Treatment Resistant Depression (TRD)NCT06881030
Comparison of Different Acceleration Modes of Transcranial Magnetic Stimulation
A study testing Noninvasive transcranial magnetic stimulation was administered six times daily and Noninvasive transcranial magnetic stimulation was administered 10 times daily in people with Treatment Resistant Depression (TRD), run by First Affiliated Hospital of Zhejiang University.
Trial summary
To compare the efficacy and safety of 6 times a day, 10 times a day acceleration mode and sham stimulation intervention for TRD, and to explore the antidepressant mechanism of accelerated mode, so as to provide a more simple and effective rapid treatment plan for TRD patients. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Treatment Resistant Depression (TRD)
- What is being tested?
- Noninvasive transcranial magnetic stimulation was administered six times daily and Noninvasive transcranial magnetic stimulation was administered 10 times daily
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- 25 Mar 2025to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- The current episode met the DSM-5 diagnostic criteria for major depression, without psychotic symptoms of the first or recurrent drug-free depressive subjects
- After a full course of treatment with two or more antidepressants, the patient had no response, and the level of treatment resistance was moderate to severe as assessed by the Maudsley staging method
- 3.24-item Hamilton depression Scale score ≥20
- 4.The age ranged from 18 to 45 years, both sexes
- 5.Right handed
- 6.Written informed consent was obtained and patients volunteered to participate in the study and be evaluated.
Who cannot join
- 1. Comorbidity with other mental disorders, including schizophrenia, mental retardation, substance dependence, etc.
- 2. Suffering from serious or unstable physical diseases
- 3, pregnant, lactating women, women of childbearing age screening period urine HCG test results are positive
- 4. Subjects with metal objects in the body or other contraindications to MRI scanning
- 5. There are other conditions considered by the investigator to be inappropriate for participation in the clinical trial.
About this study
Official title: Comparison of the Efficacy of Different Modes of Accelerated Transcranial Magnetic Stimulation in Treatment-resistant Depression
To compare the efficacy and safety of 6 times a day, 10 times a day acceleration mode and sham stimulation intervention for TRD, and to explore the antidepressant mechanism of accelerated mode, so as to provide a more simple and effective rapid treatment plan for TRD patients.
- Conditions
- Treatment Resistant Depression (TRD)
- Being tested
- Noninvasive transcranial magnetic stimulation was administered six times daily, Noninvasive transcranial magnetic stimulation was administered 10 times daily, Sham
- Medical subject headings
- Depressive Disorder, Treatment-Resistant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Noninvasive transcranial magnetic stimulation was administered six times dailyProcedure or surgery
The motor threshold of 100% intensity, a TBS stimulus train for 2 seconds, including 10 times of 3 intrapascicular stimulation at 50 Hz and interapascicular stimulation at 5HZ, intervals of 10s, 60 repetitions, that is, a total of 1800 pulses per treatment, 6 treatments per day, 50 min apart, a total of 10800 pulses/day, continuous stimulation for 5 days.
Noninvasive transcranial magnetic stimulation was administered 10 times dailyProcedure or surgery
The motor threshold of 100% intensity, a TBS stimulus train stimulation for 2 seconds, including 10 times of 3 intrapascicular stimulation at 50 Hz and interapascicular stimulation at 5HZ, intervals of 10s, 60 repetitions, that is, a total of 1800 pulses per treatment, 10 treatments per day, intervals of 50 min, a total of 18000 pulses/day, continuous stimulation for 5 days.
