Moderate DepressionNCT05957341
pBFS Guided 20min Inter-session Interval rTMS Treatment for MDD
A study testing active rTMS: 20min inter-session interval and active rTMS: 50min inter-session interval in people with Moderate Depression and Major Depressive Disorder, run by Changping Laboratory.
Trial summary
The investigators aim to explore the efficacy and safety of rTMS therapies with different intervals between sessions for treating 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?
- active rTMS: 20min inter-session interval and active rTMS: 50min inter-session interval
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 30 Jul 2023to 30 Aug 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
- Meet the diagnostic criteria of DSM-5(Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition) for the depression disorder without psychotic symptoms, and currently experiencing recurrence episodes.
- Hospitalized patients aged 18-65 years (inclusive), male or female.
- Total HAMD-17 score ≥20 before randomization.Total MADRS score ≥25 before randomization.
- Inadequate response to at least one antidepressant trial of adequate doses and duration.
- A stable antidepressant regimen for at least 4 weeks at a dose not lower than the prescribed range of drug use before randomization.
- Voluntarily participate in the trial and sign informed consent.
Who cannot join
- Meet diagnostic criteria for other mental disorders (such as schizophrenia, schizoaffective disorder, bipolar disorder, secondary depression, and so on);
- 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;
- 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, and light therapy within 3 months;
- Patients 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;
- Patients with serious heart, liver, kidney diseases, diabetes, and other serious physical diseases, causing symptoms and signs of brain abnormalities, or body failure;
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- The female of childbearing potential plans to become pregnant during the trial, and the female who is pregnant or breastfeeding.
- Alcohol abuse or drugs abuse in the past 1 year;
- First-degree relatives have bipolar affective disorder. There is a significant risk of suicide (MADRS item 10 ≥ 5).
- Difficulty or inability to engage in normal communication, understand or follow instructions, and cooperate with treatment and evaluators.
- Currently participating in clinical trials of other drugs or physical therapy (e.g. deep brain stimulation DBS, electroconvulsive therapy ECT, rTMS).
- Investigators think that was inappropriate to participate.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Personalized Brain Functional Sectors(pBFS) Guided 20min Inter-session Interval rTMS Treatment for Major Depressive Disorder： a Randomized， Double-Blind， Sham-controlled Trial
The investigators aim to explore the efficacy and safety of rTMS therapies with different intervals between sessions for treating patients with moderate to severe depression.
Read the detailed description
FDA-approved intermittent theta burst stimulation (iTBS) for the treatment of depression disorder, reduces the duration of a single sequence treatment from 37 minutes to 3 minutes with traditional rTMS and gets the same antidepressant effect. Studies have shown that large doses and individualized target stimulation based on iTBS can improve the efficacy of rTMS and greatly save the time spent during patient treatment, but the effect of the interval between iTBS sessions on the efficacy is inconclusive. Previous studies on interval effect in rats based on iTBS have indirectly found that the waiting time between iTBS sessions of 50 to 90 minutes can maximize the cumulative effect of stimulation, so researchers mostly set the iTBS treatment interval to 50 minutes. However, most patients give up treatment because of the long wait time of 50 minutes, so it is urgent to explore the effect of short intervals of iTBS accepted easier by patients. In this study, we examined the intersession interval of 50 min vs. 20 min in the efficacy and safety of pBFS-guided TMS treatment in 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 4:4:1:1 ratio to a 50-minute active rTMS group, a 20-minute active rTMS group, a 50-minute sham-control group, and a 20-minute sham-control group. And then all participants will undergo a 21-day rTMS treatment followed by two-week and four-week follow-up visits.
