Treatment-resistant DepressionNCT05607654
The Mechanisms of Underlying Accelerated Repetitive Transcranial Magnetic Stimulation for Treatment-resistant Depression
A study testing active iTBS in people with Treatment-resistant Depression, run by First Affiliated Hospital of Zhejiang University at 1 site in China.
Trial summary
In this project, the investigators evaluate an accelerated schedule of repetitive transcranial magnetic stimulation for treatment-resistant depression. The investigators focuse on participants' brain activity and blood markers (Reelin, Apoer2, NMDAR, BDNF, exosomes and so on) to deepen the understanding of the… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Treatment-resistant Depression
- What is being tested?
- active iTBS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2023to 31 Dec 2026
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- The current episode met the DSM-5 diagnostic criteria for major depression in patients with first-episode or relapsed unmedicated depression without psychotic symptoms.
- 24-item Hamilton Depression Scale (HAMD-24) ≥ 20.
- Age 18-45 years, regardless of gender.
- Right-handedness.
- Han Chinese.
- Signed a written informed consent, willing to participate in the study and be evaluated.
Who cannot join
- Co-morbid other mental disorders, including: schizophrenia, mental retardation, substance dependence, etc.
- Patients with metal objects in the body or with other contraindications to MRI scanning
- Patients with severe or unstable somatic diseases
- Women during pregnancy or lactation, and women of childbearing age with positive urine HCG test results during the screening period
- Other conditions that, in the opinion of the investigator, exist that make participation in this clinical trial inappropriate.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang, 310000
Manli Huang, M.D, 13957162975 ext. 86, huangmanli@zju.edu.cn
About this study
Official title: The Mechanisms of Underlying Accelerated Repetitive Transcranial Magnetic Stimulation for Treatment-resistant Depression Via Reelin-Apoer2-NMDAR Pathway- Mediated Synaptic Plasticity
In this project, the investigators evaluate an accelerated schedule of repetitive transcranial magnetic stimulation for treatment-resistant depression. The investigators focuse on participants' brain activity and blood markers (Reelin, Apoer2, NMDAR, BDNF, exosomes and so on) to deepen the understanding of the mechanism of accelerated rTMS for treatment-resistant depression.
Read the detailed description
In this project, the investigator evaluate an accelerated schedule of repetitive transcranial magnetic stimulation for treatment-resistant depression. Patients were included in two groups and received an accelerated stimulation or sham treatment. The changes of neuroimaging and biomarkers at baseline, 5 days after treatment and 1 month after treatment are evaluated. The investigators focuse on participants' brain activity and blood markers (Reelin, Apoer2, NMDAR, BDNF, exosomes and so on) to deepen the understanding of the mechanism of accelerated rTMS for treatment-resistant depression.
- Conditions
- Treatment-resistant Depression
- Being tested
- active iTBS, sham rTMS
- Keywords
- Treatment-resistant Depression, Repeated transcranial magnetic stimulation, Prefrontal-hippocampal circuit, Reelin, Synaptic plasticity
- 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.
active iTBSDevice
Participants in the active stimulation group will receive the accelerated intermittent TBS to left DLPFC. The L-DLPFC will be targeted utilizing the neuronavigation system. Stimulation intensity will be standardized at 90% of RMT.
Stimulation will be delivered to the L-DLPFC using an NTK-TMS-II100 TMS device,is compatible with the Brainsight TMS navigation system.
sham rTMSDevice
The parameters in the sham arm will be as above with the internal randomization of the device internally switching to sham in a blinded fashion.
| Study group | Role | What they receive |
|---|---|---|
| active iTBS | Active comparator | The active group of TRD will receive the accelerated intermittent TBS(iTBS).The iTBS cycles including 10 bursts of three pulses at 50 Hz were delivered in 2-second trains. Each iTBS session comprised 60 x 2 second trains, with an 8-second intertrain interval and total duration of 10-minutes.Treatment sessions were administered hourly 10 times a day totaling 18,000 pulses/day. Patients received this treatment protocol for 5 consecutive days (90,000 pulses in total). Receives: Device: active iTBS |
| sham rTMS | Sham comparator | The sham group of TRD will receive sham rTMS stimulation. Receives: Device: sham rTMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in remission rate of Hamilton Depression Scale (24-items) (HAM-D24) score after treatment.
The Hamilton Depression Scale (24-items) (HAM-D24), is a 24 item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders. 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.
Measured: Baseline, 5-day, 1-month
Secondary outcomes (3)
Change in response rate of Hamilton Depression Scale (24-items) (HAM-D24) score after treatment.
The Hamilton Depression Scale (24-items) (HAM-D24), is a 24 item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders. Higher HAM-D24 score indicates more severe depression, and each item yields a score of 0 to 4.
Response is defined as a reduction of >/=50% of HAM-D24 baseline score.
Measured: Baseline, 5-day, 1-month
Change in the rate of Beck Scale of Suicidal Ideation score after treatment.
Beck Scale of Suicidal Ideation(BSI) is a 21-item self-report instrument that detects and measures the intensity of a patient's specific attitudes, behaviors, and suicide plans during the past week.
