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Clinical study of esketamine in optimizing the treatment of depressive sleep disorders

Clinical study of esketamine in optimizing the treatment of depressive sleep disorders

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400081021
Enrollment
Unknown
Registered
2024-02-20
Start date
2023-11-01
Completion date
Unknown
Last updated
2024-02-26

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

Conditions

Depressive sleep disorder

Interventions

Control group:Dexmedetomidine treatment
Experimental Group 1:0.2mg/kg Esketamine in combination with dexmedetomidine therapy
Experimental Group 2:0.25mg/kg Esketamine in combination with dexmedetomidine therapy
Experimental Group 3:0.3mg/kg Esketamine in combination with dexmedetomidine therapy

Sponsors

Department of Anesthesiology, Changzhou Second People's Hosptial Affiliated to Nanjing Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
16 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1.Conform to the ' ICD-10 mental and behavioral disorders classification ' F51.0 non-organic insomnia diagnostic criteria ; 2.PSQI score = 16 ; 3.MADRS score 22-35 points ; 4.Patients who did not take any antipsychotics and sedative hypnotic drugs in the past week.

Exclusion criteria

Exclusion criteria: 1.Patients who have previously been diagnosed with bipolar disorder, narcolepsy or sleep apnea, or sleep disorders caused by the psychological effects of other organic diseases such as epilepsy, various chronic diseases, pain, excessive drinking or taking special drugs. 2.Patients with a history of aneurysmal vascular disease, arteriovenous malformation or cerebral hemorrhage. 3.Cardiac conduction dysfunction ; patients with severe heart, liver, lung and kidney dysfunction. 4.Pregnant and lactating women. 5.Patients known to have a history of allergy to the drug in this study.

Design outcomes

Primary

MeasureTime frame
deep sleep ratio;light sleep ratio;rapid eye movement ratio;quality of sleep;PSQI sleep score;depression score;

Secondary

MeasureTime frame
Serum indicators;

Countries

China

Contacts

Public ContactZhouquan Wu

The Second People's Hospital of Changzhou, Jiangsu

151897127@qq.com+86 138 6102 3270

Outcome results

None listed

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