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Efficacy and safety of ketamine combined with antidepressants in major depression: a randomized controlled trial

Efficacy and safety of ketamine combined with antidepressants in major depression: a randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-INR-16008971
Enrollment
Unknown
Registered
2016-08-04
Start date
2016-09-01
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

depression disorder

Interventions

ketamine:single-dose i.v. ketamine (0.5mg/kg, 40 minutes)+ venlafaxine (150 mg/day, 4weeks)
control group:single-dose i.v. midazolam (0.045 mg/kg, 40 minutes) + venlafaxine (150 mg/day, 4weeks)

Sponsors

Beijing Chaoyang Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
25 Years to 64 Years

Inclusion criteria

Inclusion criteria: 1. Male and female aged 25-64 years; 2. diagnosis of non-psychotic major depression established by treating psychiatrists and confirmed by a checklist based on DSM-IV criteria at study entry; 3. total score of the 17-item Hamilton Rating Scale for Depression (HAMD)–Chinese version =24 and a score of the item 3 on suicide risk =1; 4. ability to communicate and provide written consent.

Exclusion criteria

Exclusion criteria: 1. lifetime history of drug/alcohol dependence, psychotic, bipolar or obsessive-compulsive disorders; 2. any Axis I disorder other than major depression judged to be the primary presenting problem; 3. history of inefficacy or intolerance to venlafaxine; 4. Pregnant or breast-feeding; 5. suicide attempt in the current episode; 6. major medical conditions contraindicating the use of ketamine or midazolam or venlafaxine; or 7. ECT or NMDA antagonist medications administered within the past 6 months.

Design outcomes

Primary

MeasureTime frame
Montgomery-Asberg depression rating scale;16-item Quick Inventory of Depressive Symptomatology Self-Report;The Columbia-Suicide Severity Rating Scale;

Countries

China

Contacts

Public ContactYongdong Hu

Beijing Chaoyang Hospital

huyongdong@bjcyh.com+86 18211085181

Outcome results

None listed

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