depressive disorder
Conditions
Interventions
L-leucine group:L-leucine and high-frequency iTBS antidepressant treatment
Sponsors
Linyi Mental Health Center (Linyi Fourth People's Hospital)
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1. Age 18-55 years (inclusive); 2. Evaluated by a psychiatrist according to the Brief International Neuropsychiatric Interview (MINI-C), and all subjects met the diagnostic criteria for depressive episodes in ICD-11; 3. Male or female, right-handed; 4. There were no contraindications to transcranial magnetic stimulation on EEG; 5. No more than 1 week of antidepressant medication prior to randomisation or had been continuously taking antidepressant medication for more than 2 weeks without obvious effect (the interval between the start of the current medication and the end of the last medication must be more than 2 months)or no antidepressant and other psychotropic medication use; if there is any psychotherapy prior to enrolment, they must have been in a stable therapeutic state for at least 3 months prior to entry into the study and there is no expected change in the frequency of treatment or the focus of treatment during the study period of the psychotherapeutic regimen, and those without psychotherapy no systemic psychotherapy after enrolment; if MECT or TMS treatment was available prior to enrolment, it has been completed for at least more than 3 months; 6. Score >=17 on the 17-item Hamilton Depression Scale; score <=8 on the Young's Mania Rating Scale; 7. Passing the TMS Adult Safety Screening (TASS) questionnaire; 8. Patients gave informed consent and participated in the study voluntarily.
Exclusion criteria
Exclusion criteria: 1. Drug allergy; 2. 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; 3. Persons at high risk of causing harm to themselves or others (Physician's Assessment of Individual Suicide Risk Scale); 4. Currently pregnant, breastfeeding or planning to become pregnant; 5. 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; 6. Previous MECT or ineffective ECT treatment within the previous 6 months; currently (or within the past 4 weeks) taking lorazepam or any other benzodiazepine; 7. Patients who cannot tolerate conventional iTBS treatment; 8. 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; 9. 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; 10. 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; | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical global impression;Self-assessment of depression level;Self-assessment of Anxiety level ;Insomnia severity index;Suicidal ideation;Level of anhedonia;Illness perception;Stress;Loneliness;Hopelessness;Rumination;Daily depressive symptoms;Executive function; | — |
Countries
China
Contacts
Public ContactGao Lan
Institute of Psychology, Chinese Academy of Science; Linyi Mental Health Center (Linyi Fourth People's Hospital)
Outcome results
None listed