The Dosage Effect of pBFS Guided rTMS Treatment for MDD

NCT ID: NCT05842278

Last Updated: 2023-07-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-07
• Study Completion Date: 2024-10-01

Brief Summary

The investigators aim to find the optimal dosage of the pBFS-guided rTMS treatment for patients with moderate to severe depression.

Detailed Description

In 2022, the FDA cleared a large dosage of repetitive transcranial magnetic stimulation for treatment-resistant depression (TRD), which requires 10 sessions per day of 1,800 pulses per session for a total of 18,000 pulses per day. The inter-session interval is 50 min, and it costs patients 9 hours for the intervention. The investigators assume that patients with moderate to severe depression may not need 10 sessions per day, patients may achieve response or remission with a less amount of dosage, which will save the cost of treatment. Hence, the investigators try to find the optimal treatment dosage for patients with moderate to severe depression.

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 1:1:1:1:1 ratio to each active rTMS group with different pulses (4×1800 pulses, 6×1800 pulses, 8×1800 pulses, 10×1800 pulses) and sham-control group. And then all participants will undergo a 5-day rTMS treatment followed by four- and eight weeks follow-up visits. Participants will keep a stable treatment regime during treatment and the four-week follow-up.

Conditions

Moderate Depression; Major Depressive Disorder; Severe Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

4 session rTMS

Four sessions of active rTMS would be delivered to the left DLPFC daily, with a session of 1800 pulse.

Group Type: ACTIVE_COMPARATOR

4 session rTMS

Intervention Type: DEVICE

Participants will receive 4 sessions per day of 1800 pulses per session, lasting for 5 days. Individualized targets will be generated using the pBFS method.

6 session rTMS

Six sessions of active TMS would be delivered to the left DLPFC daily, with a session of 1800 pulse.

Group Type: ACTIVE_COMPARATOR

6 session rTMS

Intervention Type: DEVICE

Participants will receive 6 sessions per day of 1800 pulses per session, lasting for 5 days. Individualized targets will be generated using the pBFS method.

8 session rTMS

Eight sessions of active rTMS would be delivered to the left DLPFC daily, with a session of 1800 pulse.

Group Type: ACTIVE_COMPARATOR

8 session rTMS

Intervention Type: DEVICE

Participants will receive 8 sessions per day of 1800 pulses per session, lasting for 5 days. Individualized targets will be generated using the pBFS method.

10 session rTMS

Ten sessions of active rTMS would be delivered to the left DLPFC daily, with a session of 1800 pulse.

Group Type: ACTIVE_COMPARATOR

10 session rTMS

Intervention Type: DEVICE

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

sham rTMS

Subjects were randomized to receive 4 sessions or 6 sessions or 8 sessions or 10 sessions of sham rTMS to the left DLPFC daily in a 1:1:1:1 ratio.

Group Type: SHAM_COMPARATOR

sham rTMS

Intervention Type: 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.

Interventions

4 session rTMS

Participants will receive 4 sessions per day of 1800 pulses per session, lasting for 5 days. Individualized targets will be generated using the pBFS method.

Intervention Type: DEVICE

6 session rTMS

Participants will receive 6 sessions per day of 1800 pulses per session, lasting for 5 days. Individualized targets will be generated using the pBFS method.

Intervention Type: DEVICE

8 session rTMS

Participants will receive 8 sessions per day of 1800 pulses per session, lasting for 5 days. Individualized targets will be generated using the pBFS method.

Intervention Type: DEVICE

10 session rTMS

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

Intervention Type: DEVICE

sham rTMS

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.

Intervention Type: DEVICE

Eligibility 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 before randomization.
• Total MADRS score of ≥25 before randomization.
• Inadequate response to at least one antidepressant trial of adequate doses and duration.
• Participants currently are on a stable or no-drug use for at least 4 weeks before randomization. The type and dose of antidepressant drugs remained unchanged throughout the intervention period.
• Voluntarily participate in the trial and able to provide 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 plan 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.
• Investigators think that was inappropriate to participate.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing HuiLongGuan Hospital

OTHER

Sponsor Role: collaborator

Changping Laboratory

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hesheng Liu, Ph.D.

Role: STUDY_CHAIR

Changping Laboratory

Locations

Beijing HuiLongGuan Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Meiling Li, Ph.D.

Role: CONTACT

meilingli@cpl.ac.cn

010-80726688

Facility Contacts

Song Chen, MD

Role: primary

Other Identifiers

CPLMDDhlg1

Identifier Type: -

Identifier Source: org_study_id