Clinical TrialTreatment-Resistant Depression (TRD)KetamineUnknown status

Clinical Trial of the Use of Ketamine in Treatment Resistant Depression

Single-group interventional study (n=20) testing intravenous low-dose ketamine (0.5 mg/kg) for treatment-resistant depression, with MRS and inflammatory serum markers as secondary measures.

Target Enrollment
20 participants
Study Type
Phase IV interventional
Design
Non-randomized

Detailed Description

Open single-group treatment study administering a single IV infusion of ketamine 0.5 mg/kg to participants with treatment-resistant depression (n=20).

Outcomes include clinical response in depression and mechanistic measures: glutamate neurotransmission by magnetic resonance spectroscopy and inflammatory serum markers (IL-6, TNF-alpha).

Study Arms & Interventions

Ketamine 0.5 mg/kg

experimental

IV ketamine 0.5 mg/kg for treatment-resistant depression patients (single-group).

Interventions

  • Ketamine0.5 mg/kg
    via IV• single dose• 1 doses total

    Single intravenous infusion 0.5 mg/kg.

Participants

Ages
18 – 65
Sexes
Male & Female

Inclusion Criteria

  • Treatment-Resistant Depression (Failure to respond to two or more trials of antidepressant monotherapy or failure to respond to four or more trials of different antidepressant therapies)
  • Acceptance of participation via the informed consent

Exclusion Criteria

  • Psychiatric comorbidity (except anxiety related disorders)
  • Substance abuse or dependence in the previous 3 months
  • Evidence of structural abnormalities in brain imaging
  • Pregnancy
  • Previous hypersensitivity to ketamine
  • Heart failure or insufficiency
  • Familial or personal history of psychosis
  • Glaucoma
  • Major neurological disease
  • Uncontrolled systemic arterial hypertension
  • MRI contraindications
  • Non-acceptance of participation via informed consent

Study Details

Locations

National Institute of Neurology and Neurosurgery — Mexico City, Mexico City, Mexico

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