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Study on the Efficacy and Safety of Esketamine Hydrochloride Nasal Spray Combined with Antidepressants in Rapidly Improving Symptoms in Patients with Depression

Study on the Efficacy and Safety of Esketamine Hydrochloride Nasal Spray Combined with Antidepressants in Rapidly Improving Symptoms in Patients with Depression

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600116233
Enrollment
Unknown
Registered
2026-01-07
Start date
2026-01-10
Completion date
Unknown
Last updated
2026-01-12

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

Conditions

Adult depression patients with suicidal ideation or behavior

Interventions

Group of patients with SSRIs antidepressant:Oral SSRI antidepressants (such as sertraline, fluoxetine, etc.)
A group of patients were treated with Esketamine nasal spray combined with SSRIs antidepressant:Oral SSRI antidepressants (such as sertraline, fluoxetine, etc.) in combination with esketamine hydrochl

Sponsors

The First Affiliated Hospital of Xi'an Jiaotong University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Depressive disorder patients who meet the diagnostic criteria of ICD-10, aged 18–65 years old; 2. MADRS score total >= 20 points, with suicide item score >= 2 points; 3. Capable of understanding and complying with research requirements; 4. Capable of writing; normal audio-visual ability; 5. Capable of signing informed consent and willing to participate in research.

Exclusion criteria

Exclusion criteria: 1.Brain trauma, cerebrovascular disease, epilepsy, spasms, or intellectual disabilities; 2.Individuals with cataracts, other ophthalmic diseases, or hearing impairments; 3.Subjects with physical diseases diagnosed with ICD-10 have liver function aspartate aminotransferase>40 U/L, alanine aminotransferase>40 U/L, renal function estimated glomerular filtration rate440 ms, Female:>460 ms. 4.Based on medical history, it is determined that the patient meets the criteria for substance abuse or dependence in ICD-10 diagnosis. 5.Any other situation that researchers consider unsuitable for inclusion.

Design outcomes

Primary

MeasureTime frame
Change in MADRS total score (from baseline to Day 3 of enrollment);Change in BSS score (from baseline to Day 3 of enrollment);MADRS score reduction rate (%);BSS score reduction rate (%);

Secondary

MeasureTime frame
Clinical response rate: Proportion of patients with a >=50% reduction from baseline in MADRS total score;Clinical remission rate: Proportion of patients with MADRS total score <=10;

Countries

China

Contacts

Public ContactJiang Wenhui

The First Affiliated Hospital of Xi'an Jiaotong University

wenhuij2008@sina.com+86 29 85324575

Outcome results

None listed

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