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

November 3, 2022 updated by: University Hospital, Lille

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Amiens, France
        • Recruiting
        • CHU Amiens Picardie
      • Calais, France
        • Recruiting
        • Ch Calais
      • Lille, France, 59037
        • Recruiting
        • Maison Medicale Jean Xxiii - Lille
      • Lille, France
        • Recruiting
        • University Hospital,
        • Contact:
          • Magali Pierrat, MD
        • Principal Investigator:
          • Magali Pierrat, MD
      • Lomme, France
        • Recruiting
        • Groupt Hopitaux Instit Catho de Lille - Lomme
      • Roubaix, France
        • Recruiting
        • C.H de Roubaix
      • Senlis, France
        • Recruiting
        • Ch Ghpso Senlis
      • Tourcoing, France
        • Recruiting
        • Ch Tourcoing
      • Valenciennes, France
        • Recruiting
        • Centre Hospitalier de Valenciennes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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)
Drug: Ketamine
One single perfusion of 0.5 mg/kg during 40 minutes at the beginning of the inclusion
Drug: Milnacipran
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)
Active Comparator: 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)
Drug: Milnacipran
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)
Drug: Placebo
One single perfusion during 40 minutes at the beginning of the inclusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MADRS Score
Time Frame: At day 1, At day 2
Measure of the change of Depression Intensity
At day 1, At day 2

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
EUROHIS-QOL 8
Time Frame: 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).
at day 0, at day 15
Number of request of early death (suicidal intentions or euthanasia or physician-assisted suicide)
Time Frame: 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.
at day 0, at day 1, at day 2, at day 4, at day 8, at day 15
Hospital Anxiety and Depression scale (HAD)
Time Frame: 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.
at day 0, at day 1, at day 2, at day 4, at day 8, at day 15
MADRS Score
Time Frame: 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).
at day 0, at day 4, at day 8, at day 15
Clinical Global Impression (CGI) Score
Time Frame: 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
at day 0, at day 1, at day 2, at day 4, at day 8, at day 15
Global Assessment Scale Operation (EGF)
Time Frame: 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 .
at day 0, at day 15
Edmonton Symptom Assessment System ( ESAS )
Time Frame: at day 0, at day 1, at day 2, at day 4, at day 8, at day 15
Symptom Assessment Scale
at day 0, at day 1, at day 2, at day 4, at day 8, at day 15

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Lille

Investigators

  • Study Chair: Antoine LEMAIRE, MD, Hospital of Valenciennes

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 8, 2016

Primary Completion (Anticipated)

September 1, 2024

Study Completion (Anticipated)

September 1, 2024

Study Registration Dates

First Submitted

May 12, 2016

First Submitted That Met QC Criteria

May 23, 2016

First Posted (Estimate)

May 26, 2016

Study Record Updates

Last Update Posted (Actual)

November 4, 2022

Last Update Submitted That Met QC Criteria

November 3, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014_22
  • 2014-004361-24 (EudraCT Number)
  • PHRCI_2013 (Other Identifier: PHRC Number, DGOS)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

Undecided yet

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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