Major Depressive Disorder
Conditions
Interventions
treatment-resistant depression:Vagus Nerve Stimulation
Sponsors
Beijing Anding Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1) 2 physicians attending the system were clinically evaluated, which met the DSM-IV criteria for the diagnosis of major depressive disorder; 2) outpatients aged 18-65 years, both male and female; 3) screening and baseline 17 Hamilton Depression Scale (HAMD-17) score >24 points; 4) had experienced 4 episodes of depression in the past, and this episode lasted at least 1 year without remission; 5) Antidepressants that have been treated with two or more existing mechanisms of action are adequate and are not effective if they are treated for a full duration (up to the recommended dosage for the drug instruction, for more than 6 weeks); 6) This episode uses at least two or more antidepressants as synergists (eg lithium, thyroid hormone, buspirone, benzodiazepines, selective ?-aminobutyric acid (GABA) Agonist hypnotics or atypical antipsychotics, etc.) are ineffective for at least 4 weeks; 7) This episode has received 6 or more MECT treatment failure; 8) The episode was accepted at least once a week for at least six months without effective psychotherapy; 9) take a stable dose of antidepressant at least 6 weeks before surgery; 10) Signed consent forms by Patients legal guardian. ;Inclusion criteria: 1) 2 physicians attending the system were clinically evaluated, which met the DSM-IV criteria for the diagnosis of major depressive disorder; 2) outpatients aged 18-65 years, both male and female; 3) screening and baseline 17 Hamilton Depression Scale (HAMD-17) score >24 points; 4) had experienced 4 episodes of depression in the past, and this episode lasted at least 1 year without remission; 5) Antidepressants that have been treated with two or more existing mechanisms of action are adequate and are not effective if they are treated for a full duration (up to the recommended dosage for the drug instruction, for more than 6 weeks); 6) This episode uses at least two or more antidepressants as synergists (eg lithium, thyroid hormone, buspirone, benzodiazepines, selective ?-aminobutyric acid (GABA) Agonist hypnotics or atypical antipsychotics, etc.) are ineffective for at least 4 weeks; 7) This episode has received 6 or more MECT treatment failure; 8) The episode was accepted at least once a week for at least six months without effective psychotherapy; 9) take a stable dose of antidepressant at least 6 weeks before surgery; 10) Signed consent forms by Patients legal guardian.
Exclusion criteria
Exclusion criteria: 1) 2 physicians attending the system were evaluated clinically, which were in accordance with DSM-IV diagnosis of other mental disorders; 2) patients with previous suicidal behaviors or those with strong suicidal tendencies; 3) depressive episodes accompanied by psychotic symptoms (delusions, hallucinations); 4) with a history of mania or hypomania; 5) Diagnosis of alcohol or substance abuse and dependence in accordance with DSM-IV diagnostic criteria within 1 year prior to screening; 6) Pregnant and lactating women who can not take appropriate contraception during the trial; 7) Those with previous major physical diseases; 8) a history of vagotomy in the left neck; 9) Patients with neurological disorders who have impaired motor, sensory or cognitive function, or need intermittent or long-term use of drugs (eg Parkinson's disease, migraine, Huntington's disease, stroke, traumatic brain injury); 10) insulin-dependent diabetes mellitus; 11) patients with respiratory sleep apnea syndrome; 12) patients who are undergoing or are expected to undergo intensive electromagnetic therapy or examination during the observation period; 13) diagnosed coronary heart disease and previous angina, myocardial infarction or the need to take medication (except taking lipid-lowering drugs); 14) have pacemakers or defibrillators or other implanted instruments; 15) current use of anticoagulants; 16) Serious cardiopulmonary insufficiency.;Exclusion criteria: 1) 2 physicians attending the system were evaluated clinically, which were in accordance with DSM-IV diagnosis of other mental disorders; 2) patients with previous suicidal behaviors or those with strong suicidal tendencies; 3) depressive episodes accompanied by psychotic symptoms (delusions, hallucinations); 4) with a history of mania or hypomania; 5) Diagnosis of alcohol or substance abuse and dependence in accordance with DSM-IV diagnostic criteria within 1 year prior to screening; 6) Pregnant and lactating women who can not take appropriate contraception during the trial; 7) Those with previous major physical diseases; 8) a history of vagotomy in the left neck; 9) Patients with neurological disorders who have impaired motor, sensory or cognitive function, or need intermittent or long-term use of drugs (eg Parkinson's disease, migraine, Huntington's disease, stroke, traumatic brain injury); 10) insulin-dependent diabetes mellitus; 11) patients with respiratory sleep apnea syndrome; 12) patients who are undergoing or are expected to undergo intensive electromagnetic therapy or examination during the observation period; 13) diagnosed coronary heart disease and previous angina, myocardial infarction or the need to take medication (except taking lipid-lowering drugs); 14) have pacemakers or defibrillators or other implanted instruments; 15) current use of anticoagulants; 16) Serious cardiopulmonary insufficiency.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction rate of HAMD-17 total score;;Reduction rate of HAMD-17 total score; | — |
Countries
China
Contacts
Public ContactGang Wang;Gang Wang ;
Beijing Anding Hospital, Capital Medical University;Beijing Anding Hospital, Capital Medical University
Outcome results
None listed