pBFS-guided High-dose TMS Over DMPFC for Treatment-resistant Major Depressive Disorder

NCT05964036 | Unknown

• 1 other identifier: CPLMDDHidoseDM
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators aim to evaluate the safety and efficacy of pBFS-guided DMPFC target and high-dose rTMS therapy for the treatment of patients with treatment-resistant depression

Conditions

Depression; Major Depressive Disorder; Severe Depression

Keywords

transcranial magnetic stimulation, rTMS; DMPFC; pBFS; precision target

Outcome Measures

Primary Outcomes (1)

• change in Montgomery-Asberg Depression Rating Scale (MADRS)

  The 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, Day 5

Secondary Outcomes (9)

• Change in MADRS

  Baseline, Day 5 (Immediate Post-treatment), 14 days Post-treatment, 28 days Post-treatment

• Change in Hamilton Depression Scale (HAMD-17)

  Baseline, Day 5 (Immediate Post-treatment), 14 days Post-treatment, 28 days Post-treatment

• Change in Quick Inventory of Depressive Symptomatology Self-Report (QIDS_SR)

  Baseline, Day 5 (Immediate Post-treatment), 14 days Post-treatment, 28 days Post-treatment

• cognitive change in Digit Symbol Substitution Test (DSST)

  Baseline, Day 5 (Immediate Post-treatment)

• cognitive change in continuous performance test (CPT)

  Baseline, Day 5 (Immediate Post-treatment)

Study Arms (2)

active TMS

EXPERIMENTAL

active iTBS coupled with medical therapy

Device: active TMS

sham TMS

SHAM COMPARATOR

Sham iTBS coupled with medical therapy

Device: sham TMS

Interventions

active TMS DEVICE

Participants will receive 10 sessions per day of 1800 pulses per session, lasting for 5 days. Individualized target in the DMPFC will be generated using the pBFS method

active TMS

sham TMS DEVICE

The parameters in the sham arm are the same as in the active stimulation group. Stimulation was delivered by the same device as the active group fitted with a sham coil

sham TMS

Eligibility Criteria

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

You may qualify if:

• DSM-5 diagnosis of depressive disorder, recurrent episodes;
• A total score of at least 20 on the HAMD-17 and Montgomery-Asberg Depression Rating Scale;
• Aged 18-65 years, female or male;
• Inadequate response to at least one antidepressant trial of adequate doses and duration;
• The MSM (Maudsley Staging Method) score ≥ 7;
• Stable antidepressant regimen for at least 4 weeks before treatment;
• Understand the trial and sign the informed consent.

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;
• The female of childbearing potential who plans to become pregnant during the trial, and 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.
• 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

Study Sites (1)

Hebei Mental Health Center

Baoding, Hebei, China

RECRUITING

MeSH Terms

Conditions

Depression; Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• hesheng Liu

  Changping Laboratory

  STUDY CHAIR

Central Study Contacts

Meiling Li, phd

CONTACT

13540014981; limeilingcheng@163.com

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: July 12, 2023
• First Posted: July 27, 2023
• Study Start: July 21, 2023
• Primary Completion: April 20, 2024
• Study Completion: July 20, 2024
• Last Updated: February 7, 2024

Record last verified: 2023-07

Locations

CN (1)