Clinical TrialTreatment-Resistant Depression (TRD)KetaminePlaceboUnknown status

Ketamine for Treatment-resistant Depression: A Multicentric Clinical Trial in Mexican Population

Randomised multicentric parallel-arm Phase II study (n=60) testing single 0.5 mg/kg IV ketamine infusion versus saline placebo for treatment-resistant depression in Mexican clinical sites.

Target Enrollment
60 participants
Study Type
Phase II interventional
Design
Randomized, triple Blind

Detailed Description

Multicentre, randomised, triple-blind, parallel-group trial assessing efficacy of a single 0.5 mg/kg IV ketamine infusion compared with saline placebo in adults with treatment-resistant major depressive disorder.

Primary purpose is treatment; dosing is a single 40-minute IV infusion with standard safety monitoring at three national health provider clinics in Mexico.

Study Protocol

Preparation

sessions

Dosing

1 sessions
40 min each

Integration

sessions

Study Arms & Interventions

Ketamine

experimental

Single 0.5 mg/kg IV ketamine infusion (active treatment)

Interventions

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

    IV infusion over 40 minutes

Placebo

inactive

Saline 0.9% IV infusion (placebo comparator)

Interventions

  • Placebo
    via IV• single dose• 1 doses total

    Saline 0.9% IV infusion over 40 minutes

Participants

Ages
18 – 65
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • Age: 18-65 years old
  • Major Depressive Disorder diagnosis based on DSM-IV TR
  • Classification of MDD as treatment-resistant
  • No brain structural abnormalities as evidenced by an MRI scan
  • Signed acceptance of Informed Consent

Exclusion Criteria

  • Exclusion Criteria:
  • Other psychiatric diagnosis apart from MDD
  • Substance abuse or dependence (prior or during study)
  • Pregnancy
  • Congestive heart disease
  • Personal history of psychosis
  • First-degree relative with history of psychosis
  • Glaucoma
  • Present neurological disease
  • High blood or pulmonary artery pressure
  • Declining the signing of the informed consent

Study Details

Locations

ABC Neurological Center — Mexico City, Mexico City, Mexico

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