Major depressive disorder
Conditions
Interventions
0.4mg/kg esketamine group:0.4mg/kg esketamine injection
0.2mg/kg esketamine group:0.2mg/kg esketamine injection
Placebo group:0.2mg/kg saline injection
Sponsors
Chaohu Hospital, Anhui Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1) Male and female outpatients or inpatients between the ages of 18 and 65 years. (2) Single or recurrent episodes that meet the DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, 5th edition) criteria for the diagnosis of depressive disorders, without psychotic symptoms. (3) Patients with treatment-resistant depression who have used at least two antidepressant drugs with different mechanisms of action in the past and who have not been effective despite a full course of adequate treatment. (4) Total score of >= 20 on the 17-item Hamilton Depression Scale (HAMD-17) at screening and baseline visit. (5) A score of >= 2 on item 1 (depression) of the HAMD-17 scale at screening and baseline visit. (6) Clinical Global Impression Scale - Severity of Illness (CGI-S) score >= 4 at screening and baseline visit. (7) At screening and baseline, pregnancy test (urine) results were negative for women of childbearing age (e.g., women who have not undergone surgical sterilization or are less than 1 year postmenopausal). The male and female subjects of childbearing age agreed to use effective contraception for the entire study period and for at least 28 days after the last dose of the trial drug. (8) Subjects voluntarily participate in this trial and sign an informed consent form and are able to comply with planned visits, treatment plans, laboratory tests, and other study procedures.
Exclusion criteria
Exclusion criteria: (1) Allergic or known ketamine allergy. (2) Previous use of ketamine (e.g. under anaesthesia). (3) HAMD-17 scale scores in the baseline period with a reduction rate of >= 25% compared to the screening. (4) Apparent suicide attempts or behaviors with a score of >= 3 on item 3 (suicide) of the HAMD-17 scale. (5) Pregnant, breastfeeding women or women who do not use effective contraception or do not consent to the use of contraceptives at the most (6) Men and women of reproductive age who continue to use contraception within 28 days of the last dose. (7) Other DSM-IV-TR axis I diagnoses other than depressive disorders or treatment for that diagnosis (including current or previous diagnoses of anorexia nervosa or bulimia nervosa), or a previous diagnosis of distress within the past 2 years, are also excluded. (8) Authors of depression secondary to other mental or physical illnesses. (9) Persons with a history of seizures (except convulsions caused by high fever convulsions in children). (10) Electroconvulsive therapy (ECT) in the 3 months prior to screening or, in the investigator's judgment persons requiring ECT treatment before screening; persons who have received systemic psychotherapy (interpersonal, motivational, cognitive-behavioural) within 3 months before screening; persons who have received transcranial magnetic stimulation within 3 months before screening and phototherapy within 2 weeks before screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hamilton Depression Scale; | — |
Secondary
| Measure | Time frame |
|---|---|
| Montgomery-Asberg Depression Rating Scale;Clinical Global Impression;Hamilton Anxiety Scale; | — |
Countries
China
Contacts
Public ContactHuanzhong Liu
Chaohu Hospital, Anhui Medical University
Outcome results
None listed