Moderate DepressionNCT05842278
The Dosage Effect of pBFS Guided rTMS Treatment for MDD
A study testing 4 session rTMS, 6 session rTMS and 8 session rTMS in people with Moderate Depression and Major Depressive Disorder, run by Changping Laboratory at 1 site in China.
Trial summary
The investigators aim to find the optimal dosage of the pBFS-guided rTMS treatment for patients with moderate to severe depression. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Moderate Depression, Major Depressive Disorder, Severe Depression
- What is being tested?
- 4 session rTMS, 6 session rTMS and 8 session rTMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 7 Jul 2023to 1 Oct 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hospitalized/outpatient patients aged 18-65 years (inclusive), male or female.
- Meet the diagnostic criteria of DSM-5(Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition) for depression disorder without psychotic symptoms, and currently experiencing a recurrence episode.
- Total HAMD17 score ≥20 before randomization.
- Total MADRS score of ≥25 before randomization.
- Inadequate response to at least one antidepressant trial of adequate doses and duration.
- Participants currently are on a stable or no-drug use for at least 4 weeks before randomization. The type and dose of antidepressant drugs remained unchanged throughout the intervention period.
- Voluntarily participate in the trial and able to provide informed consent. Able to comply with the planned visit, examination and treatment plan, and other study procedures.
Who cannot join
- Meet DSM-5 diagnostic criteria for other mental disorders (such as schizophrenia spectrum disorders, bipolar and related disorders, neurodevelopmental disorders, neurocognitive disorders, or depressive disorders due to substances and/or medications, depressive disorders due to other medical problems, etc.);
- Patients with a cardiac pacemaker, cochlear implant, or other metal foreign body and any electronic equipment implanted in the body, patients with claustrophobia and other contraindications to magnetic resonance scanning, and patients with contraindications to rTMS treatment;
- Patients with serious or unstable diseases of the cardiovascular, liver, kidney, blood, endocrine, neurological system, and other systems or organs, especially those with organic brain diseases (such as ischemic stroke, cerebral hemorrhage, brain tumor, etc.) and a history of severe brain trauma as judged by the researcher;
- History of epilepsy (presence of at least 2 uninduced seizures more than 24 hours apart, or diagnosis of the epileptic syndrome, or seizures within the past 12 months); Or currently received medications or other treatments that will lower the seizure threshold;
- History of ECT, rTMS, VNS, DBS, tDCS, light therapy, or other physical therapy related to mental illness within 3 months;
- Currently receiving or plan to start formal cognitive or behavioral therapy, or systemic psychological therapy (interpersonal therapy, dynamic therapy, cognitive behavioral therapy, etc.) during the trial;
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- Substance abuse or dependence (including alcohol, drugs, and other psychoactive substances) in the past 1 year;
- Female of childbearing potential who plans to become pregnant during the trial.
- Female that is pregnant or breastfeeding.
- Patients in any clinical trials of other drugs or physical therapy within 1 month before the screening.
- Investigators think that was inappropriate to participate.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing HuiLongGuan Hospital
Beijing, Beijing Municipality, 100096
Song Chen, MD
About this study
Official title: The Dosage Effect of Personalized Brain Functional Sectors(pBFS) Guided rTMS Treatment for Major Depressive Disorder： a Randomized， Double-Blind， Sham-controlled Trial
The investigators aim to find the optimal dosage of the pBFS-guided rTMS treatment for patients with moderate to severe depression.
Read the detailed description
In 2022, the FDA cleared a large dosage of repetitive transcranial magnetic stimulation for treatment-resistant depression (TRD), which requires 10 sessions per day of 1,800 pulses per session for a total of 18,000 pulses per day. The inter-session interval is 50 min, and it costs patients 9 hours for the intervention. The investigators assume that patients with moderate to severe depression may not need 10 sessions per day, patients may achieve response or remission with a less amount of dosage, which will save the cost of treatment. Hence, the investigators try to find the optimal treatment dosage for patients with moderate to severe depression.