ShamProcedure or surgery
The appearance of the sham stimulation coil was consistent with that of the real stimulation coil, which could simulate the touch and sound of the scalp caused by the real stimulation. The treatment frequency, location, intensity and time of the sham stimulation group were the same as those of the real stimulation group.
| Study group | Role | What they receive |
|---|---|---|
| HL intervention group | Active comparator | The motor threshold of 100% intensity, a TBS stimulus train stimulation for 2 seconds, including 10 times of 3 intrapascicular stimulation at 50 Hz and interapascicular stimulation at 5HZ, intervals of 10s, 60 repetitions, that is, a total of 1800 pulses per treatment, 10 treatments per day, intervals of 50 min, a total of 18000 pulses/day, continuous stimulation for 5 days. Receives: Procedure: Noninvasive transcranial magnetic stimulation was administered 10 times daily |
| TT intervention group | Experimental | The motor threshold of 100% intensity, a TBS stimulus train for 2 seconds, including 10 times of 3 intrapascicular stimulation at 50 Hz and interapascicular stimulation at 5HZ, intervals of 10s, 60 repetitions, that is, a total of 1800 pulses per treatment, 6 treatments per day, 50 min apart, a total of 10800 pulses/day, continuous stimulation for 5 days. Receives: Procedure: Noninvasive transcranial magnetic stimulation was administered six times daily |
| sham group | Sham comparator | The appearance of the sham stimulation coil was consistent with that of the real stimulation coil, which could simulate the touch and sound of the scalp caused by the real stimulation. The treatment frequency, location, intensity and time of the sham stimulation group were the same as those of the real stimulation group. Receives: Procedure: Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hamilton Depression Scale (24-items) Total Score Change
The Hamilton Depression Scale (24-items), is a 24 item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders. It's considered the gold standard for rating depression severity and used frequently in clinical trials. Higher HAM-D24 score indicates more severe depression, and each item yields a score of 0 to 4. Remission is defined as HAM-D24 ≤8. A reduction of 50% or more in total score from Baseline indicates clinical response.
Measured: Baseline to end of stimulation period, an average of 5 days
Secondary outcomes (1)
Change in the rate of Hamilton Anxiety Scale score
Hamilton Anxiety Scale is a 17 item diagnostic questionnaire used to measure the severity of anxiety episodes in patients. Each item on the scale is rated on a 5-point scale from 0 (not present) to 4 (severe), with the total score ranging from 0 to 68. The HAMA-17 is often used in clinical and research settings to assess the severity of anxiety symptoms and to evaluate the effectiveness of treatments for anxiety. It is a more comprehensive version of the HAMA that includes additional items to capture a broader range of anxiety symptoms.
Measured: Time Frame: Baseline to end of stimulation period, an average of 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2025
- Study start25 Mar 2025 (estimated)
- Primary completion31 Aug 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 Treatment Resistant Depression (TRD)Studies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Zhejiang UniversityThe 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06881030
- Sponsor's protocol ID
- [2025C]IIT. No. 026
- Status last verified
- Mar 2025
- First submitted
- 10 Mar 2025
- Last updated
- 18 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficacy of Different Modes of Accelerated Transcranial Magnetic Stimulation in Treatment-resistant Depression
- ClinicalTrials.gov ID
- NCT06881030
- Acronym / sponsor ID
- [2025C]IIT. No. 026
- Conditions
- Treatment Resistant Depression (TRD)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Zhejiang UniversityUniversity, hospital or other
- Study start
- 25 Mar 2025 (estimated)
- Primary completion
- 31 Aug 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 18 Mar 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.
