Treatment resistant depression
Conditions
Sponsors
Chaohu Hospital, Anhui Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: A) Between 18 and 65 years of age, regardless of gender. B) meet the diagnostic criteria of DSM-5 (5th edition of Diagnostic and Statistical Manual of Mental Disorders) for depressive disorders and have no psychotic symptoms. C) patients with refractory depressive disorder who have used at least two different mechanisms of antidepressants in the past and are still ineffective after a sufficient course of treatment. D) the total score of Montgomery Depression scale >= 22 . E) at screening and baseline, the pregnancy test (urine) results of women of childbearing age were negative. Male and female subjects of childbearing age agreed to use effective contraception throughout the study and within at least 28 days after the last use of the trial drug. E) Primary school education and above. F) understand the content of the study, be willing to join the study and sign a written informed consent form.
Exclusion criteria
Exclusion criteria: A) Suffering from other major mental disorders that meet the diagnostic criteria of DSM-5, including organic mental disorders, alcohol dependence, drug dependence / abuse, schizophrenia, bipolar disorder, etc. B) people with allergies or known ketamine allergies. C) History of drug abuse, including previous recreational use of ketamine. D) hypertensive patients with poorly controlled blood pressure (SBP >= 140mmHg or DBP >= 90 mmHg during screening and baseline visits). E) according to the researchers, there is a clear risk of suicide or violence. F) the patient is currently accompanied by clear hallucinations, delusions and other psychiatric symptoms, and any item of the Brief Psychiatric Rating Scale (BPRS)(including hallucination, exaggeration, suspicion and unusual thinking content) is more than 1 score. G) positive for uremic screening at the time of screening or at baseline. H) those who previously had organic brain lesions or suffered severe external injuries to the brain. I) patients with severe cardiac, liver and renal insufficiency, metabolic diseases and other serious physical diseases. J) ECG (ECG) abnormalities with clinical significance during screening, including sinus bradycardia (resting heart rate = 450ms, female >= 470ms), history of congenital long QT syndrome, or risk of torsade de pointes due to family history of sudden death. K) Women during pregnancy or lactation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Montgomery Asberg Depression Rating Scale (MADRS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Hamilton Rating Scale for Depression (HAMD-17);Beck's Scale for Suicidal Ideation (SSI);Montreal Cognitive Assessment (MoCA);Hamilton Anxiety Rating Scale (HAMA);9-item Patient Health Questionnaire (PHQ-9);Clinical Global Impression Scale (CGI);treatment-emergent symptom side effect (TESS); | — |
Countries
China
Contacts
Public ContactZhang Kai
Chaohu Hospital, Anhui Medical University
Outcome results
None listed