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Single i.v.-ketamine augmentation of newly initiated venlafaxine hydrochloride for treatment-resistant depression: a randomized controlled trial

Single i.v.-ketamine augmentation of newly initiated venlafaxine hydrochloride for treatment-resistant depression: a randomized controlled trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800017848
Enrollment
Unknown
Registered
2018-08-17
Start date
2018-09-15
Completion date
Unknown
Last updated
2019-04-23

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

Conditions

depression disorder

Interventions

ketamine group:single-dose i.v. ketamine (0.5mg/kg, 40 minutes)+ venlafaxine (4 weeks, 75mg/day in the first week and 150mg/day in the other 3 weeks)
control group:single-dose i.v. midazolam (0.045mg/kg, 40 minutes)+ venlafaxine (4 weeks, 75mg/day in the first week and 150mg/day in the other 3 weeks)

Sponsors

Beijing Chaoyang Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
25 Years to 64 Years

Inclusion criteria

Inclusion criteria: (1) Diagnosis of non-psychotic major depression established by treating psychiatrists and confirmed by a checklist based on DSM-IV criteria at study entry; (2) Consistent with the criteria of treatment-resistant depression based on "Guidelines for the prevention and treatment of depression disorder in China (the second edition)"; (3) Total score of the 17-item Hamilton Rating Scale for Depression (HAMD)–Chinese version =17; (4) Male and female aged 25-64 years; (5) No antidepressants, antipsychotics, mood stabilizers, ECT and so on within two weeks; (6) Ability to understand the content of the scales and cooperate with assessment; (7) 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 hydrochloride; (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; (7) ECT or NMDA antagonist medications administered within the past 6 months; (8) Respiratory diseases, hypertension, or other serious physical diseases in the current episode.

Design outcomes

Primary

MeasureTime frame
Montgomery-Asberg depression rating scale;16-item Quick Inventory of Depressive Symptomatology Self-Report;

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