Treatment Resistant DepressionNCT06166082

Intensive Accelerated iTBS for the Treatment-Resistant Depression

A study testing Active iTBS-DLPFC in people with Treatment Resistant Depression, run by Changping Laboratory at 5 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 22 to 65 years
Conditions the study is for: Treatment Resistant Depression
What is being tested?: Active iTBS-DLPFC
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 130 participants
Where: 5 sitesChina
Study dates: 22 Dec 2023to 21 Apr 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 22 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 depression disorder without psychotic symptoms, and currently experiencing a recurrence episode;
Hamilton Depression Scale (HAMD-17) scores for 17 items ≥ 20 points, and the Montgomery Asberg Depression Rating Scale (MADRS) score is ≥ 20 points;
hospitalized/outpatient patients aged ≥ 22 and ≤ 65 years old, male or female;
The Maudsley Staging Method (MSM) assesses patients as at least moderate refractory (MSM score ≥ 7 points);
Stable use of antidepressants for 4 weeks before randomization, with the type of antidepressant used being selective serotonin reuptake Selective serotonin reuptake inhibitors (SSRIs) or/and serotonin and norepinephrine reuptake Serotonin-norepinephrine reuptake inhibitors (SNRIs), the therapeutic dose is within the dosage range as the drug manual recommended;
Understand the trial and sign the informed consent form.

Who cannot join

Meets DSM-5 diagnostic criteria for other mental disorders, including schizophrenia spectrum disorders, bipolar and related disorders, and psychiatric disorders Developmental disorders, neurocognitive disorders, or depression caused by substances and/or drugs, or other medical problems;
Individuals with pacemakers, cochlear implants, or other metal objects, as well as any electronic devices implanted in the body, and those with claustrophobia Contraindications for magnetic resonance imaging scans such as fear, and contraindications for 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 Syndromes, or seizures within the past 12 months;
Received TMS treatment before participating in the trial;
Individuals who have received ECT or phototherapy within three months;
No response to ECT treatment (>8 times);

Show all 16Show fewer

Previously received antidepressant treatment with implanted devices (such as DBS, VNS);
Concomitant organic brain diseases (such as ischemic stroke, cerebral hemorrhage, brain tumors, etc.) and a history of severe brain injury;
Complicated with serious heart, liver, kidney diseases, diabetes, and other serious physical diseases, which cause abnormal symptoms and signs of brain nerves, Or physical exhaustion;
Women of childbearing age who are currently pregnant, breastfeeding, or planning or may become pregnant during the trial period;
Substance abuse or dependence (including alcohol, drugs, and other psychoactive substances) in the past year;
First-degree relatives suffer from bipolar disorder;
High risk of suicide;
Difficulty in communication to understand or follow instructions, and unable to cooperate with treatment and evaluation;
Current in clinical trials of other drugs or physical therapies (DBS, ECT, rTMS);
The researchers believe it is not suitable to participate.

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

China5 sites

Hebei Mental Health Center
Baoding
HuiLongGuan Hospital
Beijing
Wuhan Mental Health Center
Wuhan
Xianyue Hospital
Xiamen
Zhumadian Second People's Hospital
Zhumadian

Other trials in China

About this study

Official title: Intensive Accelerated Intermittent Theta Burst Stimulation in Treatment-resistant Depression: A Multicenter, Randomized, Double-blind, Placebo Parallel Controlled Trial

This study is a multicenter, randomized, double-blind, and sham-controlled trial using most intensive aiTBS protocol (10 sessions daily over 5 consecutive days at triple the standard per-session dose) to investigate the antidepressant efficacy for treatment-resistant depression (TRD). Patients will be recruited and randomly assigned (1:1 ratio) to receive active or sham groups from 5 hospitals in China. The interventions will last for 5 days and both groups will be followed up for 8 weeks on the same time schedules. During the intervention and at least the first 4 weeks of post-treatment, participants will keep a stable antidepressant regimen. The individualized target in the left dorsolateral prefrontal cortex (DLPFC) will be generated from 30 minutes of resting-state functional MRI collected at baseline.

