A Study to evaluate the efficacy and safety of Esketamine combined with oral antidepressants in the treatment of major depressive disorder with suicidal ideation

Conditions

Major depressive disorder with suicidal ideation

Lan X, Wang C, Zhang F, Liu H, Li W, Ye Y, Hu Z, Mai S, Ning Y, Zhou Y.

2023-09-1413 citations

Effect of Repeated Intravenous Esketamine on Adolescents With Major Depressive Disorder and Suicidal Ideation: A Randomized Active-Placebo-Controlled Trial.

Zhou Y, Lan X, Wang C, Zhang F, Liu H, Fu L, Li W, Ye Y, Hu Z, Chao Z, Ning Y.

2023-07-0424 citations

10.1016/j.jaac.2023.05.031

Efficacy of repeated intravenous esketamine in adolescents with anxious versus non-anxious depression

Xiaofeng Lan, Chengyu Wang, Fan Zhang, Haiyan Liu, Ling Fu et al. (11 authors)

General Psychiatry2023-06-0111 citations

10.1136/gpsych-2023-101007

The efficacy and safety of esketamine in the treatment of major depressive disorder with suicidal ideation: study protocol for a randomized controlled trial.

Liu H, Lan X, Wang C, Zhang F, Fu L, Li W, Ye Y, Hu Z, Chao Z, Ning Y, Zhou Y.

2022-11-306 citations

10.1186/s12888-022-04388-y

Interventions

adolescent experimental group:Esketamine (0.25mg/kg)

adolescent control group:Midazolam (0.02mg/kg)

adult experimental group:Esketamine (0.25mg/kg)

adult control group:Midazolam (0.02 mg/kg)

Eligibility

Sex/Gender

All

Age

13 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1) Male and female inpatients; (2) Aged 13-65 years, adolescent cohort 13 years=age<18 years,adult cohort 18 years=age=65 years ; (3) Diagnosed with major depressive disorder by screening scid-5 and dsm-5; (4) Patients with 17 or more HAMD-17 scores; (5) Patients with current suicidal ideation for = 3 months as measured by a clinician-rated Columbia suicide severity rating scale (C-SSRS) ideation score = 1 and a self-report Beck Scale for Suicide Ideation (SSI)-first 5 items score = 2 and at screening; (6) Subjects with primary school education or above; (7) The subjects who understand the content of the study are willing to join the study and sign the written informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with other mental disorders diagnosed by dsm-5, including schizophrenia, bipolar disorder, substance related disorder and addiction disorder (except anxiety disorder); 2. Patients with psychotic symptoms in recent 3 months who scored more than 1 in any of the positive symptom items of BPRS (hallucination, exaggeration, suspicion and unusual thinking content); 3. Patients with high suicide risk: had suicidal behavior (defined as self injuring behavior with intention to die) in the past six months, or the researchers judged that they had high suicide risk; 4. Patients with history of nervous system diseases such as epilepsy and dementia, or patients with clinically significant and uncontrolled cardiovascular, kidney, liver, gastrointestinal, blood, immune, endocrine, pulmonary diseases or narrow angle glaucoma (judged according to history, physical examination or auxiliary examination); 5. Patients with allergic reaction to ketamine; 6. Patients with positive urine toxicology screening at screening or baseline; 7. Subjects with positive serum / urine pregnancy test or breast-feeding at the time of screening, or planned to be pregnant during the study.

Design outcomes

Primary

Measure	Time frame
Columbia suicide severity rating scale;	—

Secondary

Measure	Time frame
Montgomery–?sberg Depression Rating Scale;Beck Scale for Suicide Ideation;Hamilton Depression Rating Scale items 10, 11;	—

Countries

China

Contacts

Public ContactYuping Ning

Brain Hospital Affiliated to Guangzhou Medical University

ningjeny@126.com+86 20-81570720

Outcome results

None listed