Estimate the Efficiency of the Association of an Injection of Ketamine and the Venlafaxine in the Severe Major Depressive Disorder for Six Weeks (KETADEP)

This study is currently recruiting participants. (see Contacts and Locations)

Verified March 2016 by University Hospital, Grenoble

Sponsor:

Information provided by (Responsible Party):

University Hospital, Grenoble

ClinicalTrials.gov Identifier:

NCT01557712

First received: March 15, 2012

Last updated: March 23, 2016

Last verified: March 2016

History of Changes

Purpose

The objective of this study is to evaluate the effectiveness of ketamine (infusion of 0.5mg/kg) and venlafaxine compared to the use of venlafaxine alone in the treatment of major depression (MADRS score ≥ 20 ) to six weeks of treatment.

Condition	Intervention	Phase
Major Depressive Disorder	Drug: ketamine venlafaxine Drug: Venlafaxine	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
Official Title:	Estimate the Efficiency of the Association of an Injection of Ketamine and the Venlafaxine in the Severe Major Depressive Disorder for Six Weeks.

Resource links provided by NLM:

Drug Information available for: Ketamine hydrochloride Ketamine Venlafaxine Venlafaxine hydrochloride

U.S. FDA Resources

Further study details as provided by University Hospital, Grenoble:

Primary Outcome Measures:

Depressive state [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
Assessment of depression by MADRS defining six weeks:
- the state of clinical response defined by a MADRS score less than 50% in MADRS score at baseline initial set.
- the state of clinical remission is defined by obtaining a MADRS score ≤ 7.


Estimated Enrollment:	40
Study Start Date:	March 2012
Estimated Study Completion Date:	February 2017
Estimated Primary Completion Date:	February 2017 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Ketamine+venlafaxine one injection of 0.5 mg/kg of kentamine the first day plus venlafaxine (150-225 mg day) during 6 weeks	Drug: ketamine venlafaxine After a washout period of 7 days of psychotropic medications with the exception of cyamemazine and hydroxyzine: Intravenous injection on day 0 to 0.5 mg / kg of ketamine D0 to D5: 75 mg of venlafaxine D5 to D28: 150 mg per day of venlafaxine D28 to D42: 150 mg daily of venlafaxine or 225 mg per day of venlafaxine if patient not responder to D28
Active Comparator: venlafaxine	Drug: Venlafaxine After a washout period of 7 days of psychotropic medications with the exception of cyamemazine and hydroxyzine: Intravenous injection on day 0 to 0.5 mg / kg of placebo (saline serum) D0 to D5: 75 mg of venlafaxine D5 to D28: 150 mg per day of venlafaxine D28 to D42: 150 mg daily of venlafaxine or 225 mg per day of venlafaxine if patient not responder to D28

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients aged 18 or over,
Introducing a single depressive episode or recurrent unipolar
Responding to the diagnosis of severe major depressive episode according to DSM IV (Diagnostic and Statistical Manual of Mental Disorders - Fourth Edition): MADRS score ≥ 20,
absence of treatment with ketamine for analgesia or anesthesia during the last 6 months
Affiliate (or beneficiary) to a social security system
Informed consent signed

Exclusion Criteria:

Contraindication to ketamine administration or treatment with venlafaxine;
Failure of treatment with venlafaxine in the current episode (as low as 150 mg for 15 days);
Axis I diagnosis according to DSM IV bipolar disorder (type I, II or III), schizoaffective disorder, schizophrenia, alcohol and other toxic or weaned for at least 6 months;
Major depressive episode with psychotic symptoms;
Current Episode resistant stage V according to the classification of Thase and Rush (failed a course of bilateral ECT);
Major depressive episode with severity criteria (significant risk of suicide is a MADRS score ≥ 5-SI; decubitus complications, intravenous hydration);
episode currently being treated with fluoxetine;
Patients hospitalized without their consent or measure of legal protection (guardianship, curatorship);
Affection Organic likely to affect cognitive abilities and brain structures (eg, HIV, MS, lupus, Parkinson's disease, epilepsy, dementia ...) or decompensation;
Pregnancy or breastfeeding underway.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01557712

Contacts


Contact: JEROME HOLTZMANN, MD		jholtzmann@chu-grenoble.fr
Contact: THIERRY BOUGEROL, MD, PhD		tbougerol@chu-grenoble.fr

Locations


France
Centre hospitalier universitaire	Recruiting
Grenoble, France, 38000
Contact: JEROME HOLTZMANN, MD jholtzmann@chu-grenoble.fr

Sponsors and Collaborators

University Hospital, Grenoble

More Information


Responsible Party:	University Hospital, Grenoble
ClinicalTrials.gov Identifier:	NCT01557712 History of Changes
Other Study ID Numbers:	1129
Study First Received:	March 15, 2012
Last Updated:	March 23, 2016
Health Authority:	France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:


Disease Depressive Disorder Depression Depressive Disorder, Major Pathologic Processes Mood Disorders Mental Disorders Behavioral Symptoms Ketamine Venlafaxine Hydrochloride 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 Serotonin and Noradrenaline Reuptake Inhibitors Neurotransmitter Uptake Inhibitors Membrane Transport Modulators Antidepressive Agents, Second-Generation Antidepressive Agents Psychotropic Drugs

Disease
Depressive Disorder
Depression
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms
Ketamine
Venlafaxine Hydrochloride
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
Serotonin and Noradrenaline Reuptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs

ClinicalTrials.gov processed this record on September 23, 2016

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