After being informed about the study and potential risks. All patients giving written informed consent will undergo a screening period to determine eligibility for study entry. At week 0, patients who meet the eligibility requirements will be randomized in a double-blind manner in a 1:1:1:1:1 ratio to each active rTMS group with different pulses (4×1800 pulses, 6×1800 pulses, 8×1800 pulses, 10×1800 pulses) and sham-control group. And then all participants will undergo a 5-day rTMS treatment followed by four- and eight weeks follow-up visits. Participants will keep a stable treatment regime during treatment and the four-week follow-up.
- Being tested
- 4 session rTMS, 6 session rTMS, 8 session rTMS, 10 session rTMS, sham rTMS
- Keywords
- transcranial magnetic stimulation, rTMS, Major Depression, Moderate Depression, MDD, personalized neuromodulation
- Medical subject headings
- Depressive Disorder, Major, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
4 session rTMSDevice
Participants will receive 4 sessions per day of 1800 pulses per session, lasting for 5 days. Individualized targets will be generated using the pBFS method.
6 session rTMSDevice
Participants will receive 6 sessions per day of 1800 pulses per session, lasting for 5 days. Individualized targets will be generated using the pBFS method.
8 session rTMSDevice
Participants will receive 8 sessions per day of 1800 pulses per session, lasting for 5 days. Individualized targets will be generated using the pBFS method.
10 session rTMSDevice
Participants will receive 10 sessions per day of 1800 pulses per session, lasting for 5 days. Individualized targets will be generated using the pBFS method.
sham rTMSDevice
The parameters in the sham arms are the same as the active stimulation groups. Stimulation was delivered by the same device as the active group fitted with a sham coil.
| Study group | Role | What they receive |
|---|---|---|
| 4 session rTMS | Active comparator | Four sessions of active rTMS would be delivered to the left DLPFC daily, with a session of 1800 pulse. Receives: Device: 4 session rTMS |
| 6 session rTMS | Active comparator | Six sessions of active TMS would be delivered to the left DLPFC daily, with a session of 1800 pulse. Receives: Device: 6 session rTMS |
| 8 session rTMS | Active comparator | Eight sessions of active rTMS would be delivered to the left DLPFC daily, with a session of 1800 pulse. Receives: Device: 8 session rTMS |
| 10 session rTMS | Active comparator | Ten sessions of active rTMS would be delivered to the left DLPFC daily, with a session of 1800 pulse. Receives: Device: 10 session rTMS |
| sham rTMS | Sham comparator | Subjects were randomized to receive 4 sessions or 6 sessions or 8 sessions or 10 sessions of sham rTMS to the left DLPFC daily in a 1:1:1:1 ratio. Receives: Device: sham rTMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Montgomery-Asberg Depression Rating Scale (MADRS) scores from baseline to Immediate Post-treatment
The MADRS is a validated instrument stratifying the severity of depressive episodes in adults. The MADRS has an overall score ranging from 0 (no depression) to 60 (worst depression).
Measured: Baseline, Day 5(Immediate Post-treatment)
Secondary outcomes (4)
Change in MADRS
A provider-administered questionnaire was used to assess remission and recovery from depression. The MADRS is a ten-item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders. The MADRS has an overall score range from 0-60, with higher scores corresponding to higher levels of depression.
Measured: Baseline, Day 5 (Immediate Post-treatment), 14 days Post-treatment, 28 days Post-treatment, 56 days Post-treatment
Change in Hamilton Depression Scale (HAMD-17)
A provider-administered questionnaire was used to assess remission and recovery from depression. The Hamilton Depression Rating Scale (HDRS, or Ham-D) is the most widely used clinician-administered depression assessment scale. The Ham-17 version consists of 17 items assessing mood, guilt, general somatic symptoms, work and activities, anxiety, and slowness of thought and speech. Each item is scored on a scale of 0 to 4, except for the somatic, sleep, and insight items which are scored 0 to 2. On the HAM-17 there can be a total score of 22. Higher scores represent higher depression severity.
Measured: Baseline, Day 5 (Immediate Post-treatment), 14 days Post-treatment, 28 days Post-treatment, 56 days Post-treatment
Change in Quick Inventory of Depressive Symptomatology Self-Report (QIDS_SR)
A provider-administered questionnaire was used to assess remission and recovery from depression. The 16-item QIDS_SR is a widely used self-report instrument covering depressive symptoms incorporating nine Diagnostic and Statistical Manual of Mental Disorder-IV (DSM-IV) diagnostic criteria for major depressive disorders. Each item is scored on a scale of 0 to 4. Higher scores represent higher depression severity.
