Clinical trial NCT02783430: Evaluation of the Initial Prescription of Ketamine and Milnacipran in Depression in Patients With a Progressive Disease
Official title: Evaluation of the Initial Prescription of Ketamine and Milnacipran Forin Depression in Patients With a Progressive Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Depression
Keywords: Ketamine
Palliative care
Supportive care
Early palliative care
Fast acting antidepressant
End of life care
Cancer
psychological distress
antidepressant
serotonin norepinephrine reuptake inhibitors
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2016-05-26
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: Ketamine, a molecule mainly used as an analgesic in palliative care, turns out to be an excellent fast acting antidepressant. By acting as an NMDA receptor antagonist, its mechanism of action is complementary to classical and long acting antidepressants like Selective Serotonin Reuptake Inhibitors (SSRI). In particular, ketamine is able to boost synaptogenesis in only a few hours whereas long-term prescription of SSRI can stimulate neurogenesis.

The purpose of this study is to evaluate a new therapeutic strategy that could integrate ketamine in the same time than SSRI, to control depression symptoms faster and optimize patient's quality of life complementary to treatments of cancer.

Eligibility 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

Primary outcomes:
measure: MADRS Score
timeFrame: At day 1, At day 2
Secondary outcomes:
measure: EUROHIS-QOL 8
timeFrame: at day 0, at day 15
measure: Number of request of early death (suicidal intentions or euthanasia or physician-assisted suicide)
timeFrame: at day 0, at day 1, at day 2, at day 4, at day 8, at day 15
measure: Hospital Anxiety and Depression scale (HAD)
timeFrame: at day 0, at day 1, at day 2, at day 4, at day 8, at day 15
measure: MADRS Score
timeFrame: at day 0, at day 4, at day 8, at day 15
measure: Clinical Global Impression (CGI) Score
timeFrame: at day 0, at day 1, at day 2, at day 4, at day 8, at day 15
measure: Global Assessment Scale Operation (EGF)
timeFrame: at day 0, at day 15
measure: Edmonton Symptom Assessment System ( ESAS )
timeFrame: at day 0, at day 1, at day 2, at day 4, at day 8, at day 15
Other outcomes:
Locations:
city: Amiens
country: France
facility: Chu Amiens Picardie
city: Calais
country: France
facility: Ch Calais
city: Lille
country: France
facility: Maison Medicale Jean Xxiii - Lille
city: Lille
country: France
facility: University Hospital,
city: Lomme
country: France
facility: Groupt Hopitaux Instit Catho de Lille - Lomme
city: Roubaix
country: France
facility: C.H de Roubaix
city: Senlis
country: France
facility: Ch Ghpso Senlis
city: Tourcoing
country: France
facility: Ch Tourcoing
city: Valenciennes
country: France
facility: Centre Hospitalier de Valenciennes
Study officials:
affiliation: Hospital of Valenciennes
name: Antoine LEMAIRE, MD
role: STUDY_CHAIR
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