Clinical trial · Interventional
Evaluation of the Initial Prescription of Ketamine and Milnacipran in Depression in Patients With a Progressive Disease
Evaluation of the Initial Prescription of Ketamine and Milnacipran Forin Depression in Patients With a Progressive Disease
NCT02783430CI-TRIAL-00099023KETAPALcompletedPhase 2 / Phase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Depression | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ketamine | Drug | — | UNRESOLVED |
| Milnacipran | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Milnacipran + Ketamine
- description
- 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)
- interventionNames
- Drug: Ketamine
- Drug: Milnacipran
- type
- ACTIVE_COMPARATOR
- label
- Milnacipran + Placebo
- description
- 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)
- interventionNames
- Drug: Milnacipran
- Drug: Placebo
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (52)
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- BACKGROUNDLepine JP, Gasquet I, Kovess V, Arbabzadeh-Bouchez S, Negre-Pages L, Nachbaur G, Gaudin AF. [Prevalence and comorbidity of psychiatric disorders in the French general population]. Encephale. 2005 Mar-Apr;31(2):182-94. doi: 10.1016/s0013-7006(05)82385-1. French. PMID 15959445
- BACKGROUNDMitchell AJ, Chan M, Bhatti H, Halton M, Grassi L, Johansen C, Meader N. Prevalence of depression, anxiety, and adjustment disorder in oncological, haematological, and palliative-care settings: a meta-analysis of 94 interview-based studies. Lancet Oncol. 2011 Feb;12(2):160-74. doi: 10.1016/S1470-2045(11)70002-X. Epub 2011 Jan 19. PMID 21251875
- BACKGROUNDAtassi N, Cook A, Pineda CM, Yerramilli-Rao P, Pulley D, Cudkowicz M. Depression in amyotrophic lateral sclerosis. Amyotroph Lateral Scler. 2011 Mar;12(2):109-12. doi: 10.3109/17482968.2010.536839. Epub 2010 Nov 24. PMID 21091399
- BACKGROUNDRutledge T, Reis VA, Linke SE, Greenberg BH, Mills PJ. Depression in heart failure a meta-analytic review of prevalence, intervention effects, and associations with clinical outcomes. J Am Coll Cardiol. 2006 Oct 17;48(8):1527-37. doi: 10.1016/j.jacc.2006.06.055. Epub 2006 Sep 26. PMID 17045884
- BACKGROUNDAraujo SM, de Bruin VM, Daher Ede F, Almeida GH, Medeiros CA, de Bruin PF. Risk factors for depressive symptoms in a large population on chronic hemodialysis. Int Urol Nephrol. 2012 Aug;44(4):1229-35. doi: 10.1007/s11255-011-0032-9. Epub 2011 Jul 22. PMID 21779919