pBFS Guided rTMS Over DMPFC for Treatment-Resistant Depression

NCT05948839 | Unknown DMC

• 1 other identifier: CPLMDDDM150
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Treatment Resistant Depression; Major Depressive Disorder

Keywords

Treatment Resistant Depression, TRD; 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).

  Baseline and Day 21(Immediate Post-treatment)]

Secondary Outcomes (5)

• 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 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 changes from baseline to day 21(Immediate Post-treatment)

  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 a session of 1800 pulse.

Device: active rTMS treatment

sham control

SHAM COMPARATOR

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

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:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Changping Laboratory: lead
• Hebei Mental Health Center: collaborator
• Shandong Daizhuang Hospital: collaborator
• West China Hospital: collaborator
• The Second Affiliated Hospital of Xinxiang Medical University: collaborator

Study Sites (3)

Hebei Mental Health Center

Baoding, Hebei, China

RECRUITING

Shandong Daizhuang Hospital

Jining, China

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: June 29, 2023
• First Posted: July 17, 2023
• Study Start: July 11, 2023
• Primary Completion: June 1, 2024
• Study Completion: September 1, 2024
• Last Updated: December 12, 2023

Record last verified: 2023-12

Locations

CN (3)