic stimulation
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteChina
- Study dates
- 5 Sep 2024to 31 Dec 2025
- 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 10 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age 10-19 years old (both 10 and 19), gender is not limited;
- Meet the criteria for diagnosing MDD in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5);
- First episode or relapse, monophasic or bipolar depressive disorder;
- No history of any form of antidepressant treatment (including medication, physical and psychotherapy) within 2 weeks prior to enrollment;
- Habitual right-handedness;
- Deficit of pleasure scale (DARS) <22 points;
- Score >17 on the 17-item version of the Hamilton Depression Scale (HAMD-17);
- After fully understanding the safety of rTMS, they were willing to actively cooperate with the treatment and signed an informed consent form.
Who cannot join
- Complicated with psychotic symptoms;
- Comorbidity with major psychiatric disorders such as schizophrenia, delusional disorder, delirium, neurocognitive disorder, intellectual disability, and other mental disorders caused by other diseases;
- History of primary neurologic disease or brain injury;
- History of electroconvulsive therapy;
- Contraindications to rTMS treatment, including cardiac pacemakers, neurostimulators, artificial metal heart valves, intracranial aneurysm clips, cochlear implants, and other types of metal implants (with the exception of oral supports);(6)History of epilepsy.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
XijingH
Xi'an, Shaanxi, 710032
Huaning Wang, PhD, xskzhu@fmmu.edu.cn
About this study
Official title: Efficacy and Mechanism of Repetitive Transcranial Magnetic Stimulation on the Symptoms of Pleasure Deficit in Adolescent Depression
(1) Primary objective: to collect data on the score of pleasure deficit scale before and after repetitive transcranial magnetic stimulation treatment in adolescent depressed patients, and to verify its efficacy and safety in adolescent depressed patients in combination with the changes of clinical symptoms; (2) Secondary objective: to explore the relevant hemodynamic mechanisms in adolescent depressed patients before and after repetitive transcranial magnetic stimulation treatment.
Read the detailed description
Depression is one of the most common mental disorders among adolescents and is characterized by persistent low mood. According to a global statistical report released by the World Health Organization, about 350 million people worldwide are affected by depression, with the adolescent population being particularly prominent. Epidemiologic surveys in the Chinese region show that the prevalence of depression in adolescents is about 3.0%. The study points out that age is one of the key factors affecting major depression. Pleasure deficit, a reduced capacity for the experience of pleasure or a lack of appropriate emotional responses to rewards and positive stimuli, is a core symptom of depression and is considered a key internal phenotype of the illness. Repetitive transcranial magnetic stimulation is a treatment for major depressive disorder that delivers a series of equally spaced pulses through repetitive TMS. Studies have shown that rTMS stimulation of the dorsolateral prefrontal cortex can significantly improve symptoms of pleasure deficit. Thus, rTMS may be an effective treatment option for depressed patients with pleasure deficit.
- Conditions
- Depression
- Being tested
- Repetitive transcranial magnetic stimulation
- Keywords
- pleasure deficit, repetitive transcranial magnetic stimulation, adolescent
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repetitive transcranial magnetic stimulationDevice
The true stimulus group acted directly, whereas the pseudo stimulus group reversed the head to produce no effect. Both groups were treated with sertraline medication。
| Study group | Role | What they receive |
|---|---|---|
| Repetitive transcranial magnetic stimulation true stimulation and sertraline treatment | Experimental | The rTMS was administered once a day, implementing approximately 10-20 minutes of physical therapy, with stimulation parameters of 10 Hz frequency, 120% MT intensity, and 50 treatment sequences of 60 stimulations each, with 30-second intervals between the sequences, for a total of 3000 stimulations. For medication: If the depressive episode is only monophasic, give sertraline hydrochloride tablets 1-2 tablets/day for treatment； if the patient has bipolar disorder-depressive episode, give the emotion stabilizer lithium carbonate tablets 0.5-1.0 g/day (adjust the dose according to the blood concentration) for treatment. Receives: Device: Repetitive transcranial magnetic stimulation |
| Sham Repetitive transcranial magnetic stimulation stimulation + sertraline treatment group | Sham comparator | Pseudo stimulation mimicked the tactile and acoustic sensations of rTMS by flipping the head, at 90 degrees to the scalp, with other intervention parameters remaining consistent with the study group. For medication: If the depressive episode is only monophasic, give sertraline hydrochloride tablets 1-2 tablets/day for treatment； if the patient has bipolar disorder-depressive episode, give the emotion stabilizer lithium carbonate tablets 0.5-1.0 g/day (adjust the dose according to the blood concentration) for treatment. Receives: Device: Repetitive transcranial magnetic stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Difference in Scores on the Dimensional Anhedonia Rating Scale (DARS) in Patients from Baseline to 8 Weeks Post-Treatment
The Dimensional Anhedonia Rating Scale, a relatively new tool for assessing symptoms of pleasure deficit, is a self-rating scale. It consists of four sections and 17 questions that focus on the patient's experience of pleasure in the present moment. Each question is rated on a 5-point scale of 1 (never), 2 (occasionally), 3 (sometimes), 4 (often), and 5 (always).The lower the DARS score, the greater the degree of pleasure deficit.
