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Trial record 40 of 40 for:    Recruiting, Not yet recruiting, Available Studies | "Hospice Care"

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 : May 18, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Lille

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.

Condition or disease Intervention/treatment Phase
Depression Drug: Ketamine Drug: Milnacipran Drug: Placebo Phase 2 Phase 3

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  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of the Initial Prescription of Ketamine and Milnacipran for Depression in Palliative Care
Actual Study Start Date : September 8, 2016
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : November 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Palliative Care

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




Primary Outcome Measures :
  1. MADRS Score [ Time Frame: At day 1, At day 2 ]
    Measure of the change of Depression Intensity


Secondary Outcome Measures :
  1. 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).

  2. 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.

  3. 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.

  4. 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).

  5. 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

  6. 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 .

  7. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02783430


Contacts
Contact: Antoine LEMAIRE, MD lemaire-a@ch-valenciennes.fr

Locations
France
University Hospital, Not yet recruiting
Lille, France
Contact: Magali Pierrat, MD         
Principal Investigator: Magali Pierrat, MD         
Centre Hospitalier de Valenciennes Recruiting
Valenciennes, France
Principal Investigator: Antoine Lemaire, MD         
Sponsors and Collaborators
University Hospital, Lille
Investigators
Study Chair: Antoine LEMAIRE, MD Hospital of Valenciennes

Additional Information:
Publications:

Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT02783430     History of Changes
Other Study ID Numbers: 2014_22
2014-004361-24 ( EudraCT Number )
PHRCI_2013 ( Other Identifier: PHRC Number, DGOS )
First Posted: May 26, 2016    Key Record Dates
Last Update Posted: May 18, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Undecided yet

Keywords provided by University Hospital, Lille:
Ketamine
Palliative care
Supportive care
Early palliative care
Fast acting antidepressant
End of life care
Cancer
psychological distress
antidepressant
serotonin norepinephrine reuptake inhibitors

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Ketamine
Milnacipran
Antidepressive Agents
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Serotonin Agents
Adrenergic Uptake Inhibitors
Adrenergic Agents