AzTrials
AzTrials

Treatment Resistant DepressionNCT05948839

pBFS Guided rTMS Over DMPFC for Treatment-Resistant Depression

A study testing active rTMS treatment in people with Treatment Resistant Depression and Major Depressive Disorder, run by Changping Laboratory at 3 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

Investigators aim to evaluate the safety and efficacy of pBFS-guided rTMS therapy targeting DMPFC for patients with treatment-resistant depression Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
active rTMS treatment
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
170 participants
Where
3 sitesChina
Study dates
11 Jul 2023to 1 Sep 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 and 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. 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 planning to start formal cognitive or behavioral therapy, or systemic psychological therapy (interpersonal therapy, dynamic therapy, cognitive behavioral therapy, etc.) during the trial.
Show all 14Show fewer
  • 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.
  • 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.
  • Investigators think that was inappropriate to participate.

Trial locations and contacts

3 sites in 1 country.

Meiling Li, Ph.D. contact

010-80726688

meilingli@cpl.ac.cn

China3 sites, 3 recruiting

  • Hebei Mental Health Center

    Baoding, Hebei

    Bing Li

    Recruiting

  • Shandong Daizhuang Hospital

    Jining

    Zhonggang Wang

    Recruiting

  • The Second Affiliated Hospital of Xinxiang Medical University

    Xinxiang

    Yongfeng Yang

    Recruiting

Other trials in China

About this study

Official title: Personalized Brain Functional Sector-guided rTMS Therapy Targeting DMPFC for Treatment-resistant Depression

Investigators aim to evaluate the safety and efficacy of pBFS-guided rTMS therapy targeting DMPFC for patients with treatment-resistant depression

Read the detailed description

Repetitive transcranial magnetic stimulation (rTMS) is an established therapy for treatment-resistant depression. The dorsomedial prefrontal cortex (DMPFC), which serves as a connection intermediary of the aberrant functional network in cognitive control and rumination in depression, has been shown to be highly correlated with disease manifestations and post-treatment improvements through several studies involving neuroimaging and brain injury. Research has shown that the response of DMPFC to rTMS is more subject to improving the dimensions of anxiety and insomnia in depression. Therefore, exploring the novel target DMPFC is also beneficial for distinguishing disease dimensions in the future, thereby enabling personalized treatment and improving clinical treatment efficacy.

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 2:1 ratio to the active rTMS group, or sham-control group. Then all participants will undergo a 21-day rTMS modulation and a three- and nine-week follow-up visit.

Being tested
active rTMS treatment, sham rTMS treatment
Keywords
Treatment Resistant Depression, TRD, Moderate Depression, MDD, personalized neuromodulation, Personalized Brain Functional Sectors
Medical subject headings
Depressive Disorder, Treatment-Resistant, Depressive Disorder, Major

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • active rTMS treatmentDevice

    Participants will receive 3 sessions per day of 1800 pulses per session, lasting for 21 days. Individualized targets will be generated using the pBFS method.

  • sham rTMS treatmentDevice

    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 NCT05948839
Study groupRoleWhat they receive
active rTMS treatmentExperimental3 sessions of active rTMS would be delivered to the left DMPFC daily, with a session of 1800 pulse.
Receives: Device: active rTMS treatment
sham controlSham comparator3 sessions of sham rTMS would be delivered to the left DMPFC daily, with a session of 1800 pulse.
Receives: Device: sham rTMS treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Montgomery-Asberg Depression Rating Scale (MADRS) scores from baseline to Immediate Post-treatment

    The Montgomery-Asberg Depression Rating Scale (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 and Day 21(Immediate Post-treatment)]

Secondary outcomes (5)

  1. Remission and response rates were estimated using Montgomery-Asberg Depression Rating Scale(MADRS)

    The response is defined as a symptom improvement of ≥50% and remission is defined as a score ≤10 on MADRS

    Measured: Baseline, Day 21 (Immediate Post-treatment)

  2. Remission and response rates were estimated using Hamilton Depression Rating Scale (HAMD-17)

    The Hamilton Depression Rating Scale (HAMD) is the most widely used clinician-administered depression assessment scale. The HAMD-17 version consists of 17 items，and has an overall score ranging from 0 (no depression) to 52 (worst depression). Higher scores represent higher depression severity. The response is defined as a symptom improvement of ≥50% and remission is defined as a score ≤7 on HAMD-17

    Measured: Baseline, Day 21 (Immediate Post-treatment)

  3. Changes in the MADRS from baseline to each visit

    The MADRS has an overall score ranging from 0 (no depression) to 60 (worst depression). Higher scores represent higher depression severity.

    Measured: Baseline, Day 21 (Immediate Post-treatment), 3-week Post-treatment, 9-week Post-treatment

  4. Changes in the HAMD-17 from baseline to each visit

    The Hamilton Depression Rating Scale (HAMD) is the most widely used clinician-administered depression assessment scale. The HAMD-17 version consists of 17 items，and has an overall score ranging from 0 (no depression) to 52 (worst depression). Higher scores represent higher depression severity.

    Measured: Baseline, Day 21 (Immediate Post-treatment), 3-week Post-treatment, 9-week Post-treatment

  5. cognitive changes from baseline to day 21(Immediate Post-treatment)

    Cognitive scores are measured using Chinese brief cognitive test (C-BCT), including Digit Symbol Substitution Test (DSST), continuous performance test (CPT), Trail-Making Test (TMT), Digit Span Test (DST)

    Measured: Baseline, Day 21 (Immediate Post-treatment)

Timeline

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

  1. First posted17 Jul 2023
  2. Study start11 Jul 2023
  3. Primary completion1 Jun 2024 (estimated)
  4. Study completion1 Sep 2024 (estimated)

Resources

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
170 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05948839
Sponsor's protocol ID
CPLMDDDM150
Status last verified
Dec 2023
First submitted
29 Jun 2023
Last updated
12 Dec 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing active rTMS treatment in people with Treatment Resistant Depression and Major Depressive Disorder, run by Changping Laboratory at 3 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 14 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 12 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 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?

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 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?

On the ClinicalTrials.gov record for NCT05948839.

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 12 Dec 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in