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Efficacy of chlorpromazine as a adjunctive therapy for esketamine on major depression: a randomized controlled trial

Efficacy of chlorpromazine as a adjunctive therapy for esketamine on major depression

Status
Unknown
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400084824
Enrollment
Unknown
Registered
2024-05-24
Start date
2024-06-01
Completion date
Unknown
Last updated
2024-09-09

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

Conditions

depression

Interventions

control:midazolam+dexmedetomidine
treatment:chlorpromazine+dexmedetomidine

Sponsors

The Affiliated Hospital of Shandong Second Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 65 Years

Inclusion criteria

Inclusion criteria: 1.Age5. 4.Patients who do not respond to traditional therapeutic drugs and electroconvulsive. 5.The patients had at least three months with a complaint of depressive mood, anhedonia, somatization, cognitive disturbance, and sleep disorder. 6.Plan to accept therapy with esketamine and dexmedetomidine.

Exclusion criteria

Exclusion criteria: 1.Refuse to participate the study. 2. Contraindication of Dex and esketamine. 3.Preoperative history of schizophrenia, epilepsy, Parkinson’s disease, or myasthenia gravis. 4.Patients with other types of sleep disorders such as sleep apnea, restless legs syndrome, etc. 5.Inability to communicate in the preoperative period because ofcoma, profound dementia, language barrier. 6. Patents with pathological sinus syndrome, severe sinus bradycardia (heart rate<50 beats/min), atrioventricular block of degree II or above, and no implanted pacemaker. 7.Severe hepatic dysfunction (ChildePugh Class C), required preoperative dialysis or expected lifetime < 24 hours. 8.Received treatment with dexmedetomidine or ketamine. 9.Allergy to dexmedetomidine or ketamine.

Design outcomes

Primary

MeasureTime frame
Proportions of responders and remission (PHQ-9 reduction>50% or PHQ-9<5);

Secondary

MeasureTime frame
Proportions of remission (PHQ-9<5);Score of anxiety, depression and suicide;Score of sleep;Use of anti-psychotic drugs;Readmission;Revisit to psychiatric clinic;Esketamine associated adverse events ;

Countries

China

Contacts

Public ContactJianxiong An

The Affiliated Hospital of Shandong Second Medical University (formerly The Affiliated Hospital of Weifang Medical University)

anjianxiong@yeah.net+86 138 0128 1750

Outcome results

None listed

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