NCT05957341

Brief Summary

The investigators aim to explore the efficacy and safety of rTMS therapies with different intervals between sessions for treating patients with moderate to severe depression.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2023

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 14, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 24, 2023

Completed
6 days until next milestone

Study Start

First participant enrolled

July 30, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2024

Completed
Last Updated

July 24, 2023

Status Verified

July 1, 2023

Enrollment Period

1 year

First QC Date

July 14, 2023

Last Update Submit

July 14, 2023

Conditions

Moderate DepressionMajor Depressive DisorderSevere Depression

Keywords

transcranial magnetic stimulation, rTMSMajor Depression, Moderate Depression, MDDpersonalized neuromodulation

Outcome Measures

Primary Outcomes (1)

  • change in MADRS

    A provider-administered questionnaire was used to assess remission and recovery from depression. The MADRS is a ten-item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders. The MADRS has an overall score range from 0-60, with higher scores corresponding to higher levels of depression

    Baseline and Day 21(immediate post-treatment)

Secondary Outcomes (4)

  • change in MADRS

    Baseline, Day 7, Day 14, Day 21, 2-week post-treatment, 4-week post-treatment

  • change in HAMD

    Baseline, Day 7, Day 14, Day 21, 2-week post-treatment, 4-week post-treatment

  • change in QID_SR

    Baseline, Day 7, Day 14, Day 21, 2-week post-treatment, 4-week post-treatment

  • change in HAMA

    Baseline, Day 7, Day 14, Day 21, 2-week post-treatment, 4-week post-treatment

Study Arms (4)

active rTMS: 20min inter-session interval

EXPERIMENTAL

Three sessions of active rTMS would be delivered, with 1800 pulse/session and 20 min inter-session intervals.

Device: active rTMS: 20min inter-session interval

active rTMS: 50min inter-session interval

ACTIVE COMPARATOR

Three sessions of active rTMS would be delivered, with 1800 pulse/session and 50 min inter-session intervals.

Device: active rTMS: 50min inter-session interval

sham rTMS: 20min inter-session interval

SHAM COMPARATOR

Three sessions of sham rTMS would be delivered, with 1800 pulse/session and 20 min inter-session intervals.

Device: sham rTMS: 20min inter-session interval

sham rTMS: 50min inter-session interval

SHAM COMPARATOR

Three sessions of sham rTMS would be delivered, with 1800 pulse/session and 50 min inter-session intervals.

Device: sham rTMS: 50min inter-session interval

Interventions

active rTMS: 20min inter-session intervalDEVICE

Participants will receive active TMS, with 3 sessions per day, 1800 pulses/session, and 20 min inter-session intervals, lasting for 21 days. Individualized targets will be generated using the pBFS method.

active rTMS: 20min inter-session interval
active rTMS: 50min inter-session intervalDEVICE

Participants will receive active TMS, with 3 sessions per day, 1800 pulses/session, and 50 min inter-session intervals, lasting for 21 days. Individualized targets will be generated using the pBFS method.

active rTMS: 50min inter-session interval
sham rTMS: 20min inter-session intervalDEVICE

The parameters in this group are the same as in the active rTMS: 20min inter-session interval group. Stimulation was delivered by the same device as the active group fitted with a sham coil.

sham rTMS: 20min inter-session interval
sham rTMS: 50min inter-session intervalDEVICE

The parameters in this group are the same as in the active rTMS: 50min inter-session interval group. Stimulation was delivered by the same device as the active group fitted with a sham coil.

sham rTMS: 50min inter-session interval

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Meet the diagnostic criteria of DSM-5(Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition) for the depression disorder without psychotic symptoms, and currently experiencing recurrence episodes.
  • Hospitalized patients aged 18-65 years (inclusive), male or female.
  • Total HAMD-17 score ≥20 before randomization.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.

You may not qualify if:

  • Meet diagnostic criteria for other mental disorders (such as schizophrenia, schizoaffective disorder, bipolar disorder, secondary depression, and so on);
  • 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;
  • 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, and light therapy within 3 months;
  • Patients 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;
  • Patients with serious heart, liver, kidney diseases, diabetes, and other serious physical diseases, causing symptoms and signs of brain abnormalities, or body failure;
  • The female of childbearing potential plans to become pregnant during the trial, and the female who is pregnant or breastfeeding.
  • Alcohol abuse or drugs abuse in the past 1 year;
  • 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.
  • Currently participating in clinical trials of other drugs or physical therapy (e.g. deep brain stimulation DBS, electroconvulsive therapy ECT, rTMS).
  • Investigators think that was inappropriate to participate.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Depressive Disorder, MajorDepression

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental DisordersBehavioral SymptomsBehavior

Study Officials

  • Hesheng Liu, Ph.D.

    Changping Laboratory

    STUDY CHAIR

Central Study Contacts

Hesheng Liu, Ph.D.

CONTACT

010-80726688heshengliu@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

July 14, 2023

First Posted

July 24, 2023

Study Start

July 30, 2023

Primary Completion

July 30, 2024

Study Completion

August 30, 2024

Last Updated

July 24, 2023

Record last verified: 2023-07