Measured: at baseline, at the end of treatment on day 7, at the end of treatment on day 14, 4 weeks after treatment, and 8 weeks after treatment
Secondary outcomes (4)
Change in Difference in Scores of Patients' HAMD-17 Scores from Baseline to 8 Weeks Post-Treatment
The Hamilton Depression Scale has 17 entries, each of which is categorized into either 5 levels or 3 levels. The scale has a minimum score of zero and a maximum score ranging from 2 to 4 for each rating item. The higher the patient's score, the more severe the depression.
Measured: at baseline, at the end of treatment on day 7, at the end of treatment on day 14, 4 weeks after treatment, and 8 weeks after treatment
Change in Difference in Scores on the Snaith-Hamilton Pleasure Scale (SHAPS) in Patients from Baseline to 8 Weeks Post-Treatment
The Snaith-Hamilton Pleasure Scale has 14 entries, each of which is categorized into 4 levels. The scale has a maximum score of 56 and a minimum score of up to 14. The higher the patient's score, the more severe the pleasure deficit.
Measured: at baseline, at the end of treatment on day 7, at the end of treatment on day 14, 4 weeks after treatment, and 8 weeks after treatment
Change in Difference in Patient Temporal Experience of Pleasure Scale (TEPS) Scores from Baseline to 8 Weeks Post-Treatment
The Temporal Experience of Pleasure Scale has 20 entries, each of which is categorized into 6 levels. The scale has a minimum score of 1 and a maximum score of 6 for each rating item. The lower the patient's score, the more severe the pleasure deficit.
Measured: at baseline, at the end of treatment on day 7, at the end of treatment on day 14, 4 weeks after treatment, and 8 weeks after treatment
functional near-infrared spectroscopy tests were performed from baseline to the end of week 2 of treatment.
Before and after treatment, near-infrared functional brain imaging was performed on each patient to monitor blood oxygen levels in each brain region and ultimately to compare hemodynamic changes before and after treatment.
Measured: at baseline, at the end of treatment on day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2024
- Study start5 Sep 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06580249
- Sponsor's protocol ID
- KY20242219-C-1
- Status last verified
- Sep 2024
- First submitted
- 28 Aug 2024
- Last updated
- 23 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Mechanism of Repetitive Transcranial Magnetic Stimulation on the Symptoms of Pleasure Deficit in Adolescent Depression
- ClinicalTrials.gov ID
- NCT06580249
- Acronym / sponsor ID
- KY20242219-C-1
- Conditions
- Depression
- Keywords
- pleasure deficit, repetitive transcranial magnetic stimulation, adolescent
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 5 Sep 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 30 Aug 2024 (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.
(1) Primary objective: to collect data on the score of pleasure deficit scale before and after repetitive transcranial magnetic stimulation treatment in adolescent depressed patients, and to verify its efficacy and safety in adolescent depressed patients in combination with the changes of clinical symptoms; (2) Secondary objective: to explore the relevant hemodynamic mechanisms in adolescent depressed patients before and after repetitive transcranial magnetic stimulation treatment.