Read the detailed description

Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive neuromodulation technique approved by the U.S. Food and Drug Administration (FDA) for the treatment of TRD. Despite FDA approval, conventional TMS is limited by a remission rate of approximately one-third and a prolonged treatment schedule of 4-6 weeks, which poses substantial practical and accessibility challenges.

Accelerated TMS protocols-delivering multiple sessions per day to compress standard multi-week regimens into just a few days-offer a potential strategy to enhance accessibility and accelerate clinical response. In 2022, the FDA approved a high-dose intervention, Stanford Neuromodulation Therapy (SNT), for rapid symptom relief in TRD. This protocol administers 10 sessions of 1,800-pulse iTBS per day over five consecutive days to the DLPFC, with 50-minute inter-session intervals. At treatment end, the response rate was 71.4% (vs. 13.3% in the sham group); at the 4-week follow-up, the response rate was 69.2% (vs. 7.1% in the sham group). Although these findings have generated optimism for patients with TRD, the efficacy and safety of accelerated iTBS (aiTBS) require further validation in multicenter, randomized, double-blind, placebo-controlled parallel-group trials

Conditions: Treatment Resistant Depression
Being tested: Active iTBS-DLPFC, Sham iTBS-DLPFC
Keywords: Treatment Resistant Depression, TRD
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 iTBS-DLPFCDevice
Participants will receive 10 sessions per day of 1800 pulses per session, lasting for 5 days.
Sham iTBS-DLPFCDevice
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 groups in NCT06166082
Study group	Role	What they receive
Active iTBS-DLPFC	Experimental	The active group will receive active iTBS. Treat 10 times a day with 1800 pulses per day for consecutive 5 days, with 50 minutes inter-session intervals. Receives: Device: Active iTBS-DLPFC
Sham iTBS-DLPFC	Sham comparator	The sham group will receive sham iTBS. Treat 10 times a day with 1800 pulses per day for consecutive 5 days, with 50 minutes inter-session intervals. Receives: Device: Sham iTBS-DLPFC

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)
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: Pretreatment (baseline), 28 days post-treatment

Secondary outcomes (9)

Change in MADRS
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), 7 days Post-treatment, 14 days Post-treatment, 21 days Post-treatment, 56 days Post-treatment]
Change in the Hamilton Rating Scale for Depression (HAMD-17)
A provider administered questionnaire used to assess remission and recovery from depression. The HAMD-17 is a 17-item questionnaire to assess depression severity. Each item is scored from 0-4, with higher scores representing increasing depression severity.
Measured: Baseline, Day 5 (Immediate Post-treatment), 7 days Post-treatment, 14 days Post-treatment, 21 days Post-treatment, 28 days Post-treatment, 56 days Post-treatment]
Change in the Hamilton Rating Scale for Depression (HAMD-6) Score
The Hamilton Depression Rating Scale (HDRS, also known as Ham-D) is the most widely used clinician-administered depression assessment scale.
The Ham-6 version consists of 6 items assessing for: 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 symptoms item, which is scored 0 to 2. On the HAM-6 there can be a total score of 22. Higher scores represent higher depression severity. Here, we report a count of participants with an overall increase, decrease or no change in total HAM-6 score.
Participants with an increase in total score (row 3) would signify a worse outcome than participants with a decrease in total score.
Measured: Baseline, Day 1, 2, 3, 4 in treatment, Day 5 (Immediate Post-treatment), 7 days Post-treatment, 14 days Post-treatment, 21 days Post-treatment, 28 days Post-treatment, 56 days Post-treatment]
Change in Quick Inventory of Depressive Symptomatology Self-Report (QIDS_SR)
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), 7 days Post-treatment, 14 days Post-treatment, 21 days Post-treatment, 28 days Post-treatment, 56 days Post-treatment]
Safety estimated using YMRS
Young Mania Rating Scale(YMARS) measures mania
Measured: Baseline, Day 5 (Immediate Post-treatment)
cognitive change in Digit Symbol Substitution Test (DSST）
Cognitive scores are measured using Chinese brief cognitive test (C-BCT), the DSST equires a subject to match symbols to numbers according to a key located on the top of the page
Measured: Baseline, Day 5(Immediate Post-treatment)
cognitive change in continuous performance test (CPT）
CPT from the C-BCT measures a person's sustained and selective attention
Measured: Baseline, Day 5(Immediate Post-treatment)
cognitive change in Trail-Making Test (TMT)
The TMT test from the C-BCT can provide information about visual search speed, scanning, speed of processing, mental flexibility, and executive functioning
Measured: Baseline, Day 5(Immediate Post-treatment)
cognitive change in Digit Span Test (DST)
DST from the C-BCT is a measure of verbal short term and working memory that can be used in two formats, Forward Digit Span and Reverse Digit Span
Measured: Baseline, Day 5(Immediate Post-treatment)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 Dec 202321 Apr 2025

