Major depressive disorder
Conditions
Interventions
Ketamine hydrochloride group:None
Sponsors
Beijing An Ding Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 1.Agree to be included in the "A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of (R)-Ketamine Hydrochloride Nasal Spray in Patients with Treatment-Resistant Depression"; 2.Male and female participants aged between 18-64 years (including threshold) at the time of signing the informed consent form; 3.When screening, it is necessary to meet the diagnostic criteria for depression in the Diagnostic and Statistical Manual of Mental Disorders -5th edition (DSM-5), for patients with recurrent or single episodes of depression (if it is a single episode, the duration must be >= 3 months), and to combine clinical evaluation and confirmation through the Concise International Psychiatric Interview (MINI); 4.During the current depressive episode, the subjects showed poor or ineffective treatment with at least two oral antidepressants after sufficient treatment. One of them (excluding monoamine oxidase inhibitors) may be an oral antidepressant currently in use (estimated improvement = 28 points, and the Clinical General Impression Disease Severity Scale (CGI-S) was >= 4 points; 6.Based on the results of clinical laboratory tests, physical examinations, vital signs, etc. conducted during the screening period, if there are situations that exceed the normal reference range, subjects can only be enrolled if the researcher determines that the abnormal value has no clinical significance or meets the disease characteristics of the study population; 7.The subjects agreed to continue taking a fixed dose of antidepressants orally as basic treatment throughout the entire study period until the end of the study; 8.Those who voluntarily participate and sign the informed consent form after understanding the purpose, content, process, and potential risks of the experiment; 9.Able to communicate well with researchers, willing and able to comply with the lifestyle restrictions specified in the protocol, and cooperate to complete the experimental process;
Exclusion criteria
Exclusion criteria: 1.The subject is currently diagnosed with the following disorders: schizophrenia and other psychiatric disorders, bipolar or related disorders, post-traumatic stress disorder, obsessive-compulsive disorder (primary), intellectual disability, borderline personality disorder, antisocial personality disorder, performative personality disorder, and narcissistic personality disorder (all based on DSM-5 criteria); Or there may be any other mental or neurological disorders or symptoms caused by clinical conditions; 2.The current depressive episode period of the subject lasts for >= 2 years, during which symptoms persist and there is no significant improvement after standardized treatment (estimated improvement= 6 times within 4 weeks); 5.According to the researchers' assessment, the subjects have a high risk of suicide, or: the answer to the "actual attempt" item in the "suicidal behavior" section of C-SSSRS (in the past year) is "yes", or the score of item 10 (suicidal ideation) in MADRS is >= 5 points; 6.Researchers have identified current or past medical histories of the following diseases that affect clinical trials, including but not limited to central nervous system, cardiovascular system (including unstable coronary artery disease and congestive heart failure, pathological tachycardia, and recent myocardial infarction), urinary system (including interstitial cystitis and Hunner's ulcer), respiratory system, digestive system, endocrine system (including uncontrolled thyroid dysfunction), hematological system, rheumatic immune or metabolic diseases (including severe dehydration/hypovolemia), etc; 7.History of convulsive seizures, except for febrile seizures in childhood; 8.Patients who are not suitable for nasal spray administration (including but not limited to nasal structural abnormalities, visible ulcers in the nasal cavity, etc.); 9.Laboratory examination abnormalities: ALT and/or AST levels >= 3 times the upper limit of normal (ULN); Blood urea nitrogen (BUN) or urea (Urea) >= 1.5 times ULN; Creatinine (Cr) >= 1.2 times ULN, or other clinically significant levels determined by researchers; (When potential subjects experience indicators exceeding the range during screening, a repeat screening is allowed without adding additional drug control.); 10.Those with poorly controlled thyroid diseases or abnormal thyroid stimulating hormone (TSH) test results determined by researchers to be clinically significant; 11.The subjects received stable doses of antihypertensive drugs during screening, but their hypertension was still not effectively controlled (SBP >= 140mmHg or DBP >= 90mmHg); Or have a history of hypertensive crisis in the past; (Potential subjects with abnormal blood pressure values during screening can repeat the process after relaxing for 5-10 minutes); 12.The subjects have significant electrocardiographic abnormalities, including but not limited to: Friericia corrected QT interval (QTcF)>450ms (males), or QTcF>470ms (females); 13.The subjects met the DSM-5 criteria for moderate or severe substance or alcohol
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Whole brain 3D high-resolution structural image; | — |
Primary
| Measure | Time frame |
|---|---|
| Resting state functional magnetic resonance imaging;Natural stimulus task-state functional magnetic resonance imaging;Unconscious emotional facial expression task state EEG;Arterial spin labeling imaging;Dissociation and other subjective experiences self-reported task state EEG signals;Emotional and cognitive control task state EEG; | — |
Countries
China
Contacts
Public ContactGang Wang
Beijing An Ding Hospital, Capital Medical University
Outcome results
None listed