pBFS-guided rTMS Over DMPFC for Treatment-Resistant Depression

NCT06350396 | Recruiting DMC

• 1 other identifier: CPLTRDDM2024
• Study Type: interventional
• Target: 270
• Locations: 1 country
• Sites: 5

Brief Summary

This study is a multicenter, randomized, double-blind, placebo-controlled trial aimed at exploring the effectiveness and safety of rTMS intervention with DMPFC targets guided by pBFS in patients with treatment-resistant depression.

Conditions

Treatment Resistant Depression; Major Depressive Disorder

Keywords

Treatment Resistant Depression; Major Depression, Moderate Depression, MDD; personalized neuromodulation; Personalized Brain Functional Sectors

Outcome Measures

Primary Outcomes (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).

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

Secondary Outcomes (8)

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

  Baseline, Day 21 (Immediate Post-treatment)

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

  Baseline, Day 21 (Immediate Post-treatment)

• Changes in the MADRS from baseline to each visit

  Baseline, Day 21 (Immediate Post-treatment), 3-week Post-treatment, 9-week, and 6-month Post-treatment

• Changes in the HAMD-17 from baseline to each visit

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

• cognitive change in Digit Symbol Substitution Test (DSST)

  Baseline, Day 21 (Immediate Post-treatment)

Study Arms (2)

active rTMS treatment

EXPERIMENTAL

3 sessions of active rTMS would be delivered to the left DMPFC daily, with 1800 pulse/session.

Device: active rTMS treatment

sham control

SHAM COMPARATOR

The identical treatment parameters will be administered akin to the active rTMS treatment, albeit devoid of actual stimulation.

Device: sham rTMS treatment

Interventions

active rTMS treatment DEVICE

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.

active rTMS treatment

sham rTMS treatment DEVICE

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.

sham control

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (1) Patients who meet the diagnostic criteria for depression in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) and are not accompanied by psychiatric symptoms, with single or repeated episodes;
• (2) The Hamilton Depression Scale (HAMD) score for 17 items before randomization was ≥ 20 points, and the Montgomery Asberg Depression Rating Scale (MADRS) score was ≥ 20 points;
• (3) Individuals aged ≥ 18 and ≤ 65 years old, regardless of gender;
• (4) Currently, at least one antidepressant has been used for 6 weeks and the dosage used cannot be lower than the prescribed range of drug use;
• (5) The Maudsley Staging Method (MSM) assesses patients as having at least moderate refractory levels (MSM score ≥ 7);
• (6) Before randomization, the current antidepressant treatment regimen should be stable for at least 4 weeks, and the dosage used should not be lower than the prescribed range of drug use;
• (7) Having received education for 5 years or more;
• (8) Understand the experiment and sign an informed consent form.

You may not qualify if:

• (1) Meets the DSM-5 diagnostic criteria for other mental disorders, including schizophrenia spectrum disorders, bipolar and related disorders, neurodevelopmental disorders, neurocognitive disorders, or depression caused by substances and/or drugs, or depression caused by other medical issues;
• (2) Individuals with pacemakers, cochlear implants, or other metal foreign objects, as well as any electronic devices implanted in the body, contraindications for magnetic resonance imaging scans such as claustrophobia, and contraindications for rTMS treatment;
• (3) Concomitant history of epilepsy (with at least 2 non induced seizures with an interval of more than 24 hours, diagnosed with epilepsy syndrome, or having seizures within the past 12 months);
• (4) Individuals who have received modified electroconvulsive mECT, rTMS, or light therapy within 3 months;
• (5) Concomitant organic brain diseases (such as ischemic stroke, cerebral hemorrhage, brain tumors, etc.) and a history of severe brain injury;
• (6) Complicated with serious heart, liver, kidney diseases, diabetes and other serious physical diseases;
• (7) Women of childbearing age who are currently pregnant, breastfeeding, or planning or may become pregnant during the trial period;
• (8) Have a history of drug and alcohol abuse within the past year;
• (9) First degree relatives suffer from bipolar disorder;
• (10) There is a significant risk of suicide (the 10th item of the MADRS scale is ≥ 5 points);
• (11) Difficulty in verbal communication to the point of being unable to communicate normally, understand or follow instructions, and unable to cooperate with treatment and evaluation;
• (12) Currently participating in clinical trials of other drugs or physical therapies (such as deep brain stimulation (DBS), electroconvulsive therapy (ECT), rTMS);
• (13) The researchers believe it is not suitable to participate.

Sponsors & Collaborators

• Changping Laboratory: lead

Study Sites (5)

Hebei Mental Health Center

Hebei, Baoding, China

RECRUITING

West China Hospital, Sichuan University

Chengdu, China

NOT YET RECRUITING

Inner Mongolia Mental Health Center

Hohhot, China

RECRUITING

Shandong Daizhuang Hospital

Jining, China

NOT YET RECRUITING

The Second Affiliated Hospital of Xinxiang Medical University

Xinxiang, China

RECRUITING

MeSH Terms

Conditions

Depressive Disorder, Treatment-Resistant; Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Hesheng Liu, Ph.D.

  Changping Laboratory

  STUDY CHAIR

Central Study Contacts

Meiling Li, Ph.D.

CONTACT

010-80726688; meilingli@cpl.ac.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2024
• First Posted: April 5, 2024
• Study Start: April 17, 2024
• Primary Completion: December 30, 2024
• Study Completion: June 30, 2025
• Last Updated: May 7, 2024

Record last verified: 2024-05

Locations

CN (5)