First posted12 Dec 2023
Study start22 Dec 2023
Primary completion21 Mar 2025
Study completion21 Apr 2025

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.
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: 130 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06166082
Sponsor's protocol ID: CPL TRD_aiTBS_Multicenter
Status last verified: May 2026
First submitted: 3 Dec 2023
Last updated: 11 May 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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RecruitingPhase 1
Mechanism of Action Underlying Ketamine's Antidepressant Effects: The AMPA Throughput Theory in Patients With Treatment-Resistant Major Depression
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Recruiting
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All Treatment Resistant Depression trials

Study at a glance

From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Intensive Accelerated Intermittent Theta Burst Stimulation in Treatment-resistant Depression: A Multicenter, Randomized, Double-blind, Placebo Parallel Controlled Trial
ClinicalTrials.gov ID: NCT06166082
Acronym / sponsor ID: CPL TRD_aiTBS_Multicenter
Conditions: Treatment Resistant Depression
Keywords: Treatment Resistant Depression, TRD
Study type: Interventional
Recruitment status: Completed
Enrolment: 130 participants (actual)
Lead sponsor: Changping LaboratoryUniversity, hospital or other
Collaborators: Xianyue Hospital, Xiamen, Hebei Mental Health Center, Baoding, Beijing HuiLongGuan Hospital, Wuhan Mental Health Centre, Zhumadian Second People's Hospital, Zhumadian
Study start: 22 Dec 2023 (actual)
Primary completion: 21 Mar 2025 (actual)
Study completion: 21 Apr 2025 (actual)
First posted: 12 Dec 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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Active iTBS-DLPFC	Experimental	Device: Active iTBS-DLPFCThe active group will receive active iTBS. Treat 10 times a day with 1800 pulses per day for consecutive 5 days, with 50 minutes inter-session intervals.
Sham iTBS-DLPFC	Sham comparator	Device: Sham iTBS-DLPFCThe sham group will receive sham iTBS. Treat 10 times a day with 1800 pulses per day for consecutive 5 days, with 50 minutes inter-session intervals.

Who may qualify

Ages: 22 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 depression disorder without psychotic symptoms, and currently experiencing a recurrence episode;
Hamilton Depression Scale (HAMD-17) scores for 17 items ≥ 20 points, and the Montgomery Asberg Depression Rating Scale (MADRS) score is ≥ 20 points;
hospitalized/outpatient patients aged ≥ 22 and ≤ 65 years old, male or female;
The Maudsley Staging Method (MSM) assesses patients as at least moderate refractory (MSM score ≥ 7 points);
Stable use of antidepressants for 4 weeks before randomization, with the type of antidepressant used being selective serotonin reuptake Selective serotonin reuptake inhibitors (SSRIs) or/and serotonin and norepinephrine reuptake Serotonin-norepinephrine reuptake inhibitors (SNRIs), the therapeutic dose is within the dosage range as the drug manual recommended;

Key exclusion criteria (16 listed)

Meets DSM-5 diagnostic criteria for other mental disorders, including schizophrenia spectrum disorders, bipolar and related disorders, and psychiatric disorders Developmental disorders, neurocognitive disorders, or depression caused by substances and/or drugs, or other medical problems;
Individuals with pacemakers, cochlear implants, or other metal objects, as well as any electronic devices implanted in the body, and those with claustrophobia Contraindications for magnetic resonance imaging scans such as fear, and contraindications for 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 Syndromes, or seizures within the past 12 months;
Received TMS treatment before participating in the trial;
Individuals who have received ECT or phototherapy within three 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
Active iTBS-DLPFCParticipants will receive 10 sessions per day of 1800 pulses per session, lasting for 5 days.	Device	Active iTBS-DLPFC
Sham iTBS-DLPFCThe 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 iTBS-DLPFC

Primary outcome

Change in Montgomery-Asberg Depression Rating Scale (MADRS)
Time frame: Pretreatment (baseline), 28 days post-treatment
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.

9 secondary outcomes

Change in MADRS
Time frame: Baseline, Day 5 (Immediate Post-treatment), 7 days Post-treatment, 14 days Post-treatment, 21 days Post-treatment, 56 days Post-treatment]
Change in the Hamilton Rating Scale for Depression (HAMD-17)
Time frame: Baseline, Day 5 (Immediate Post-treatment), 7 days Post-treatment, 14 days Post-treatment, 21 days Post-treatment, 28 days Post-treatment, 56 days Post-treatment]
Change in the Hamilton Rating Scale for Depression (HAMD-6) Score
Time frame: Baseline, Day 1, 2, 3, 4 in treatment, Day 5 (Immediate Post-treatment), 7 days Post-treatment, 14 days Post-treatment, 21 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), 7 days Post-treatment, 14 days Post-treatment, 21 days Post-treatment, 28 days Post-treatment, 56 days Post-treatment]
Safety estimated using YMRS
Time frame: Baseline, Day 5 (Immediate Post-treatment)
cognitive change in Digit Symbol Substitution Test (DSST）
Time frame: Baseline, Day 5(Immediate Post-treatment)
cognitive change in continuous performance test (CPT）
Time frame: Baseline, Day 5(Immediate Post-treatment)
cognitive change in Trail-Making Test (TMT)
Time frame: Baseline, Day 5(Immediate Post-treatment)
cognitive change in Digit Span Test (DST)
Time frame: Baseline, Day 5(Immediate Post-treatment)

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2026.

Related trials for Treatment Resistant Depression

Recruiting
Regulated Stimulation for Optimized Network Activity and Therapeutic Equilibrium
Major Depressive Disorder
Enrolling by invitation
Vagus Nerve Stimulation (VNS) Electroencephalogram (EEG) Protocol Supplement
Treatment Resistant Depression
RecruitingPhase 1
Mechanism of Action Underlying Ketamine's Antidepressant Effects: The AMPA Throughput Theory in Patients With Treatment-Resistant Major Depression
Depression, Major Depressive Disorder
Recruiting
rTMS to Target Neural Connectivity and Rumination in Treatment-Resistant Depression
Depression, Treatment Resistant
Recruiting
Ketogenic Diet and Neuromodulation in Treatment Resistant Depression
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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

5 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Active iTBS-DLPFC in people with Treatment Resistant Depression, run by Changping Laboratory at 5 sites 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 16 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: finished, as of the sponsor's last update on 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Change in Montgomery-Asberg Depression Rating Scale (MADRS) (time frame: Pretreatment (baseline), 28 days post-treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06166082.

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 11 May 2026.