Try our beta test site

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 has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Grenoble
ClinicalTrials.gov Identifier:
NCT01557712
First received: March 15, 2012
Last updated: February 23, 2017
Last verified: January 2017
  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
Intervention Model: Single Group Assignment
Masking: Participant, Care Provider, 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:


Further study details as provided by University Hospital, Grenoble:

Primary Outcome Measures:
  • Depressive state [ Time Frame: 6 weeks ]

    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 ≤ 8.


Enrollment: 25
Actual Study Start Date: March 2012
Study Completion Date: January 2017
Primary Completion Date: January 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 (150-375 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 D4: 75 mg of venlafaxine
  • D4 to D14: 150 mg per day of venlafaxine
  • D14 to D42: 150 mg daily of venlafaxine to 375 mg per day of venlafaxine if patient not responder
Active Comparator: venlafaxine
venlafaxine (150-375 mg day) during 6 weeks
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 D4: 75 mg of venlafaxine
  • D4 to D14: 150 mg per day of venlafaxine
  • D14 to D42: 150 mg daily of venlafaxine to 375 mg per day of venlafaxine if patient not responder

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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;
  • 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

Locations
France
Centre hospitalier universitaire
Grenoble, France, 38000
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: February 23, 2017

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

ClinicalTrials.gov processed this record on February 24, 2017