Clinical TrialTreatment-Resistant Depression (TRD)KetamineCompleted

An exploratory study of antidepressant treatment using ketamine for treatment-resistant depression

An open-label, single-arm study at four Chinese hospitals investigating repeated subanesthetic ketamine infusions (0.5 mg/kg IV over 40 min, 6 sessions thrice weekly for 2 weeks) in patients with treatment-resistant depression. Registered prospectively in 2017 and funded by China’s National Key R&D Programme for Precision Medicine.

Target Enrollment
900 participants
Study Type
Phase NA interventional
Design
Non-randomized

Study Arms & Interventions

Repeated ketamine infusions

experimental

Six IV infusions of subanesthetic ketamine (0.5 mg/kg over 40 min) administered thrice weekly for two weeks. No control or placebo arm.

Interventions

  • Ketamine0.5 mg/kg
    via IV• Thrice weekly for 2 weeks• 6 doses total

    Each infusion delivered over 40 minutes. Assessments at baseline and day 13 (after sixth infusion).

Participants

Ages
18 – 65
Sexes
Male & Female

Inclusion Criteria

  • Adults aged 18–65; DSM-5 diagnosis of depression meeting TRD criteria (ineffective response to ≥2 antidepressants at sufficient dose [≥2/3 of maximum recommended dose, equivalent to imipramine 150–200 mg/d] and sufficient duration [≥4 weeks; ≥8 weeks for chronic depression], defined as HAMD score-reducing rate <30%); HAMD-17 score ≥17 at enrolment; junior middle school education or above; willing to participate and sign informed consent.

Exclusion Criteria

  • Other major psychiatric disorders per DSM-5 (organic mental disorders, alcohol dependence, drug dependence/abuse, schizophrenia, bipolar disorder); serious or unstable somatic conditions (diabetes, thyroid disease, hypertension, heart disease, narrow-angle glaucoma); history of neurological disease (epilepsy, dementia); positive urine toxicology screening; pregnancy, lactation, or planned pregnancy; inability or unwillingness to comply with treatment.

Study Details

Locations

The Affiliated Brain Hospital of Guangzhou Medical University (Guangzhou Huiai Hospital) — Guangzhou, Guangdong, China
Shanghai Mental Health Center — Shanghai, China
The Second Xiangya Hospital of Central South University — Hunan, China
Zhejiang University — Zhejiang, China

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Neurocognitive effects of six ketamine infusions and the association with antidepressant response in patients with unipolar and bipolar depression

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Rapid and longer-term antidepressant effects of repeated-dose intravenous ketamine for patients with unipolar and bipolar depression

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A comparison of the antianhedonic effects of repeated ketamine infusions in melancholic and non-melancholic depression

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