Measured: Baseline, 5-day, 1-month
Change in the rate of Hamilton Anxiety Scale score after treatment.
Hamilton Anxiety Scale (HAMA) is a 17 item diagnostic questionnaire used to measure the severity of anxiety episodes in patients
Measured: Baseline, 5-day, 1-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2022
- Study start1 Jan 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Treatment-resistant DepressionStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 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
- NCT05607654
- Sponsor's protocol ID
- 82271562
- Status last verified
- Sep 2022
- First submitted
- 26 Oct 2022
- Last updated
- 13 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Mechanisms of Underlying Accelerated Repetitive Transcranial Magnetic Stimulation for Treatment-resistant Depression Via Reelin-Apoer2-NMDAR Pathway- Mediated Synaptic Plasticity
- ClinicalTrials.gov ID
- NCT05607654
- Acronym / sponsor ID
- 82271562
- Conditions
- Treatment-resistant Depression
- Keywords
- Treatment-resistant Depression, Repeated transcranial magnetic stimulation, Prefrontal-hippocampal circuit, Reelin, Synaptic plasticity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Zhejiang UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 7 Nov 2022 (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.
In this project, the investigators evaluate an accelerated schedule of repetitive transcranial magnetic stimulation for treatment-resistant depression. The investigators focuse on participants' brain activity and blood markers (Reelin, Apoer2, NMDAR, BDNF, exosomes and so on) to deepen the understanding of the mechanism of accelerated rTMS for treatment-resistant depression.
Detailed description
In this project, the investigator evaluate an accelerated schedule of repetitive transcranial magnetic stimulation for treatment-resistant depression. Patients were included in two groups and received an accelerated stimulation or sham treatment. The changes of neuroimaging and biomarkers at baseline, 5 days after treatment and 1 month after treatment are evaluated. The investigators focuse on participants' brain activity and blood markers (Reelin, Apoer2, NMDAR, BDNF, exosomes and so on) to deepen the understanding of the mechanism of accelerated rTMS for treatment-resistant depression.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| active iTBS | Active comparator | Device: active iTBSThe active group of TRD will receive the accelerated intermittent TBS(iTBS).The iTBS cycles including 10 bursts of three pulses at 50 Hz were delivered in 2-second trains. Each iTBS session comprised 60 x 2 second trains, with an 8-second intertrain interval and total duration of 10-minutes.Treatment sessions were administered hourly 10 times a day totaling 18,000 pulses/day. Patients received this treatment protocol for 5 consecutive days (90,000 pulses in total). |
| sham rTMS | Sham comparator | Device: sham rTMSThe sham group of TRD will receive sham rTMS stimulation. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- The current episode met the DSM-5 diagnostic criteria for major depression in patients with first-episode or relapsed unmedicated depression without psychotic symptoms.
- 24-item Hamilton Depression Scale (HAMD-24) ≥ 20.
- Age 18-45 years, regardless of gender.
- Right-handedness.
- Han Chinese.
Key exclusion criteria (5 listed)
- Co-morbid other mental disorders, including: schizophrenia, mental retardation, substance dependence, etc.
- Patients with metal objects in the body or with other contraindications to MRI scanning
- Patients with severe or unstable somatic diseases
- Women during pregnancy or lactation, and women of childbearing age with positive urine HCG test results during the screening period
- Other conditions that, in the opinion of the investigator, exist that make participation in this clinical trial inappropriate.
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 iTBSParticipants in the active stimulation group will receive the accelerated intermittent TBS to left DLPFC. The L-DLPFC will be targeted utilizing the neuronavigation system. Stimulation intensity will be standardized at 90% of RMT. Stimulation will be delivered to the L-DLPFC using an NTK-TMS-II100 TMS device,is compatible with the Brainsight TMS navigation system. | Device | active iTBS |
| sham rTMSThe parameters in the sham arm will be as above with the internal randomization of the device internally switching to sham in a blinded fashion. | Device | sham rTMS |
Primary outcome
Change in remission rate of Hamilton Depression Scale (24-items) (HAM-D24) score after treatment.
Time frame: Baseline, 5-day, 1-month
The Hamilton Depression Scale (24-items) (HAM-D24), is a 24 item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders. 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.
3 secondary outcomes
Change in response rate of Hamilton Depression Scale (24-items) (HAM-D24) score after treatment.
Time frame: Baseline, 5-day, 1-month
Change in the rate of Beck Scale of Suicidal Ideation score after treatment.
Time frame: Baseline, 5-day, 1-month
Change in the rate of Hamilton Anxiety Scale score after treatment.
Time frame: Baseline, 5-day, 1-month
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 13 Jan 2023.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing active iTBS in people with Treatment-resistant Depression, run by First Affiliated Hospital of Zhejiang 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 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: looking for participants now, as of the sponsor's last update on 13 Jan 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?
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?
Contact Manli Huang, M.D (13957162975 ext. 86, huangmanli@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in remission rate of Hamilton Depression Scale (24-items) (HAM-D24) score after treatment. (time frame: Baseline, 5-day, 1-month). 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 13 Jan 2023.