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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
42
One single perfusion of 0.5 mg/kg during 40 minutes at the beginning of the inclusion
One or two caps per day from the beginning of the inclusion. Milnacipran dosage depending of glomerular filtration rate of patient, during 16 days (doses of 25 or 50 mg or 100mg per day)
One single perfusion during 40 minutes at the beginning of the inclusion
Chu Amiens Picardie
Amiens, France
Ch Calais
Calais, France
Maison Medicale Jean Xxiii - Lille
Lille, France
University Hospital,
Lille, France
MADRS Score
Measure of the change of Depression Intensity
Time frame: At day 1, At day 2
EUROHIS-QOL 8
Measure of the improvement of quality of life after 15 days of treatment. EUROHIS-QOL 8-item index, a shortened version of the World Health Organization Quality of Life Instrument-Abbreviated Version (WHOQOL-BREF).
Time frame: at day 0, at day 15
Number of request of early death (suicidal intentions or euthanasia or physician-assisted suicide)
measure request of suicidal intentions made by the patient on explicit request of the clinician.
Time frame: at day 0, at day 1, at day 2, at day 4, at day 8, at day 15
Hospital Anxiety and Depression scale (HAD)
The items of the scale limit confounding factors related to physical comorbidity . The answers are simple and quick . It is a wide choice and recommended for depression studies in palliative care.
Time frame: at day 0, at day 1, at day 2, at day 4, at day 8, at day 15
MADRS Score
The MADRS scale quantifies the intensity of depressive symptoms, determine the number of responders (reduction in the initial score greater than or equal to 50%) and the number of patients in remission (score less than 7).
Time frame: at day 0, at day 4, at day 8, at day 15
Clinical Global Impression (CGI) Score
These hetero fast and well validated assessments help to complete the assessment by the clinician on the severity of the patient's situation and overall improvement
Time frame: at day 0, at day 1, at day 2, at day 4, at day 8, at day 15
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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
Global Assessment Scale Operation (EGF)
Global Assessment of Functioning is a numerical scale ( from 0 to 100) used to evaluate the psychological, social and work of an individual .
Time frame: at day 0, at day 15
Edmonton Symptom Assessment System ( ESAS )
Symptom Assessment Scale
Time frame: at day 0, at day 1, at day 2, at day 4, at day 8, at day 15