Clinical TrialMajor Depressive Disorder (MDD)KetaminePlaceboCompleted

Estimate the Efficiency of the Association of an Injection of Ketamine and the Venlafaxine in the Severe Major Depressive Disorder for Six Weeks

Randomised Phase III trial (n=25) comparing a single IV ketamine infusion (0.5 mg/kg) plus a 6-week venlafaxine regimen versus venlafaxine alone in severe major depressive disorder (MADRS ≥20).

Target Enrollment
25 participants
Study Type
Phase III interventional
Design
Randomized, triple Blind

Detailed Description

Randomised, triple-masked phase III study enrolling 25 adults with severe major depressive disorder to evaluate whether a single ketamine infusion (0.5 mg/kg) added to a 6-week venlafaxine regimen improves depressive symptoms versus venlafaxine with IV saline placebo.

Venlafaxine dosing: D0–D4 75 mg; D4–D14 150 mg/day; D14–D42 150 mg/day up to 375 mg/day if not responder. Primary outcomes assessed over six weeks; safety monitored throughout.

Study Protocol

Preparation

sessions

Dosing

1 sessions

Integration

sessions

Study Arms & Interventions

Ketamine + venlafaxine

experimental

Single IV ketamine 0.5 mg/kg on day 0 plus venlafaxine oral regimen for 6 weeks.

Interventions

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

    IV infusion on day 0 (0.5 mg/kg).

  • Compound75 - 375 mg
    via Oral• daily

    Venlafaxine schedule: D0–D4 75 mg; D4–D14 150 mg/day; D14–D42 150→375 mg/day if non-responder.

Venlafaxine

active comparator

Venlafaxine oral regimen with saline IV placebo on day 0.

Interventions

  • Placebo
    via IV• single dose

    Saline placebo infusion on day 0.

  • Compound75 - 375 mg
    via Oral• daily

    Venlafaxine schedule: D0–D4 75 mg; D4–D14 150 mg/day; D14–D42 150→375 mg/day if non-responder.

Participants

Ages
18 – 99
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • Patients aged 18 or over
  • Single depressive episode or recurrent unipolar
  • Diagnosis of severe major depressive episode according to DSM IV: MADRS score ≥ 20
  • No ketamine for analgesia/anesthesia in last 6 months
  • Affiliated to a social security system
  • Signed informed consent

Exclusion Criteria

  • Exclusion Criteria:
  • Contraindication to ketamine or venlafaxine
  • Failure of treatment with venlafaxine in the current episode (≥150 mg for 15 days)
  • Axis I bipolar disorder (I, II or III), schizoaffective disorder, schizophrenia; alcohol or other substance dependence or abstinent <6 months
  • Current episode resistant stage V (Thase and Rush) or failed bilateral ECT
  • Major depressive episode with severity criteria (significant suicide risk as MADRS item 5 - SI; decubitus complications, need for IV hydration)
  • Episode currently treated with fluoxetine
  • Patients under legal protection (guardianship, curatorship)
  • Organic conditions likely to affect cognition/brain (e.g., HIV, MS, lupus, Parkinson's, epilepsy, dementia) or decompensation
  • Pregnancy or breastfeeding

Study Details

Locations

Centre hospitalier universitaire — Grenoble, France

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