To compare the efficacy and safety of 6 times a day, 10 times a day acceleration mode and sham stimulation intervention for TRD, and to explore the antidepressant mechanism of accelerated mode, so as to provide a more simple and effective rapid treatment plan for TRD patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HL intervention group | Active comparator | Procedure: Noninvasive transcranial magnetic stimulation was administered 10 times dailyThe motor threshold of 100% intensity, a TBS stimulus train stimulation for 2 seconds, including 10 times of 3 intrapascicular stimulation at 50 Hz and interapascicular stimulation at 5HZ, intervals of 10s, 60 repetitions, that is, a total of 1800 pulses per treatment, 10 treatments per day, intervals of 50 min, a total of 18000 pulses/day, continuous stimulation for 5 days. |
| TT intervention group | Experimental | Procedure: Noninvasive transcranial magnetic stimulation was administered six times dailyThe motor threshold of 100% intensity, a TBS stimulus train for 2 seconds, including 10 times of 3 intrapascicular stimulation at 50 Hz and interapascicular stimulation at 5HZ, intervals of 10s, 60 repetitions, that is, a total of 1800 pulses per treatment, 6 treatments per day, 50 min apart, a total of 10800 pulses/day, continuous stimulation for 5 days. |
| sham group | Sham comparator | Procedure: ShamThe appearance of the sham stimulation coil was consistent with that of the real stimulation coil, which could simulate the touch and sound of the scalp caused by the real stimulation. The treatment frequency, location, intensity and time of the sham stimulation group were the same as those of the real stimulation group. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- The current episode met the DSM-5 diagnostic criteria for major depression, without psychotic symptoms of the first or recurrent drug-free depressive subjects
- After a full course of treatment with two or more antidepressants, the patient had no response, and the level of treatment resistance was moderate to severe as assessed by the Maudsley staging method
- 3.24-item Hamilton depression Scale score ≥20
- 4.The age ranged from 18 to 45 years, both sexes
- 5.Right handed
Key exclusion criteria (5 listed)
- 1. Comorbidity with other mental disorders, including schizophrenia, mental retardation, substance dependence, etc.
- 2. Suffering from serious or unstable physical diseases
- 3, pregnant, lactating women, women of childbearing age screening period urine HCG test results are positive
- 4. Subjects with metal objects in the body or other contraindications to MRI scanning
- 5. There are other conditions considered by the investigator to be inappropriate for participation in the clinical trial.
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 |
|---|---|---|
| Noninvasive transcranial magnetic stimulation was administered six times dailyThe motor threshold of 100% intensity, a TBS stimulus train for 2 seconds, including 10 times of 3 intrapascicular stimulation at 50 Hz and interapascicular stimulation at 5HZ, intervals of 10s, 60 repetitions, that is, a total of 1800 pulses per treatment, 6 treatments per day, 50 min apart, a total of 10800 pulses/day, continuous stimulation for 5 days. | Procedure or surgery | TT intervention group |
| Noninvasive transcranial magnetic stimulation was administered 10 times dailyThe motor threshold of 100% intensity, a TBS stimulus train stimulation for 2 seconds, including 10 times of 3 intrapascicular stimulation at 50 Hz and interapascicular stimulation at 5HZ, intervals of 10s, 60 repetitions, that is, a total of 1800 pulses per treatment, 10 treatments per day, intervals of 50 min, a total of 18000 pulses/day, continuous stimulation for 5 days. | Procedure or surgery | HL intervention group |
| ShamThe appearance of the sham stimulation coil was consistent with that of the real stimulation coil, which could simulate the touch and sound of the scalp caused by the real stimulation. The treatment frequency, location, intensity and time of the sham stimulation group were the same as those of the real stimulation group. | Procedure or surgery | sham group |
Primary outcome
Hamilton Depression Scale (24-items) Total Score Change
Time frame: Baseline to end of stimulation period, an average of 5 days
The Hamilton Depression Scale (24-items), is a 24 item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders. It's considered the gold standard for rating depression severity and used frequently in clinical trials. Higher HAM-D24 score indicates more severe depression, and each item yields a score of 0 to 4. Remission is defined as HAM-D24 ≤8. A reduction of 50% or more in total score from Baseline indicates clinical response.
1 secondary outcome
Change in the rate of Hamilton Anxiety Scale score
Time frame: Time Frame: Baseline to end of stimulation period, an average of 5 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2025.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Noninvasive transcranial magnetic stimulation was administered six times daily and Noninvasive transcranial magnetic stimulation was administered 10 times daily in people with Treatment Resistant Depression (TRD), run by First Affiliated Hospital of Zhejiang University.
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 6 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: opening soon, as of the sponsor's last update on 18 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
Hamilton Depression Scale (24-items) Total Score Change (time frame: Baseline to end of stimulation period, an average of 5 days). 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 18 Mar 2025.