Clinical trial NCT05964023: pBFS Guided VS "5-cm Rule" rTMS Over DLPFC for MDD
Official title: Personalized Brain Functional Sector-guided rTMS Therapy Targeting DLPFC VS "5-centimeter Rule" for Major Depression
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Major Depression
MDD
Keywords: Major Depression, MDD
pBFS,
5cm rule
Lead sponsor: Changping Laboratory
Sponsor class: OTHER
First posted: 2023-07-27
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators aim to investigate whether the intervention effect of pBFS-guided rTMS therapy targeting DLPFC is superior to the intervention effect of the traditional "5 cm-rule" guided rTMS therapy in patients with depressive disorders.

Detailed description: 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 blind manner in a 1:1 ratio to the pBFS group, or 5-cm rule group. Then all participants will undergo a 21-day rTMS modulation and 7-day, 14-day, and 45-day post-treatment follow-up visits. Participants will not take any other treatment during the intervention and the 7-day and 14-day post-treatment visits.

Eligibility criteria: Inclusion Criteria:

* 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.
* Inpatients or outpatients 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.
* Currently not taking any antidepressant medication. If previously medicated, a washout period of 7 days is required.
* Voluntarily participate in the trial and sign 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 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 plans to become pregnant during the trial and the 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.

Primary outcomes:
measure: Changes in Montgomery-Asberg Depression Rating Scale (MADRS) scores
timeFrame: Baseline and Day 21
Secondary outcomes:
measure: changes in MADRS
timeFrame: Baseline, Day 7, Day 14, Day 21 (immediate post-treatment), 7-day post-treatment, 14-day post-treatment, 45-day post-treatment
measure: changes in HAMD
timeFrame: Baseline, Day 7, Day 14, Day 21 (immediate post-treatment), 7-day post-treatment, 14-day post-treatment, 45-day post-treatment
measure: cognitive change in Digit Symbol Substitution Test (DSST)
timeFrame: Baseline, Day 21 (Immediate Post-treatment)
measure: cognitive change in continuous performance test (CPT)
timeFrame: Baseline, Day 21 (Immediate Post-treatment)
measure: cognitive change in Trail-Making Test (TMT)
timeFrame: Baseline, Day 21 (Immediate Post-treatment)
measure: cognitive change in Digit Span Test (DST)
timeFrame: Baseline, Day 21 (Immediate Post-treatment)
Other outcomes:
Locations:
city: Baoding
country: China
facility: Hebei Mental Health Center
state: Hebei
city: Xinxiang
country: China
facility: Henan Mental Hospital
state: Henan
city: Tianjin
country: China
facility: Tianjin general hospital
state: Tianjin
city: Hanzhou
country: China
facility: Hangzhou Seventh People's Hospital
state: Zhejiang
Study officials:
affiliation: Changping Laboratory
name: Hesheng Liu, Ph.D.
role: STUDY_CHAIR
References: