treatment-resistant depression
Conditions
Interventions
Experimental group:Active stimulation 2 weeks(±3D) after implantation
Control group:Sham stimulation 2 weeks(±3D) after implantation,active stimulation 14 weeks(±3D) after implantation
Sponsors
Beijing Anding Hospital Capital Medical University;Xuanwu Hospital Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1) Meet the DSM-5 diagnostic criteria for depressive episodes; (2) Patients aged 18-65 years old, male or female; (3) 17-item Hamilton Depression Rating Scale (HAMD-17) score> 24 points; (4) the seizure lasted for at least 2 years; (5) At least two antidepressants with different mechanisms of action were used in this episode, and the treatment was ineffective with adequate amounts and full courses; (6) At least two synergists of antidepressant drugs (lithium, thyroid hormone, buspirone, benzodiazepines, selective ?-aminobutyric acid (GABA) agonist hypnotics and/or atypical antipsychotic drugs, etc.) have been ineffective for at least 4 weeks; (7) Take a stable dose of antidepressant medication for at least 4 weeks before screening; (8) The subject has a certain ability to understand and express, voluntarily participate and sign the informed consent form.
Exclusion criteria
Exclusion criteria: (1) Diagnosis of other psychiatric disorders in line with DSM-5; (2) patients with existing strong suicidal tendencies; (3) depressive episodes (delusions, hallucinations) with psychotic symptoms; (4) Previous manic or hypomanic episodes; (5) Pregnant and lactating women, and patients who cannot take appropriate contraceptive measures during the trial; (6) History of vagotomy in the left side of the neck; (7) Patients with neurological diseases, impaired motor, sensory or cognitive functions or patients who need to take drugs intermittently or for a long time (such as: Parkinson's disease, migraine, Huntington's disease, stroke, head injury); (8) Patients with insulin-dependent diabetes mellitus; (9) Patients with sleep apnea syndrome; (10) Those who have been diagnosed with coronary heart disease and have had angina pectoris, myocardial infarction or currently need to take medication (except those taking lipid-lowering drugs); (11) Those who have a pacemaker or defibrillator or other implantable instrument; (12) Patients with severe cardiopulmonary insufficiency; (13) Those who are currently participating in other clinical trials or have completed clinical trials but have not yet 3 months; (14) Those who are judged by the investigator to have poor compliance or are not suitable to participate in clinical trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The response rate of treatment-resistant depression meets the preset target value; | — |
Secondary
| Measure | Time frame |
|---|---|
| The difference in HAMD-17 score of experimental and control group relative to baseline;Complete response rate: Proportion of subjects with a total score of HAMD-17 <7 at the study endpoint;The difference in SDS score of every follow-up after stimulation relative to baseline;The difference in Q-LES-Q-SF score of every follow-up after stimulation relative to baseline;The difference in CGI-SI score of every follow-up after stimulation relative to baseline;The difference in CGI-GI score of every follow-up after stimulation relative to baseline; | — |
Countries
China
Contacts
Public ContactWang Gang;Zhang Xiaohua
Beijing Anding Hospital Capital Medical University;Xuanwu Hospital Capital Medical University
Outcome results
None listed