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CompletedPhase 2 / Phase 3

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

NCT02783430 · KETAPAL · University Hospital, Lille

Closed to entry
Status
Not accepting participants
Phase 2 / Phase 3
Phase
42
Target enrolment
9
Study sites
Outside the US

What it is testing

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.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • MADRS Score

    Measured over At day 1, At day 2

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years
Ages
All
Sex
Not accepted
Healthy volunteers
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

Where

9 study sites

FacilityCityRegionCountry
Chu Amiens PicardieAmiensFrance
Ch CalaisCalaisFrance
Maison Medicale Jean Xxiii - LilleLilleFrance
University Hospital,LilleFrance
Groupt Hopitaux Instit Catho de Lille - LommeLommeFrance
C.H de RoubaixRoubaixFrance
Ch Ghpso SenlisSenlisFrance
Ch TourcoingTourcoingFrance
Centre Hospitalier de ValenciennesValenciennesFrance

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT02783430 on ClinicalTrials.gov →

Last updated in the registry 2025-12-16. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits

Substance

Indication