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

Depression Clinical Trial

— KETAPAL  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02783430
• Other study ID #: 2014_22
• Secondary ID: 2014-004361-24PH
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: September 8, 2016
• Est. completion date: September 2024

Study information

• Verified date: August 2022
• Source: University Hospital, Lille
• Contact: Antoine LEMAIRE, MD
• Email: lemaire-a[@]ch-valenciennes.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Disease Progression

Intervention

Drug:
• Ketamine
One single perfusion of 0.5 mg/kg during 40 minutes at the beginning of the inclusion
• 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)
• Placebo
One single perfusion during 40 minutes at the beginning of the inclusion

Locations

Country	Name	City	State
France	Chu Amiens Picardie	Amiens
France	Ch Calais	Calais
France	Maison Medicale Jean Xxiii - Lille	Lille
France	University Hospital,	Lille
France	Groupt Hopitaux Instit Catho de Lille - Lomme	Lomme
France	C.H de Roubaix	Roubaix
France	Ch Ghpso Senlis	Senlis
France	Ch Tourcoing	Tourcoing
France	Centre Hospitalier de Valenciennes	Valenciennes

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

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* Note: There are 52 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MADRS Score	Measure of the change of Depression Intensity	At day 1, At day 2
Secondary	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).	at day 0, at day 15
Secondary	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.	at day 0, at day 1, at day 2, at day 4, at day 8, at day 15
Secondary	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.	at day 0, at day 1, at day 2, at day 4, at day 8, at day 15
Secondary	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).	at day 0, at day 4, at day 8, at day 15
Secondary	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	at day 0, at day 1, at day 2, at day 4, at day 8, at day 15
Secondary	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 .	at day 0, at day 15
Secondary	Edmonton Symptom Assessment System ( ESAS )	Symptom Assessment Scale	at day 0, at day 1, at day 2, at day 4, at day 8, at day 15

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