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

• Status: Recruiting
• Trial end date: 2021-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Lille
• Treatments: Antidepressive Agents; Ketamine; Levomilnacipran; Milnacipran

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 in its version 5

• MADRS > 19 ( moderate to severe)

• No antidepressant treatment or treatment introduced for more than four weeks

• In ability 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 upper than 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