Effect of Individualized Precise TMS on Emotional Blunting in Depression and Its Brain Imaging Mechanism
Depression
About this trial
This is an interventional treatment trial for Depression focused on measuring emotional blunting, transcranial magnetic stimulation
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), The current major depressive episode (MDE) must be confirmed using the Mini International Neuropsychiatric Interview (MINI).
(3) The patient's current MDE time was less than 12 months;
(4) Montgomery-Asberg Depression Rating Scale (MADRS): total MADRS score ≥22 and ≤28;
(5) 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";
(6) Received at least 6 weeks of monotherapy with an SSRI or SNRI prior to enrollment;
(7) 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.
Sites / Locations
- XijingHRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Sham Comparator
TMS true stimulation group
TMS sham stimulation group
Transcranial magnetic stimulation and medication. The stimulation parameters were 10Hz frequency and 120%MT intensity. 50 treatment sequences were given each time, with 60 stimulation times for each sequence, the sequence interval was 30 seconds, and a total of 3000 stimulation times for each treatment. The patients were treated once a day for 15 days. Medical treatment is selective serotonin reuptake inhibitors/serotonin-noradrenaline reuptake inhibitors (SSRIs/SNRIs).
Sham stimulation and medication. The pseudo-stimulation method was to flip the magnetic head at 90 degrees with the scalp, The stimulation parameters were 10Hz frequency and 120%MT intensity. 50 treatment sequences were given each time, with 60 stimulation times for each sequence, the sequence interval was 30 seconds, and a total of 3000 stimulation times for each treatment. The patients were treated once a day for 15 days. Medical treatment is selective serotonin reuptake inhibitors/serotonin-noradrenaline reuptake inhibitors (SSRIs/SNRIs).