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pBFS Guided rTMS Over DMPFC for Treatment-Resistant Depression

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05948839
Recruitment Status : Recruiting
First Posted : July 17, 2023
Last Update Posted : December 12, 2023
Sponsor:
Collaborators:
Hebei Mental Health Center
Shandong Daizhuang Hospital
West China Hospital
The Second Affiliated Hospital of Xinxiang Medical University
Information provided by (Responsible Party):
Changping Laboratory

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

Condition or disease Intervention/treatment Phase
Treatment Resistant Depression Major Depressive Disorder Device: active rTMS treatment Device: sham rTMS treatment Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 170 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Personalized Brain Functional Sector-guided rTMS Therapy Targeting DMPFC for Treatment-resistant Depression
Actual Study Start Date : July 11, 2023
Estimated Primary Completion Date : June 1, 2024
Estimated Study Completion Date : September 1, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: active rTMS treatment
3 sessions of active rTMS would be delivered to the left DMPFC daily, with a session of 1800 pulse.
 Device: active rTMS treatment
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 Comparator: sham control
3 sessions of sham rTMS would be delivered to the left DMPFC daily, with a session of 1800 pulse.
 Device: sham rTMS treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. Change in Montgomery-Asberg Depression Rating Scale (MADRS) scores from baseline to Immediate Post-treatment [ Time Frame: Baseline and Day 21(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).


Secondary Outcome Measures :
  1. Remission and response rates were estimated using Montgomery-Asberg Depression Rating Scale(MADRS) [ Time Frame: Baseline, Day 21 (Immediate Post-treatment) ]
    The response is defined as a symptom improvement of ≥50% and remission is defined as a score ≤10 on MADRS

  2. Remission and response rates were estimated using Hamilton Depression Rating Scale (HAMD-17) [ Time Frame: Baseline, Day 21 (Immediate Post-treatment) ]
    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

  3. Changes in the MADRS from baseline to each visit [ Time Frame: Baseline, Day 21 (Immediate Post-treatment), 3-week Post-treatment, 9-week Post-treatment ]
    The MADRS has an overall score ranging from 0 (no depression) to 60 (worst depression). Higher scores represent higher depression severity.

  4. Changes in the HAMD-17 from baseline to each visit [ Time Frame: Baseline, Day 21 (Immediate Post-treatment), 3-week Post-treatment, 9-week Post-treatment ]
    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.

  5. cognitive changes from baseline to day 21(Immediate Post-treatment) [ Time Frame: Baseline, 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)


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • 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.
Contacts and Locations
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05948839


Contacts
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Contact: Meiling Li, Ph.D. 010-80726688 meilingli@cpl.ac.cn

Locations
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China, Hebei
Hebei Mental Health Center Recruiting
Baoding, Hebei, China
Contact: Bing Li         
China
Shandong Daizhuang Hospital Recruiting
Jining, China
Contact: Zhonggang Wang         
The Second Affiliated Hospital of Xinxiang Medical University Recruiting
Xinxiang, China
Contact: Yongfeng Yang         
Sponsors and Collaborators
Changping Laboratory
Hebei Mental Health Center
Shandong Daizhuang Hospital
West China Hospital
The Second Affiliated Hospital of Xinxiang Medical University
Investigators
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Study Chair: Hesheng Liu, Ph.D. Changping Laboratory
More Information
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Responsible Party: Changping Laboratory
ClinicalTrials.gov Identifier: NCT05948839    
Other Study ID Numbers: CPLMDDDM150
First Posted: July 17, 2023    Key Record Dates
Last Update Posted: December 12, 2023
Last Verified: December 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Changping Laboratory:
Treatment Resistant Depression, TRD
Moderate Depression, MDD
personalized neuromodulation
Personalized Brain Functional Sectors
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Depressive Disorder, Major
Depressive Disorder, Treatment-Resistant
 Behavioral Symptoms
Mood Disorders
Mental Disorders