- Being tested
- active rTMS: 20min inter-session interval, active rTMS: 50min inter-session interval, sham rTMS: 20min inter-session interval, sham rTMS: 50min inter-session interval
- 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.
active rTMS: 20min inter-session intervalDevice
Participants will receive active TMS, with 3 sessions per day, 1800 pulses/session, and 20 min inter-session intervals, lasting for 21 days. Individualized targets will be generated using the pBFS method.
active rTMS: 50min inter-session intervalDevice
Participants will receive active TMS, with 3 sessions per day, 1800 pulses/session, and 50 min inter-session intervals, lasting for 21 days. Individualized targets will be generated using the pBFS method.
sham rTMS: 20min inter-session intervalDevice
The parameters in this group are the same as in the active rTMS: 20min inter-session interval group. Stimulation was delivered by the same device as the active group fitted with a sham coil.
sham rTMS: 50min inter-session intervalDevice
The parameters in this group are the same as in the active rTMS: 50min inter-session interval group. Stimulation was delivered by the same device as the active group fitted with a sham coil.
| Study group | Role | What they receive |
|---|---|---|
| active rTMS: 20min inter-session interval | Experimental | Three sessions of active rTMS would be delivered, with 1800 pulse/session and 20 min inter-session intervals. Receives: Device: active rTMS: 20min inter-session interval |
| active rTMS: 50min inter-session interval | Active comparator | Three sessions of active rTMS would be delivered, with 1800 pulse/session and 50 min inter-session intervals. Receives: Device: active rTMS: 50min inter-session interval |
| sham rTMS: 20min inter-session interval | Sham comparator | Three sessions of sham rTMS would be delivered, with 1800 pulse/session and 20 min inter-session intervals. Receives: Device: sham rTMS: 20min inter-session interval |
| sham rTMS: 50min inter-session interval | Sham comparator | Three sessions of sham rTMS would be delivered, with 1800 pulse/session and 50 min inter-session intervals. Receives: Device: sham rTMS: 50min inter-session interval |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 and Day 21(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 7, Day 14, Day 21, 2-week post-treatment, 4-week post-treatment
change in HAMD
A provider-administered questionnaire was used to assess remission and recovery from depression. The Hamilton Depression Rating Scale (HAMD) 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 HAMD-17 there can be a total score of 52. Higher scores represent higher depression severity
Measured: Baseline, Day 7, Day 14, Day 21, 2-week post-treatment, 4-week post-treatment
change in QID_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 7, Day 14, Day 21, 2-week post-treatment, 4-week post-treatment
change in HAMA
The HAMA was one of the first rating scales developed to measure the severity of anxiety symptoms, and is still widely used today in both clinical and research settings. The scale consists of 14 items, each defined by a series of symptoms, and measures both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety).
Measured: Baseline, Day 7, Day 14, Day 21, 2-week post-treatment, 4-week post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2023
- Study start30 Jul 2023 (estimated)
- Primary completion30 Jul 2024 (estimated)
- Study completion30 Aug 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changping Laboratory
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hesheng Liu, Ph.D., Study chair, Changping Laboratory
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05957341
- Sponsor's protocol ID
- CPLMDDinterP
- Status last verified
- Jul 2023
- First submitted
- 14 Jul 2023
- Last updated
- 24 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Brain Functional Sectors(pBFS) Guided 20min Inter-session Interval rTMS Treatment for Major Depressive Disorder： a Randomized， Double-Blind， Sham-controlled Trial
- ClinicalTrials.gov ID
- NCT05957341
- Acronym / sponsor ID
- CPLMDDinterP
- Keywords
- transcranial magnetic stimulation, rTMS, Major Depression, Moderate Depression, MDD, personalized neuromodulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Changping LaboratoryUniversity, hospital or other
- Study start
- 30 Jul 2023 (estimated)
- Primary completion
- 30 Jul 2024 (estimated)
- Study completion
- 30 Aug 2024 (estimated)
- First posted
- 24 Jul 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 explore the efficacy and safety of rTMS therapies with different intervals between sessions for treating patients with moderate to severe depression.