Measured: Baseline, Day 5 (Immediate Post-treatment), 14 days Post-treatment, 28 days Post-treatment, 56 days Post-treatment
Safety estimated using SSI, YMRS
Scale for Suicide Ideation (SSI) measures suicide ideation, Young Mania Rating Scale(YMARS) measures mania
Measured: Baseline, Day 5 (Immediate Post-treatment), 14 days Post-treatment, 28 days Post-treatment, 56 days Post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start7 Jul 2023
- Primary completion31 Jul 2024 (estimated)
- Study completion1 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moderate DepressionStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changping Laboratory
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing HuiLongGuan Hospital
- Responsible party
- Sponsor
- Investigators
- Hesheng Liu, Ph.D., Study chair, Changping Laboratory
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05842278
- Sponsor's protocol ID
- CPLMDDhlg1
- Status last verified
- Jul 2023
- First submitted
- 24 Apr 2023
- Last updated
- 14 Jul 2023
- 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 14 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Dosage Effect of Personalized Brain Functional Sectors(pBFS) Guided rTMS Treatment for Major Depressive Disorder： a Randomized， Double-Blind， Sham-controlled Trial
- ClinicalTrials.gov ID
- NCT05842278
- Acronym / sponsor ID
- CPLMDDhlg1
- Keywords
- transcranial magnetic stimulation, rTMS, Major Depression, Moderate Depression, MDD, personalized neuromodulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Changping LaboratoryUniversity, hospital or other
- Collaborators
- Beijing HuiLongGuan Hospital
- Study start
- 7 Jul 2023 (actual)
- Primary completion
- 31 Jul 2024 (estimated)
- Study completion
- 1 Oct 2024 (estimated)
- First posted
- 6 May 2023 (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.
The investigators aim to find the optimal dosage of the pBFS-guided rTMS treatment for patients with moderate to severe depression.
Detailed description
In 2022, the FDA cleared a large dosage of repetitive transcranial magnetic stimulation for treatment-resistant depression (TRD), which requires 10 sessions per day of 1,800 pulses per session for a total of 18,000 pulses per day. The inter-session interval is 50 min, and it costs patients 9 hours for the intervention. The investigators assume that patients with moderate to severe depression may not need 10 sessions per day, patients may achieve response or remission with a less amount of dosage, which will save the cost of treatment. Hence, the investigators try to find the optimal treatment dosage for patients with moderate to severe depression.
After being informed about the study and potential risks. All patients giving written informed consent will undergo a screening period to determine eligibility for study entry. At week 0, patients who meet the eligibility requirements will be randomized in a double-blind manner in a 1:1:1:1:1 ratio to each active rTMS group with different pulses (4×1800 pulses, 6×1800 pulses, 8×1800 pulses, 10×1800 pulses) and sham-control group. And then all participants will undergo a 5-day rTMS treatment followed by four- and eight weeks follow-up visits. Participants will keep a stable treatment regime during treatment and the four-week follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 4 session rTMS | Active comparator | Device: 4 session rTMSFour sessions of active rTMS would be delivered to the left DLPFC daily, with a session of 1800 pulse. |
| 6 session rTMS | Active comparator | Device: 6 session rTMSSix sessions of active TMS would be delivered to the left DLPFC daily, with a session of 1800 pulse. |
| 8 session rTMS | Active comparator | Device: 8 session rTMSEight sessions of active rTMS would be delivered to the left DLPFC daily, with a session of 1800 pulse. |
| 10 session rTMS | Active comparator | Device: 10 session rTMSTen sessions of active rTMS would be delivered to the left DLPFC daily, with a session of 1800 pulse. |
| sham rTMS | Sham comparator | Device: sham rTMSSubjects were randomized to receive 4 sessions or 6 sessions or 8 sessions or 10 sessions of sham rTMS to the left DLPFC daily in a 1:1:1:1 ratio. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Hospitalized/outpatient patients aged 18-65 years (inclusive), male or female.
- Meet the diagnostic criteria of DSM-5(Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition) for depression disorder without psychotic symptoms, and currently experiencing a recurrence episode.
- Total HAMD17 score ≥20 before randomization.
- Total MADRS score of ≥25 before randomization.
- Inadequate response to at least one antidepressant trial of adequate doses and duration.
Key exclusion criteria (11 listed)
- Meet DSM-5 diagnostic criteria for other mental disorders (such as schizophrenia spectrum disorders, bipolar and related disorders, neurodevelopmental disorders, neurocognitive disorders, or depressive disorders due to substances and/or medications, depressive disorders due to other medical problems, etc.);
- Patients with a cardiac pacemaker, cochlear implant, or other metal foreign body and any electronic equipment implanted in the body, patients with claustrophobia and other contraindications to magnetic resonance scanning, and patients with contraindications to rTMS treatment;
- Patients with serious or unstable diseases of the cardiovascular, liver, kidney, blood, endocrine, neurological system, and other systems or organs, especially those with organic brain diseases (such as ischemic stroke, cerebral hemorrhage, brain tumor, etc.) and a history of severe brain trauma as judged by the researcher;
- History of epilepsy (presence of at least 2 uninduced seizures more than 24 hours apart, or diagnosis of the epileptic syndrome, or seizures within the past 12 months); Or currently received medications or other treatments that will lower the seizure threshold;
- History of ECT, rTMS, VNS, DBS, tDCS, light therapy, or other physical therapy related to mental illness within 3 months;
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 |
|---|---|---|
| 4 session rTMSParticipants will receive 4 sessions per day of 1800 pulses per session, lasting for 5 days. Individualized targets will be generated using the pBFS method. | Device | 4 session rTMS |
| 6 session rTMSParticipants will receive 6 sessions per day of 1800 pulses per session, lasting for 5 days. Individualized targets will be generated using the pBFS method. | Device | 6 session rTMS |
| 8 session rTMSParticipants will receive 8 sessions per day of 1800 pulses per session, lasting for 5 days. Individualized targets will be generated using the pBFS method. | Device | 8 session rTMS |
| 10 session rTMSParticipants will receive 10 sessions per day of 1800 pulses per session, lasting for 5 days. Individualized targets will be generated using the pBFS method. | Device | 10 session rTMS |
| sham rTMSThe parameters in the sham arms are the same as the active stimulation groups. Stimulation was delivered by the same device as the active group fitted with a sham coil. | Device | sham rTMS |
Primary outcome
Change in Montgomery-Asberg Depression Rating Scale (MADRS) scores from baseline to Immediate Post-treatment
Time frame: Baseline, Day 5(Immediate Post-treatment)
The MADRS is a validated instrument stratifying the severity of depressive episodes in adults. The MADRS has an overall score ranging from 0 (no depression) to 60 (worst depression).
4 secondary outcomes
Change in MADRS
Time frame: Baseline, Day 5 (Immediate Post-treatment), 14 days Post-treatment, 28 days Post-treatment, 56 days Post-treatment
Change in Hamilton Depression Scale (HAMD-17)
Time frame: Baseline, Day 5 (Immediate Post-treatment), 14 days Post-treatment, 28 days Post-treatment, 56 days Post-treatment
Change in Quick Inventory of Depressive Symptomatology Self-Report (QIDS_SR)
Time frame: Baseline, Day 5 (Immediate Post-treatment), 14 days Post-treatment, 28 days Post-treatment, 56 days Post-treatment
Safety estimated using SSI, YMRS
Time frame: Baseline, Day 5 (Immediate Post-treatment), 14 days Post-treatment, 28 days Post-treatment, 56 days Post-treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2023.
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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.
Hesheng Liu, Ph.D. study chair
Changping Laboratory
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 4 session rTMS, 6 session rTMS and 8 session rTMS in people with Moderate Depression and Major Depressive Disorder, run by Changping Laboratory 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 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: status not confirmed, as of the sponsor's last update on 14 Jul 2023. 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 Meiling Li, Ph.D. (010-80726688, meilingli@cpl.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Montgomery-Asberg Depression Rating Scale (MADRS) scores from baseline to Immediate Post-treatment (time frame: Baseline, Day 5(Immediate Post-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 14 Jul 2023.