major depression disorder
Conditions
Interventions
SI Experimental group:esketamine
SI Midazolam controlled group:midazolam
TRD Experimental group:esketamine
TRD Midazolam controlled group:midazolam
Sponsors
The First Affiliated Hospital of Kunming Medical University
Eligibility
Sex/Gender
All
Age
13 Years to 18 Years
Inclusion criteria
Inclusion criteria: 1. Subjects must be psychiatric inpatients who met the diagnostic criteria for major depressive disorder in the Diagnostic and Statistical Manual of Mental Disorders, Edition 5 (DSM-5), had no psychotic features and were confirmed by Kiddie SADS interviews; 2. Subjects must be a boy or girl, aged 13 to 18 years, 13 inclusive, and accompanied by legal guardian; 3. Subjects must have vital signs, physical examination, and ancillary tests (including 12-lead electrocardiogram, hematology, blood biochemistry, and urine) within the normal reference range during the screening period; 4. Subjects must have a Child Depression Scale (CDSR-R) score greater than 40 or a Montgomery-Asperger Depression Scale (MADRS) score greater than or equal to 25 during the screening period; 5. Subjects must be adequately dosed with two or more antidepressants that have different mechanisms of action and do not respond throughout the course of treatment. Alternatively, subjects had to have an SI score no less than 4 on the Montgomery-Asperger Depression Scale (MADRS) or an SI score of 4 or 5 on the Columbia Suicide Severity Scale (C-SSRS) within the previous 24 hours; 6. Each Subject and his or her legal guardian must sign an informed consent form (ICF), indicate that he or she understands the purpose and procedure of the study and agrees to use the newly initiated oral antidepressant or to optimize the treatment with the currently used antidepressant and esketamine, and to be randomly assigned to different treatment groups; 7. Subjects must be willing and able to adhere to the prohibitions and restrictions specified in this protocol; 8. All subjects must agree to use an effective method of birth control.
Exclusion criteria
Exclusion criteria: 1. Subject has a current or prior DSM-5 diagnosis of bipolar or related disorders, psychotic disorder or MDD with psychosis. Subject has a current or prior DSM-5 diagnosis of cluster b personality disorder (e.g., borderline personality disorder, antisocial personality disorder, histrionic personality disorder, and narcissistic personality disorder). Subject has a current or prior DSM-5 diagnosis of intellectual disability, autism spectrum disorder (ASD), attention deficit and hyperactive disorder (ADHD), oppositional defiant disorder (ODD), conduct disorder or behavior disorder. Subject has a current or prior DSM-5 diagnosis of anorexia nervosa, obsessive compulsive disorder (OCD) or post-traumatic stress disorder (PTSD); 2. Subjects met the DSM-5 severity criteria for moderate or severe substance or alcohol use disorder (other than nicotine or caffeine) in the 6 months prior to screening. Subjects with a history of use related to ketamine, Phencyclidine (PCP), lysergic acid diethylamide (LSD), or 3, 4-methylenedioxy-methamphetamine (MDMA) hallucinogens; 3. Subjects with organic brain disease or mental retardation and other neurologic disorders affecting cognitive function; 4. Subjects with a history of epilepsy or seizures; 5. Subjects' contraindications to esketamine use were exclusive, especially as a diagnosis or precursor of clinically relevant cardiovascular disease (clinically significant or undertreated hypertension, cardiovascular disease such as hemodynamically significant valvular heart disease, or current or prior diagnosis of stroke or heart attack); 6. Subjects with clinically significant ECG abnormalities are exclusive. ECG abnormalities were defined as QTc intervals greater than or equal to 470ms 2 or 3 degrees atrioventricular block, or 1 degree atrioventricular block with PR interval greater than 200ms, left bundle branch block (LBBB) or right bundle branch block (RBBB) at screening or before the first dose of study medication. And a history of other risk factors (e.g., heart failure, hypokalemia, family history of long QT syndrome, or use of concomitant medications that prolong the QT/QTc interval) was identified at screening time; 7. Subjects have undergone major surgery (if general anesthesia is required) within 2 weeks prior to screening, or have not fully recovered from surgery, or have planned surgery during the period during which subjects are expected to participate in the study note: Participants who plan to undergo surgery under local anesthesia may participate; 8. Subjects are women who are pregnant or breastfeeding or planning to become pregnant during the study period (as confirmed by baseline laboratory testing) or within 3 months of taking the last dose of the study drug; Subjects were men who planned to have a child during the study period or within 3 months after taking the last dose of the study drug; 9. Subjects have a positive history of human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C antibody (anti-HCV), or other clinically active liver disease, or HIV, HBsAg or anti-HCV screening test; 10.Subject has known allergy, hypersensitivity, intolerance or contraindications to esketamine or its excipients (see product label in investigator's manual); 11.Subjects had a prior history of depressive symptoms that did not respond to esketamine or ketamine; 12.Subjects had no history of response to ECT in the current episode of depressive disorder; 13.Subjects
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Montgomery and Asberg Depression Rating Scale;Children’s Depression Rating Scale-Revised, CDRS-R; | — |
Secondary
| Measure | Time frame |
|---|---|
| Columbia-Suicide Severity Rating Scale, C-SSRS;suicide ideation scale, SSI; | — |
Countries
China
Contacts
Public ContactLu Jin
The First Affiliated Hospital of Kunming Medical University
Outcome results
None listed