Depression
Conditions
Keywords
Ketamine, Palliative care, Supportive care, Early palliative care, Fast acting antidepressant, End of life care, Cancer, psychological distress, antidepressant, serotonin norepinephrine reuptake inhibitors
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.
Interventions
DRUGKetamine
One single perfusion of 0.5 mg/kg during 40 minutes at the beginning of the inclusion
DRUGMilnacipran
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)
DRUGPlacebo
One single perfusion during 40 minutes at the beginning of the inclusion
Sponsors
University Hospital, Lille
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| MADRS Score | At day 1, At day 2 | Measure of the change of Depression Intensity |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of request of early death (suicidal intentions or euthanasia or physician-assisted suicide) | at day 0, at day 1, at day 2, at day 4, at day 8, at day 15 | measure request of suicidal intentions made by the patient on explicit request of the clinician. |
| Hospital Anxiety and Depression scale (HAD) | at day 0, at day 1, at day 2, at day 4, at day 8, at day 15 | 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. |
| MADRS Score | at day 0, at day 4, at day 8, at day 15 | 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). |
| EUROHIS-QOL 8 | at day 0, at day 15 | 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). |
| Global Assessment Scale Operation (EGF) | at day 0, at day 15 | Global Assessment of Functioning is a numerical scale ( from 0 to 100) used to evaluate the psychological, social and work of an individual . |
| Edmonton Symptom Assessment System ( ESAS ) | at day 0, at day 1, at day 2, at day 4, at day 8, at day 15 | Symptom Assessment Scale |
| Clinical Global Impression (CGI) Score | at day 0, at day 1, at day 2, at day 4, at day 8, at day 15 | 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 |
Countries
France
Outcome results
None listed