Investigating the Efficacy and Pharmacokinetic Profiles of Esketamine at Various Doses for Adolescents with Depression and Suicidal Ideation

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2500095496

Enrollment

Unknown

Registered

2025-01-08

Start date

2025-01-20

Completion date

Unknown

Last updated

2025-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adolescents with Depression and Suicidal Ideation

Interventions

Low-dose group:Esketamine hydrochloride, 0.25mg/kg, added to 50ml of 0.9% sodium chloride injection for intravenous infusion

Medium-dose group:Esketamine hydrochloride, 0.375mg/kg, diluted in 50ml of 0.9% sodium chloride injection for intravenous infusion

High-dose group:Esketamine hydrochloride, 0.50mg/kg, added to 50ml of 0.9% sodium chloride injection for intravenous infusion

Control group:Sodium chloride injection, 50ml of 0.9% solution for intravenous infusion

Eligibility

Sex/Gender

All

Age

13 Years to 17 Years

Inclusion criteria

Inclusion criteria: (1) Male and female patients, aged 13-17 years; (2) Inpatients diagnosed with Major Depressive Disorder according to the SCID-5, DSM-5 criteria; (3) A total score of 22 or above on the Montgomery-Åsberg Depression Rating Scale (MADRS); (4) Currently experiencing suicidal ideation, with either item 4 or item 5 on the Beck Scale for Suicide Ideation scoring 2 or more points; (5) Educational level of primary school or above; (6) The subject and their legal guardian understand the content of the study, are willing to participate in this research, and both the subject and the legal guardian have signed the written informed consent form.

Exclusion criteria

Exclusion criteria: 1. Diagnosed with other mental disorders according to DSM-5, including schizophrenia, bipolar disorder, substance-related and addictive disorders (excluding anxiety disorders), autism spectrum disorder, attention deficit hyperactivity disorder, etc.; 2. Patients with psychotic symptoms within the past month, with any of the positive symptom items (hallucinations, grandiosity, suspiciousness, unusual thought content) on the Brief Psychiatric Rating Scale (BPRS) scoring >1 point; 3. High suicide risk: Answering 'yes' to item 5 (active suicidal ideation with specific plans and intent) on the Columbia-Suicide Severity Rating Scale (C-SSRS) regarding suicidal ideation, and having suicidal behavior (defined as self-harm with intent to die) within the past two weeks; 4. History of epilepsy, brain trauma, or other neurological diseases, or clinically significant, uncontrolled cardiovascular, renal, hepatic, gastrointestinal, hematological, immune, endocrine, pulmonary diseases, or narrow-angle glaucoma, etc. (determined based on medical history, physical examination, or auxiliary examinations); 5. Allergic to ketamine or esketamine; 6. Positive urine toxicology screening at the time of screening or baseline (including urine cannabinoids, urine morphine, urine methamphetamine, urine ketamine, urine 3, 4-methylenedioxyamphetamine, urine cocaine).

Design outcomes

Primary

Measure	Time frame
C-SSRS;SSI;	—

Secondary

Measure	Time frame
MADRS;HAMA;SCID;CDI;BPRS;YMRS;CADSS;GAF;Cognitive function;MRI;	—

Countries

China

Contacts

Public ContactYanling Zhou

The Affiliated Brain Hospital of Guangzhou Medical University

zhouylivy@aliyun.com+86 20 8126 8113

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026