Detailed description
Depression is one of the most common mental disorders among adolescents and is characterized by persistent low mood. According to a global statistical report released by the World Health Organization, about 350 million people worldwide are affected by depression, with the adolescent population being particularly prominent. Epidemiologic surveys in the Chinese region show that the prevalence of depression in adolescents is about 3.0%. The study points out that age is one of the key factors affecting major depression. Pleasure deficit, a reduced capacity for the experience of pleasure or a lack of appropriate emotional responses to rewards and positive stimuli, is a core symptom of depression and is considered a key internal phenotype of the illness. Repetitive transcranial magnetic stimulation is a treatment for major depressive disorder that delivers a series of equally spaced pulses through repetitive TMS. Studies have shown that rTMS stimulation of the dorsolateral prefrontal cortex can significantly improve symptoms of pleasure deficit. Thus, rTMS may be an effective treatment option for depressed patients with pleasure deficit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Repetitive transcranial magnetic stimulation true stimulation and sertraline treatment | Experimental | Device: Repetitive transcranial magnetic stimulationThe rTMS was administered once a day, implementing approximately 10-20 minutes of physical therapy, with stimulation parameters of 10 Hz frequency, 120% MT intensity, and 50 treatment sequences of 60 stimulations each, with 30-second intervals between the sequences, for a total of 3000 stimulations. For medication: If the depressive episode is only monophasic, give sertraline hydrochloride tablets 1-2 tablets/day for treatment； if the patient has bipolar disorder-depressive episode, give the emotion stabilizer lithium carbonate tablets 0.5-1.0 g/day (adjust the dose according to the blood concentration) for treatment. |
| Sham Repetitive transcranial magnetic stimulation stimulation + sertraline treatment group | Sham comparator | Device: Repetitive transcranial magnetic stimulationPseudo stimulation mimicked the tactile and acoustic sensations of rTMS by flipping the head, at 90 degrees to the scalp, with other intervention parameters remaining consistent with the study group. For medication: If the depressive episode is only monophasic, give sertraline hydrochloride tablets 1-2 tablets/day for treatment； if the patient has bipolar disorder-depressive episode, give the emotion stabilizer lithium carbonate tablets 0.5-1.0 g/day (adjust the dose according to the blood concentration) for treatment. |
Who may qualify
- Ages
- 10 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- Age 10-19 years old (both 10 and 19), gender is not limited;
- Meet the criteria for diagnosing MDD in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5);
- First episode or relapse, monophasic or bipolar depressive disorder;
- No history of any form of antidepressant treatment (including medication, physical and psychotherapy) within 2 weeks prior to enrollment;
- Habitual right-handedness;
Key exclusion criteria (5 listed)
- Complicated with psychotic symptoms;
- Comorbidity with major psychiatric disorders such as schizophrenia, delusional disorder, delirium, neurocognitive disorder, intellectual disability, and other mental disorders caused by other diseases;
- History of primary neurologic disease or brain injury;
- History of electroconvulsive therapy;
- Contraindications to rTMS treatment, including cardiac pacemakers, neurostimulators, artificial metal heart valves, intracranial aneurysm clips, cochlear implants, and other types of metal implants (with the exception of oral supports);(6)History of epilepsy.
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 stimulationThe true stimulus group acted directly, whereas the pseudo stimulus group reversed the head to produce no effect. Both groups were treated with sertraline medication。 | Device | Repetitive transcranial magnetic stimulation true stimulation and sertraline treatment, Sham Repetitive transcranial magnetic stimulation stimulation + sertraline treatment group |
Primary outcome
Change in Difference in Scores on the Dimensional Anhedonia Rating Scale (DARS) in Patients from Baseline to 8 Weeks Post-Treatment
Time frame: at baseline, at the end of treatment on day 7, at the end of treatment on day 14, 4 weeks after treatment, and 8 weeks after treatment
The Dimensional Anhedonia Rating Scale, a relatively new tool for assessing symptoms of pleasure deficit, is a self-rating scale. It consists of four sections and 17 questions that focus on the patient's experience of pleasure in the present moment. Each question is rated on a 5-point scale of 1 (never), 2 (occasionally), 3 (sometimes), 4 (often), and 5 (always).The lower the DARS score, the greater the degree of pleasure deficit.
4 secondary outcomes
Change in Difference in Scores of Patients' HAMD-17 Scores from Baseline to 8 Weeks Post-Treatment
Time frame: at baseline, at the end of treatment on day 7, at the end of treatment on day 14, 4 weeks after treatment, and 8 weeks after treatment
Change in Difference in Scores on the Snaith-Hamilton Pleasure Scale (SHAPS) in Patients from Baseline to 8 Weeks Post-Treatment
Time frame: at baseline, at the end of treatment on day 7, at the end of treatment on day 14, 4 weeks after treatment, and 8 weeks after treatment
Change in Difference in Patient Temporal Experience of Pleasure Scale (TEPS) Scores from Baseline to 8 Weeks Post-Treatment
Time frame: at baseline, at the end of treatment on day 7, at the end of treatment on day 14, 4 weeks after treatment, and 8 weeks after treatment
functional near-infrared spectroscopy tests were performed from baseline to the end of week 2 of treatment.
Time frame: at baseline, at the end of treatment on day 14
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Repetitive transcranial magnetic stimulation in people with Depression, 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 8 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 23 Sep 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Siheng Ma (+8613571652479, matthewsiheng@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Difference in Scores on the Dimensional Anhedonia Rating Scale (DARS) in Patients from Baseline to 8 Weeks Post-Treatment (time frame: at baseline, at the end of treatment on day 7, at the end of treatment on day 14, 4 weeks after treatment, and 8 weeks after treatment). 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 23 Sep 2024.