Evaluation of the Initial Prescription of Ketamine and Milnacipran Forin Depression in Patients With a Progressive Disease
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 42
- Locations
- 9
- Primary Endpoint
- MADRS Score
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Milnacipran + Ketamine
Ketamine 0,5mg/kg single intravenous perfusion during 40 minutes. Milnacipran dosage depending of glomerular filtration rate of patient, during 16 days (doses of 25 or 50 mg or 100mg per day)
Intervention: Ketamine (Drug)
Milnacipran + Ketamine
Ketamine 0,5mg/kg single intravenous perfusion during 40 minutes. Milnacipran dosage depending of glomerular filtration rate of patient, during 16 days (doses of 25 or 50 mg or 100mg per day)
Intervention: Milnacipran (Drug)
Milnacipran + Placebo
Placebo single intravenous perfusion during 40 minutes. Milnacipran dosage depending of glomerular filtration rate of patient, during 16 days (doses of 25 or 50 mg or 100mg per day)
Intervention: Milnacipran (Drug)
Milnacipran + Placebo
Placebo single intravenous perfusion during 40 minutes. Milnacipran dosage depending of glomerular filtration rate of patient, during 16 days (doses of 25 or 50 mg or 100mg per day)
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
MADRS Score
Time Frame: At day 1, At day 2
Measure of the change of Depression Intensity
Secondary Outcomes
- Hospital Anxiety and Depression scale (HAD)(at day 0, at day 1, at day 2, at day 4, at day 8, at day 15)
- MADRS Score(at day 0, at day 4, at day 8, at day 15)
- Global Assessment Scale Operation (EGF)(at day 0, at day 15)
- Edmonton Symptom Assessment System ( ESAS )(at day 0, at day 1, at day 2, at day 4, at day 8, at day 15)
- Clinical Global Impression (CGI) Score(at day 0, at day 1, at day 2, at day 4, at day 8, at day 15)
- EUROHIS-QOL 8(at day 0, at day 15)
- 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)