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A clinical study of a single intravenous injection of esketamine combined with an oral antidepressant in improving cognitive function and social function in depressive disorders

A clinical study of a single intravenous injection of esketamine combined with an oral antidepressant in improving cognitive function and social function in depressive disorders

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100054287
Enrollment
Unknown
Registered
2021-12-13
Start date
2022-01-01
Completion date
Unknown
Last updated
2022-11-14

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

Conditions

Depression

Interventions

Sponsors

Beijing Chaoyang Hospital Affiliated to Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: 1. Clinically diagnosed as depressive disorder without psychotic symptoms by a psychiatrist practitioner, and meet the diagnostic criteria for depressive disorder without psychotic symptoms in the Diagnostic and Statistical Manual of Mental Disorders IV (DSM-IV); 2. The total score of the Montgomery-Asherberg Depression Rating Scale (MARDS) is >=22 points, and the suicide item score is >=1 point, but they do not accept the recommendation of referral to a psychiatric hospital and still require treatment at the study site; 3. Aged 18-64 years, gender is not limited; 4. Be able to understand the content of the scale and cooperate with the assessment; 5. Sign the informed consent for the study and be able to follow up.

Exclusion criteria

Exclusion criteria: 1. Patients with previous history of alcohol and drug dependence and acute poisoning; history of illegal drug abuse; patients with psychotic disorder, bipolar disorder, and obsessive-compulsive disorder; 2. The current main diagnosis is not patients with depressive disorder; 3. Those who currently have a high risk of suicide: such as suicide attempts, recent suicide attempts; and no family caregivers; 4. Pregnant or lactating patients; 5. The use of ketamine, esketamine, or midazolam is contraindicated; 6. Patients who have used ECT or NMDA receptor antagonists within the past 6 months; 7. Patients with respiratory diseases, hypertension, or other serious physical diseases that are difficult to control, such as: patients with severe cardiovascular disease and hyperthyroidism, increased intracranial pressure, cerebral hemorrhage, and glaucoma.

Design outcomes

Primary

MeasureTime frame
cognitive function;social function;

Secondary

MeasureTime frame
depressive symptom;

Countries

China

Contacts

Public ContactMa Ke

Beijing Chaoyang Hospital Affiliated to Capital Medical University

drmark2021@163.com+86 15010357155

Outcome results

None listed

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