refractory depression
Conditions
Sponsors
Beijing Anding Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1) Meet the diagnosis of DSM-5 major depressive disorder (MDE), first or recurrent, without psychotic symptoms; 2) Unlimited gender, age 18-65 years old; 3) Total episode duration =2 years, or at least 3 depressive episodes in the past, the current episode duration =1 year; 4) Refractory degree (must meet the following 4 conditions at the same time): a. Ineffective treatment with at least 2 antidepressants with different mechanisms of action (effective therapeutic dose or adequate therapeutic dose =6 weeks); b. Ineffective or intolerant to at least 2 different antidepressant combination therapy or augmentation treatment strategies (atypical antipsychotics, lithium salts, thyroxine, 5-HT1A receptor partial agonists, anti-epileptic drugs, etc.) for at least 4 weeks; c. Ineffective systematic psychotherapy, or the patient does not accept psychotherapy; d. Ineffective adequate MECT treatment, or the patient refuses, is not suitable for, or is intolerant to MECT treatment. 5) Hamilton Depression Rating Scale-17 (HAMD-17) score = 21 points at screening and baseline; 6) Global Assessment of Functioning (GAF) score = 50 at screening and baseline; 7) Not currently taking medication or taking antidepressants at an effective therapeutic dose or adequate therapeutic dose for at least 4 weeks before screening; 8) The patient and legal guardian agree to receive implantable neurostimulation system treatment and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1) Meet the diagnosis of other mental illnesses in DSM-5; 2) Diagnose alcohol or drug (excluding tobacco) abuse and dependence within 6 months before screening; 3) The researcher judges that the laboratory test has obvious clinical significance. The subordinate indicators exceed the following standards: ALT or AST laboratory test value is higher than 3 times the upper limit of normal value; total bilirubin value is higher than 1.5 times the upper limit of normal value; 2 or more of the 5 thyroid function indicators are higher than 1.5 times the upper limit of normal value or lower than 0.5 times the lower limit of normal value, syphilis antibody, human immunodeficiency virus antibody and other infectious disease screening is positive, the electrocardiogram during the screening period is abnormal and has obvious clinical significance, such as QTc interval =450ms for men and QTc interval =470ms for women, and the researcher believes that it is not suitable for selection; 4) Patients with strong suicidal tendencies; 5) Those with a history of active epilepsy, cranial nervous system injury, stereotactic nerve nucleus damage 6) Those who are judged by the researchers to have abnormal blood pressure and blood sugar that are difficult to control, who are taking anticoagulants before surgery or have clinical bleeding tendency, who have implanted cochlear implants, pacemakers, defibrillators, unilateral or bilateral similar products, or have undergone other surgical operations that the researchers believe may affect this trial within six months, or have other serious physical diseases and other contraindications to neurosurgery; 7) Those with poor compliance and unable to complete regular follow-up; 8) Women who are pregnant or preparing to become pregnant or breastfeeding; 9) Those who are participating in other clinical trials or have participated in clinical trials within the past three months (except registration studies); 10) Those who the researchers believe are not suitable for participating in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The reduction rate of the total score of Hamilton Depression Rating Scale (HAMD-17) compared with the baseline; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in Hamilton Depression Rating Scale (HAMD-17) scores compared with baseline;Changes in Hamilton Anxiety Rating Scale (HAMA-14) scores compared with baseline;Changes in the Montgomery Depression Rating Scale (MADRS) score compared with the baseline;Changes in Columbia-Suicide Severity Rating Scale (C-SSRS) scores compared with baseline;Changes in the Young's Mania Rating Scale (YMRS) score compared with the baseline;The change in the score of the General Assessment of Function (GAF) scale compared with the baseline;Changes in the SF-36 score compared with the baseline;Changes in the World Health Organization Quality of Life Brief Form (WHOQOL-BREF) scores compared with the baseline;Changes in Patient Health Questionnaire (PHQ-9) scores compared with baseline at 30, 90, and 180 days after booting;Changes in the Quick Inventory of Depressive Symptomatology-Self-Report16 scores compared with the baseline at the end of the 30th, 90th, and 180th days after booting;Changes in the Generalized Anxiexy Disorde-7 score compared with the baseline at the end of the 30th, 90th, and 180th days after booting; | — |
Countries
China
Contacts
Public ContactGang Wang
Beijing Anding Hospital, Capital Medical University
Outcome results
None listed