Clinical TrialMajor Depressive Disorder (MDD)KetaminePlaceboCompleted

Evaluation of the Initial Prescription of Ketamine and Milnacipran in Depression in Patients With a Progressive Disease

KetaPal is a placebo-controlled randomized trial designed to demonstrate the antidepressant action of ketamine in palliative care situations. Half of participants will receive Ketamine and Milnacipran in combination, while the other half will receive a Placebo and Milnacipran in combination.

Target Enrollment
80 participants
Study Type
Phase II/III interventional
Design
Randomized, quadruple Blind

Detailed Description

Randomized, quadruple-blind, parallel-group Phase II/III trial (n=80) testing a single IV ketamine infusion (0.5 mg/kg over 40 minutes) plus milnacipran versus placebo infusion plus milnacipran in inpatients receiving palliative care with major depressive disorder (MADRS > 19).

Milnacipran is initiated at inclusion and continued for 16 days with doses adjusted by renal function (25–100 mg/day). The primary aim is to assess antidepressant efficacy and improve quality of life in progressive disease.

Study Protocol

Preparation

sessions

Dosing

1 sessions
40 min each

Integration

sessions

Study Arms & Interventions

Milnacipran + Ketamine

experimental

Ketamine 0.5 mg/kg IV infusion over 40 minutes plus milnacipran for 16 days (dose per GFR).

Interventions

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

    40-minute IV infusion

  • Compound
    via Oral• daily for 16 days

    Milnacipran 25–100 mg/day (dose adjusted by renal function)

Milnacipran + Placebo

active comparator

Placebo IV infusion over 40 minutes plus milnacipran for 16 days (dose per GFR).

Interventions

  • Placebo
    via IV• single dose• 1 doses total

    40-minute IV infusion (placebo)

  • Compound
    via Oral• daily for 16 days

    Milnacipran 25–100 mg/day (dose adjusted by renal function)

Participants

Ages
18 – 99
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • Inpatient
  • Supported by a functional palliative care unit
  • Having a severe and progressive disease diagnosed
  • Meet the criteria for major depressive disorder as defined by DSM-5
  • MADRS > 19 (moderate to severe)
  • No antidepressant treatment or treatment introduced for more than four weeks
  • Inability to receive clear information and give consent
  • Beneficiary of a social security scheme

Exclusion Criteria

  • Exclusion Criteria:
  • upper weight or equal to 100 kg
  • ultimate phase (about 24 to 72 hours prior to death)
  • unstable patient on cardiovascular diseases, including uncontrolled hypertension
  • severe renal impairment (renal clearance less than 15 ml/min)
  • psychiatric comorbidity: schizophrenia and schizoaffective disorder
  • neurological comorbidity: recent cerebrovascular accident (less than one month), Parkinson's disease, dementia
  • treatment with ketamine received in the four weeks preceding the inclusion
  • impaired judgment, cognitive or massive sensory impairment not allowing to receive clear information
  • oral antidepressant treatment introduced less than four weeks ago
  • dosage of oral antidepressant treatment above the marketing authorization for more than four weeks
  • patient not covered by the social security system
  • refusal to sign the consent
  • minor patient or guardianship
  • pregnant women (implementation of a urine pregnancy test before inclusion for women of childbearing age)
  • lactating women
  • intolerance or allergic reaction to ketamine or milnacipran
  • contraindications to the association of ketamine or milnacipran with the patient's usual treatment

Study Details

Locations

Chu Amiens Picardie — Amiens, France
Ch Calais — Calais, France
Maison Medicale Jean Xxiii - Lille — Lille, France
University Hospital, — Lille, France
Groupt Hopitaux Instit Catho de Lille - Lomme — Lomme, France
C.H de Roubaix — Roubaix, France
Ch Ghpso Senlis — Senlis, France
Ch Tourcoing — Tourcoing, France
Centre Hospitalier de Valenciennes — Valenciennes, France

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