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Clinical study of single intravenous injection of esmketamine combined with an oral antidepressant in the treatment of depressive disorde

Clinical study of single intravenous injection of esmketamine combined with an oral antidepressant in the treatment of depressive disorde

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200059660
Enrollment
Unknown
Registered
2022-05-06
Start date
2022-05-18
Completion date
Unknown
Last updated
2024-03-25

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

Conditions

Depression

Interventions

The experimental group:Use 0.25mg/kg ESM ketamine injection and physiological test Dilute saline injection to 50ml and drip intravenously for 40 minutes
The control group:Quetiapine fumarate (SRI Kang) was used as a synergist at a dose of 25-400 mg per day

Sponsors

Beijing Chaoyang Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: 1. Depression without psychotic symptoms is clinically diagnosed by a psychiatrist and meets the diagnostic criteria for depression without psychotic symptoms in DSM-IV; 2. The total score of the Montgomery-Ashelberg 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 the psychiatric hospital, and still require treatment at the study site; 3. Age 18-64 years old, gender unlimited; 4. Be able to understand the content of the scale and cooperate with the evaluation; 5. Sign the informed consent for the study and be able to follow up.

Exclusion criteria

Exclusion criteria: 1. Patients who have a history of alcohol dependence and acute poisoning in the past; Have a history of illegal drug abuse; Patients with psychotic disorder, bipolar disorder and obsessive-compulsive disorder; 2. At present, the main diagnosis is not depression; 3. Persons with high suicide risk at present: such as suicide attempts, who have attempted suicide recently; No family caregivers; 4. Female patients during pregnancy or lactation; 5. Do not use ketamine, Esketamine, or midazolam; 6. Patients who have used ECT or NMDA receptor antagonists in the last 6 months; 7. At present, there are patients with respiratory system diseases, hypertension, or other serious physical diseases that are difficult to control, such as severe cardiovascular diseases and hyperthyroidism, and patients with intracranial hypertension, intracerebral hemorrhage and glaucoma.

Design outcomes

Primary

MeasureTime frame
Montgomery-Asberg depression rating scale;Scale for Suicide Ideation;The Brief Psychiatric Rating Scale;Young manic rating scale;The Clinician Administered Dissociative States Scale;Quick Inventory of Depressive Symptomatology Self-Report;Frequency and Intensity of Side Effects Rating/Global Rating of Side Effects Burden, FISER/GRSEB;Patient Rated Inventory of Side Effects;

Countries

China

Contacts

Public ContactHu Yongdong

Beijing Chaoyang Hospital

huyongdong@bjcyh.com+86 18211085181

Outcome results

None listed

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