Clinical trial NCT05555940: Effect of Individualized Precise TMS on Emotional Blunting in Depression and Its Brain Imaging Mechanism
Official title: Study on the Effect and Brain Influence Mechanism of Individualized Precise Transcranial Magnetic Stimulation Based on Image Analysis on Emotional Blunting in Depression
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Depression
Keywords: emotional blunting
transcranial magnetic stimulation
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2022-09-27
Enrollment: 80
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: This study aims to explore and investigate the therapeutic effect and mechanism of individualized localization of transcranial magnetic stimulation on emotional blunting of depression, improve the understanding of the mechanism of emotional blunting of depression, order to provide new treatment methods and better curative effects for this disease.

Detailed description: Depression is a common mental illness. The traditional treatment is medication, but many patients do not respond well to medication and have side effects such as emotional blunting. emotional blunting is a numbness to both positive and negative emotions. It is estimated that about 40% to 60% of depressed patients who use serotonin (5-HT) reuptake inhibitors (SSRIs) or 5-HT and norepinephrine (NE) reuptake inhibitors (SNRIs) have varying degrees of affective retardation. Repetitive transcranial magnetic stimulation (rTMS) is a safe and non-invasive method for the treatment of depression. Its clinical efficacy is related to the accuracy of the stimulation target. How to carry out individualized accurate positioning is of great significance for improving the therapeutic effect.

Eligibility criteria: Inclusion Criteria:

* (1) Outpatients of all genders, aged ≥18 years and ≤65 years, right-handed, admitted to the psychosomatic Department of Xijing Hospital;

  (2) In accordance with the diagnostic criteria for the depressive disorder of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V)).

  (3) Montgomery-Asberg Depression Rating Scale (MADRS): total MADRS score ≥12;

  (4) The total score of the Oxford Depression Questionnaire (ODQ) at baseline was ≥50, and the answer to the standardized screening question of emotional blunting was "yes";

  (5) Received at least 6 weeks of monotherapy with an SSRI or SNRI prior to enrollment;

  (6) Subjects who can understand and are willing to strictly follow the clinical trial protocol to complete this study and sign informed consent.

Exclusion Criteria:

* (1) Have a history of substance abuse within 6 months before the start of the study;

  (2) Patients with bipolar disorder and depression caused by other mental diseases (such as psychoactive substances and non-dependent substances);

  (3) Have a history of somatic severe diseases or diseases that may affect the central nervous system (such as tumors, syphilis, etc.);

  (4) Have neurological diseases or risk of seizures, such as previous brain diseases, head trauma, alcoholism, EEG abnormalities, MRI evidence of abnormal brain structure, or family history of epilepsy;

  (5) There are contraindications to MRI scanning or transcranial magnetic stimulation treatment, such as metal or electronic instruments (intracranial metal foreign bodies, cochlear implants, cardiac pacemakers, stents, and other metal foreign bodies);

  (6) Have obvious suicide risk, or have actual suicide behavior within 6 months before the start of the study;

  (7) Pregnant, breastfeeding, or planning pregnancy during the trial;

  (8) Other conditions that are not suitable for the study object in the researcher's judgment.

Primary outcomes:
measure: Changes from Baseline on Oxford Depression Questionnaire scores during treatment and at each follow-up point.
timeFrame: At baseline, at the end of treatment on day 7, at the end of treatment on day 15, 2 weeks after treatment, 4 weeks after treatment, and 8 weeks after treatment
Secondary outcomes:
measure: Changes from Baseline on Montgomery-Asberg Depression Rating Scale scores or other clinical scales during treatment and at each follow-up point.
timeFrame: At baseline,at the end of treatment on day 7, at the end of treatment on day 15, 2 weeks after treatment, 4 weeks after treatment, and 8 weeks after treatment
measure: Changes of MRI from baseline to the end of 15 day treatment period.
timeFrame: Before treatment, 15 days
Other outcomes:
Locations:
city: Xi'an
country: China
facility: XijingH
state: Shannxi
Study officials:
References: