Clinical TrialDepressive DisordersSuicidalityEsketamineNot yet recruiting

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

This parallel Phase 4 interventional trial in China (n=180) is evaluating the efficacy and pharmacokinetic profiles of esketamine at different doses in adolescents aged 13 to 17 years with depression and suicidal ideation. Participants are allocated to one of three intravenous esketamine groups or a saline control group: low-dose esketamine hydrochloride 0.25 mg/kg, medium-dose 0.375 mg/kg, or high-dose 0.50 mg/kg, each diluted in 50 ml of 0.9% sodium chloride injection and administered by intravenous infusion, versus 50 ml of 0.9% sodium chloride injection alone. The primary outcomes are suicide risk and ideation, measured using the Columbia Suicide Severity Rating Scale (C-SSRS) and the Scale for Suicide Ideation (SSI), with assessment timepoints not specified in the available record. Secondary outcomes include depressive symptoms, anxiety, diagnostic status, cognitive and global functioning, dissociative and manic symptoms, and neuroimaging, assessed using instruments such as the MADRS, HAMA, SCID, CDI, BPRS, YMRS, CADSS, GAF, cognitive testing, and MRI. The study is sponsored by the Affiliated Brain Hospital of Guangzhou Medical University.

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Target Enrollment
Not specified
Study Type
Phase IV interventional
Design
Non-randomized

Study Arms & Interventions

Experimental

experimental

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;

Interventions

  • Esketamine

    Extracted from ChiCTR intervention description

Participants

Ages
13 – 17
Sexes
Male & Female

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).

Study Details

Study Team

Locations

China