Evaluation of the Initial Prescription of... — Clinical Trial Details

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.

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:
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

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

Detailed Description

Study Protocol

Preparation

Dosing

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Integration

Study Arms & Interventions

Milnacipran + Ketamine

Interventions

Milnacipran + Placebo

Interventions

Participants

Inclusion Criteria

Exclusion Criteria

Study Details

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