Evaluation of the Initial Prescription of Ketamine and Milnacipran in Depression in Patients With a Progressive Disease

NCT02783430 | Completed Phase 2 DMC

• 3 other identifiers: 2014_222014-004361-24PHRCI_2013
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 9

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.

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

Outcome Measures

Primary Outcomes (1)

• MADRS Score

  Measure of the change of Depression Intensity

  At day 1, At day 2

Secondary Outcomes (7)

• 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

• 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

• Clinical Global Impression (CGI) Score

  at day 0, at day 1, at day 2, at day 4, at day 8, at day 15

Study Arms (2)

Milnacipran + Ketamine

EXPERIMENTAL

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)

Drug: Ketamine; Drug: Milnacipran

Milnacipran + Placebo

ACTIVE COMPARATOR

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)

Drug: Milnacipran; Drug: Placebo

Interventions

Ketamine DRUG

One single perfusion of 0.5 mg/kg during 40 minutes at the beginning of the inclusion

Milnacipran + Ketamine

Placebo DRUG

One single perfusion during 40 minutes at the beginning of the inclusion

Milnacipran + Placebo

Milnacipran DRUG

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)

Milnacipran + Ketamine; Milnacipran + Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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
• lactating women
• intolerance or allergic reaction to ketamine or milnacipran.
• contraindications to the association of ketamine or milnacipran with the patient's usual treatment

Sponsors & Collaborators

• University Hospital, Lille: lead

Study Sites (9)

Chu Amiens Picardie

Amiens, France

Location

Ch Calais

Calais, France

Location

Maison Medicale Jean Xxiii - Lille

Lille, 59037, France

Location

University Hospital,

Lille, France

Location

Groupt Hopitaux Instit Catho de Lille - Lomme

Lomme, France

Location

C.H de Roubaix

Roubaix, France

Location

Ch Ghpso Senlis

Senlis, France

Location

Ch Tourcoing

Tourcoing, France

Location

Centre Hospitalier de Valenciennes

Valenciennes, France

Location

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MeSH Terms

Conditions

Depression; Neoplasms

Interventions

Ketamine; Milnacipran

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Cyclopropanes

Study Officials

• Antoine LEMAIRE, MD

  Hospital of Valenciennes

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2016
• First Posted: May 26, 2016
• Study Start: September 8, 2016
• Primary Completion: March 8, 2024
• Study Completion: March 8, 2024
• Last Updated: December 16, 2025

Record last verified: 2025-12

Locations

FR (9)