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

Primary Purpose

Depression

Status
Recruiting
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Ketamine
Milnacipran
Placebo
Sponsored by
University Hospital, Lille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring Ketamine, Palliative care, Supportive care, Early palliative care, Fast acting antidepressant, End of life care, Cancer, psychological distress, antidepressant, serotonin norepinephrine reuptake inhibitors

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Chu Amiens PicardieRecruiting
  • Ch CalaisRecruiting
  • Maison Medicale Jean Xxiii - LilleRecruiting
  • University Hospital,Recruiting
  • Groupt Hopitaux Instit Catho de Lille - LommeRecruiting
  • C.H de RoubaixRecruiting
  • Ch Ghpso SenlisRecruiting
  • Ch TourcoingRecruiting
  • Centre Hospitalier de ValenciennesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Milnacipran + Ketamine

Milnacipran + Placebo

Arm 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)

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)

Outcomes

Primary Outcome Measures

MADRS Score
Measure of the change of Depression Intensity

Secondary Outcome Measures

EUROHIS-QOL 8
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).
Number of request of early death (suicidal intentions or euthanasia or physician-assisted suicide)
measure request of suicidal intentions made by the patient on explicit request of the clinician.
Hospital Anxiety and Depression scale (HAD)
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
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).
Clinical Global Impression (CGI) Score
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
Global Assessment Scale Operation (EGF)
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 )
Symptom Assessment Scale

Full Information

First Posted
May 12, 2016
Last Updated
November 3, 2022
Sponsor
University Hospital, Lille
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1. Study Identification

Unique Protocol Identification Number
NCT02783430
Brief Title
Evaluation of the Initial Prescription of Ketamine and Milnacipran in Depression in Patients With a Progressive Disease
Acronym
KETAPAL
Official Title
Evaluation of the Initial Prescription of Ketamine and Milnacipran Forin Depression in Patients With a Progressive Disease
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 8, 2016 (Actual)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Lille

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Milnacipran + Ketamine
Arm Type
Experimental
Arm 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)
Arm Title
Milnacipran + Placebo
Arm Type
Active Comparator
Arm 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)
Intervention Type
Drug
Intervention Name(s)
Ketamine
Intervention Description
One single perfusion of 0.5 mg/kg during 40 minutes at the beginning of the inclusion
Intervention Type
Drug
Intervention Name(s)
Milnacipran
Intervention Description
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)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
One single perfusion during 40 minutes at the beginning of the inclusion
Primary Outcome Measure Information:
Title
MADRS Score
Description
Measure of the change of Depression Intensity
Time Frame
At day 1, At day 2
Secondary Outcome Measure Information:
Title
EUROHIS-QOL 8
Description
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).
Time Frame
at day 0, at day 15
Title
Number of request of early death (suicidal intentions or euthanasia or physician-assisted suicide)
Description
measure request of suicidal intentions made by the patient on explicit request of the clinician.
Time Frame
at day 0, at day 1, at day 2, at day 4, at day 8, at day 15
Title
Hospital Anxiety and Depression scale (HAD)
Description
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.
Time Frame
at day 0, at day 1, at day 2, at day 4, at day 8, at day 15
Title
MADRS Score
Description
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).
Time Frame
at day 0, at day 4, at day 8, at day 15
Title
Clinical Global Impression (CGI) Score
Description
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
Time Frame
at day 0, at day 1, at day 2, at day 4, at day 8, at day 15
Title
Global Assessment Scale Operation (EGF)
Description
Global Assessment of Functioning is a numerical scale ( from 0 to 100) used to evaluate the psychological, social and work of an individual .
Time Frame
at day 0, at day 15
Title
Edmonton Symptom Assessment System ( ESAS )
Description
Symptom Assessment Scale
Time Frame
at day 0, at day 1, at day 2, at day 4, at day 8, at day 15

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Antoine LEMAIRE, MD
Email
lemaire-a@ch-valenciennes.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antoine LEMAIRE, MD
Organizational Affiliation
Hospital of Valenciennes
Official's Role
Study Chair
Facility Information:
Facility Name
Chu Amiens Picardie
City
Amiens
Country
France
Individual Site Status
Recruiting
Facility Name
Ch Calais
City
Calais
Country
France
Individual Site Status
Recruiting
Facility Name
Maison Medicale Jean Xxiii - Lille
City
Lille
ZIP/Postal Code
59037
Country
France
Individual Site Status
Recruiting
Facility Contact:
Phone
0320445962
Facility Name
University Hospital,
City
Lille
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Magali Pierrat, MD
First Name & Middle Initial & Last Name & Degree
Magali Pierrat, MD
Facility Name
Groupt Hopitaux Instit Catho de Lille - Lomme
City
Lomme
Country
France
Individual Site Status
Recruiting
Facility Name
C.H de Roubaix
City
Roubaix
Country
France
Individual Site Status
Recruiting
Facility Name
Ch Ghpso Senlis
City
Senlis
Country
France
Individual Site Status
Recruiting
Facility Name
Ch Tourcoing
City
Tourcoing
Country
France
Individual Site Status
Recruiting
Facility Name
Centre Hospitalier de Valenciennes
City
Valenciennes
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antoine Lemaire, MD

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Undecided yet
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Evaluation of the Initial Prescription of Ketamine and Milnacipran in Depression in Patients With a Progressive Disease

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