Depressive Disorder, Major, Depressive Disorder, Treatment-Resistant
Conditions
Keywords
treatment-resistant depression (TRD), major depressive disorder (MDD), sevoflurane
Brief summary
This study intends to carry out a prospective, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of subanesthetic sevoflurane for treatment-resistant depression.
Interventions
DRUGSevoflurane
Patients receive 1% sevoflurane and 30% oxygen for 1 hour.
DRUGPlacebo
Patients received 30% oxygen for 1 hour.
Sponsors
Shanghai Pudong New Area Mental Health Center
Shanghai First Maternity and Infant Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. age 18-65 years 2. meeting DSM-V criteria for major depressive disorder 3. a pretreatment score ≥17 on HDRS-17 4. meeting criteria for TRD, defined as having had at least two adequate dose-duration antidepressant medication failures in the current depressive episode. 5. current treatment drugs were stably used for at least 4 weeks
Exclusion criteria
1. MDD with psychosis, e.g., bipolar disorder, schizophrenia, schizoaffective disorder, obsessive-compulsive disorder, panic disorder, et al 2. Drug, tobacco or alcohol abuse 3. active suicidal intention 4. previous administration of NMDA receptor antagonists (e.g., ketamine) 5. previous (\<6 weeks prior) or ongoing treatment with electroconvulsive therapy (ECT) or transcranial magnetic stimulation (TMS) 6. pregnancy or breastfeeding 7. morbidly obese, BMI\>35kg/m2 8. other diseases that could interfere with the results
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rates of treatment responses in 17-item Hamilton Depression Rating Scale (HDRS-17) | 24 hours after the end of treatment | ≥50% HDRS-17 reduction in depressive symptoms |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rates of remissions in HDRS-17 | 2 hours, 24 hours, 7 days,14 days and 28 days after the end of treatment | HDRS-17 ≤7 points |
| Rates of treatment responses in Montgomery-Åsberg Depression Rating Scale (MADRS) | 2 hours, 24 hours, 7 days,14 days and 28 days after the end of treatment | ≥50% MADRS reduction in the baseline score |
| Rates of remissions in MADRS | 2 hours, 24 hours, 7 days,14 days and 28 days after the end of treatment | MADRS \<10 |
| The assessment of depression with self-rating scale | 2 hours, 24 hours, 7 days,14 days and 28 days after the end of treatment | The changes of score in Patient Health Questionnaire-9 (PHQ-9) |
| The assessment of anxiety by psychiatrist | 2 hours, 24 hours, 7 days,14 days and 28 days after the end of treatment | The changes of score in Hamilton Anxiety Rating Scale (HAMA) |
| Rates of treatment responses in HDRS-17 | 2 hours, 7 days,14 days and 28 days after the end of treatment | ≥50% HDRS-17 reduction in depressive symptoms |
| The assessment of improvement by psychiatrist | 2 hours, 24 hours, 7 days,14 days and 28 days after the end of treatment | The changes of score in Clinical Global Impression (CGI) |
| The assessment of improvement with self-rating scale | 2 hours, 24 hours, 7 days,14 days and 28 days after the end of treatment | The changes of score in Patient Global Impressions of Improvement (PGI-I) |
| The assessment of side effects with self-rating scale | 2 hours, 24 hours, 7 days,14 days and 28 days after the end of treatment | Including Patient Rated Inventory of Side Effects (PRISE) |
| Side effects of sevoflurane | up to 2 hours after the end of treatment | Including nausea, vomiting, headache, dizzy, hypotension, hypoxemia, carbon dioxide accumulation, et al |
| The assessment of anxiety with self-rating scale | 2 hours, 24 hours, 7 days,14 days and 28 days after the end of treatment | The changes of score in Generalized Anxiety Disorder Screener (GAD-7) |
Countries
China
Contacts
Primary ContactFuyi Shen, MD
Backup ContactZhiqiang Liu, MD
Outcome results
None listed