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Evaluation of the Initial Prescription of Ketamine and Milnacipran for Depression in Palliative Care (KETAPAL)

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ClinicalTrials.gov Identifier: NCT02783430
Recruitment Status : Recruiting
First Posted : May 26, 2016
Last Update Posted : December 11, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Lille

Tracking Information
First Submitted Date  ICMJE May 12, 2016
First Posted Date  ICMJE May 26, 2016
Last Update Posted Date December 11, 2018
Actual Study Start Date  ICMJE September 8, 2016
Estimated Primary Completion Date September 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 26, 2016)
MADRS Score [ Time Frame: At day 1, At day 2 ]
Measure of the change of Depression Intensity
Original Primary Outcome Measures  ICMJE
 (submitted: May 23, 2016)
MADRS Score [ Time Frame: At day 1, At day 2 ]
Measure of the Reduction of Depression Intensity
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 23, 2016)
  • 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).
  • 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.
  • 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.
  • 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).
  • 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
  • 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 .
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of the Initial Prescription of Ketamine and Milnacipran for Depression in Palliative Care
Official Title  ICMJE Evaluation of the Initial Prescription of Ketamine and Milnacipran for Depression in Palliative Care
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Depression
Intervention  ICMJE
  • 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)
  • Drug: Placebo
    One single perfusion during 40 minutes at the beginning of the inclusion
Study Arms  ICMJE
  • 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)
    Interventions:
    • Drug: Ketamine
    • Drug: Milnacipran
  • 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)
    Interventions:
    • Drug: Milnacipran
    • Drug: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 23, 2016)
80
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2019
Estimated Primary Completion Date September 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Antoine LEMAIRE, MD lemaire-a@ch-valenciennes.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02783430
Other Study ID Numbers  ICMJE 2014_22
2014-004361-24 ( EudraCT Number )
PHRCI_2013 ( Other Identifier: PHRC Number, DGOS )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Plan Description: Undecided yet
Responsible Party University Hospital, Lille
Study Sponsor  ICMJE University Hospital, Lille
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Antoine LEMAIRE, MD Hospital of Valenciennes
PRS Account University Hospital, Lille
Verification Date December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP