depressive disorder
Conditions
Interventions
L-leucine group: L-leucine and high-frequency iTBS antidepressant treatment
Sponsors
Nanyang Fourth People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: ? Age 18-55 (inclusive); ? Evaluated by a psychiatrist according to the Brief International Neuropsychiatric Interview (MINI-C) and all subjects met the DSM-5 diagnostic criteria for depressive episodes; ? Male or female, right-handed; ? There were no contraindications to transcranial magnetic stimulation on EEG; ? No use of antidepressants or other psychotropic drugs 4 weeks prior to randomisation and during the intervention; if psychotherapy was available prior to enrolment, it must have been in a stable state of treatment for at least 3 months prior to entry into the study, and there was no change in the frequency or focus of treatment during the study period in the psychotherapy programme; no systematic psychotherapy was done after enrolment in the group for those without psychotherapy; if there was previous treatment with MECT or TMS prior to enrolment, completion of the programme must have at least been more than 3 months; (vi) Hamilton Depression Scale 17-item score =18; Young's Mania Scale score =8; ? Patients gave informed consent, participated in the study voluntarily, and were able to comply with the treatment plan; (viii) Passed the TMS Adult Safety Screening (TASS) questionnaire.
Exclusion criteria
Exclusion criteria: ? Drug allergy; ? Exclusion of other psychoactive substances, non-dependent substance-induced depression or psychogenic depression, co-morbid obsessive-compulsive disorder/schizophrenia, substance abuse or addiction, and a history of manic/hypomanic episodes; ? Persons at high risk of causing harm to themselves or others (Physician's Assessment of Individual Suicide Risk Scale); ? Currently pregnant, breastfeeding or planning to become pregnant; ? International Neuropsychiatric Interview (MINI) diagnosis of other primary psychiatric diagnoses that have been assessed by the Fellow as primary and result in greater impairment than major depression; (vi) Previous MECT or ineffective ECT treatment within the previous 6 months; currently (or within the past 4 weeks) taking lorazepam or any other benzodiazepine; ? Patients who cannot tolerate conventional iTBS treatment; (viii) Have any serious neurological condition or injury, including but not limited to: any condition that may be associated with increased intracranial pressure, occupational brain injury, any history of epilepsy, cerebral aneurysm, Parkinson's disease, Huntington's chorea, multiple sclerosis, loss of consciousness for more than or equal to 5 minutes from a severe head trauma; or have intracranial implants (e.g., aneurysm clips, shunts, stimulators, cochlear implants or electrodes) or implants in or near the head. ) or any other metal object (other than a mouth) in or near the head that cannot be safely removed; ? Exclusion of patients with a history of severe physical illness, history of organic brain disease, and psychiatric disorders caused by thyroid or other physical illness; or comorbid severe physical, infectious, and immune system disorders; ? MRI exclusion criteria: patients with a history of cranial, thoracic, or abdominal surgery, and patients with pacemakers, artificial joints, or other metallic implants will be excluded from MRI scans. Subjects who agree to participate in the MRI portion of the study will be pre-screened for any potential metal debris in their body (especially the eye sockets) if they have any history of working with or participating in the use/deployment of metal.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Depression level;resting-state EEG;Functional connecttion of brain regions; | — |
Secondary
| Measure | Time frame |
|---|---|
| Suicidal ideation;Non-suicidal self-injury behavior;Clinical global impression scale;Insomnia Severity Index;Anxiety level; | — |
Countries
China
Contacts
Public ContactWang Jiesi; Liu Zhihua
Institute of Psychology, Chinese Academy of Science; Nanyang Fourth People's Hospital
Outcome results
None listed