Detailed description
FDA-approved intermittent theta burst stimulation (iTBS) for the treatment of depression disorder, reduces the duration of a single sequence treatment from 37 minutes to 3 minutes with traditional rTMS and gets the same antidepressant effect. Studies have shown that large doses and individualized target stimulation based on iTBS can improve the efficacy of rTMS and greatly save the time spent during patient treatment, but the effect of the interval between iTBS sessions on the efficacy is inconclusive. Previous studies on interval effect in rats based on iTBS have indirectly found that the waiting time between iTBS sessions of 50 to 90 minutes can maximize the cumulative effect of stimulation, so researchers mostly set the iTBS treatment interval to 50 minutes. However, most patients give up treatment because of the long wait time of 50 minutes, so it is urgent to explore the effect of short intervals of iTBS accepted easier by patients. In this study, we examined the intersession interval of 50 min vs. 20 min in the efficacy and safety of pBFS-guided TMS treatment in 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 4:4:1:1 ratio to a 50-minute active rTMS group, a 20-minute active rTMS group, a 50-minute sham-control group, and a 20-minute sham-control group. And then all participants will undergo a 21-day rTMS treatment followed by two-week and four-week follow-up visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| active rTMS: 20min inter-session interval | Experimental | Device: active rTMS: 20min inter-session intervalThree sessions of active rTMS would be delivered, with 1800 pulse/session and 20 min inter-session intervals. |
| active rTMS: 50min inter-session interval | Active comparator | Device: active rTMS: 50min inter-session intervalThree sessions of active rTMS would be delivered, with 1800 pulse/session and 50 min inter-session intervals. |
| sham rTMS: 20min inter-session interval | Sham comparator | Device: sham rTMS: 20min inter-session intervalThree sessions of sham rTMS would be delivered, with 1800 pulse/session and 20 min inter-session intervals. |
| sham rTMS: 50min inter-session interval | Sham comparator | Device: sham rTMS: 50min inter-session intervalThree sessions of sham rTMS would be delivered, with 1800 pulse/session and 50 min inter-session intervals. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Meet the diagnostic criteria of DSM-5(Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition) for the depression disorder without psychotic symptoms, and currently experiencing recurrence episodes.
- Hospitalized patients aged 18-65 years (inclusive), male or female.
- Total HAMD-17 score ≥20 before randomization.Total MADRS score ≥25 before randomization.
- Inadequate response to at least one antidepressant trial of adequate doses and duration.
- A stable antidepressant regimen for at least 4 weeks at a dose not lower than the prescribed range of drug use before randomization.
Key exclusion criteria (12 listed)
- Meet diagnostic criteria for other mental disorders (such as schizophrenia, schizoaffective disorder, bipolar disorder, secondary depression, and so on);
- 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;
- 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, and light therapy within 3 months;
- Patients 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;
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 |
|---|---|---|
| active rTMS: 20min inter-session intervalParticipants will receive active TMS, with 3 sessions per day, 1800 pulses/session, and 20 min inter-session intervals, lasting for 21 days. Individualized targets will be generated using the pBFS method. | Device | active rTMS: 20min inter-session interval |
| active rTMS: 50min inter-session intervalParticipants will receive active TMS, with 3 sessions per day, 1800 pulses/session, and 50 min inter-session intervals, lasting for 21 days. Individualized targets will be generated using the pBFS method. | Device | active rTMS: 50min inter-session interval |
| sham rTMS: 20min inter-session intervalThe parameters in this group are the same as in the active rTMS: 20min inter-session interval group. Stimulation was delivered by the same device as the active group fitted with a sham coil. | Device | sham rTMS: 20min inter-session interval |
| sham rTMS: 50min inter-session intervalThe parameters in this group are the same as in the active rTMS: 50min inter-session interval group. Stimulation was delivered by the same device as the active group fitted with a sham coil. | Device | sham rTMS: 50min inter-session interval |
Primary outcome
change in MADRS
Time frame: Baseline and Day 21(immediate post-treatment)
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
4 secondary outcomes
change in MADRS
Time frame: Baseline, Day 7, Day 14, Day 21, 2-week post-treatment, 4-week post-treatment
change in HAMD
Time frame: Baseline, Day 7, Day 14, Day 21, 2-week post-treatment, 4-week post-treatment
change in QID_SR
Time frame: Baseline, Day 7, Day 14, Day 21, 2-week post-treatment, 4-week post-treatment
change in HAMA
Time frame: Baseline, Day 7, Day 14, Day 21, 2-week post-treatment, 4-week post-treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 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
Questions about this trial
What is this clinical trial studying?
A study testing active rTMS: 20min inter-session interval and active rTMS: 50min inter-session interval in people with Moderate Depression and Major Depressive Disorder, run by Changping Laboratory.
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 12 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 24 Jul 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hesheng Liu, Ph.D. (010-80726688, heshengliu@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 MADRS (time frame: Baseline and Day 21(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 24 Jul 2023.