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

Primary Purpose

Major Depressive Disorder

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
ketamine venlafaxine
Venlafaxine
Sponsored by
University Hospital, Grenoble
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Centre hospitalier universitaire

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Ketamine+venlafaxine

venlafaxine

Arm Description

one injection of 0.5 mg/kg of kentamine the first day plus venlafaxine (150-375 mg day) during 6 weeks

venlafaxine (150-375 mg day) during 6 weeks

Outcomes

Primary Outcome Measures

Depressive state
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.

Secondary Outcome Measures

Full Information

First Posted
March 15, 2012
Last Updated
February 23, 2017
Sponsor
University Hospital, Grenoble
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1. Study Identification

Unique Protocol Identification Number
NCT01557712
Brief Title
Estimate the Efficiency of the Association of an Injection of Ketamine and the Venlafaxine in the Severe Major Depressive Disorder for Six Weeks
Acronym
KETADEP
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.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
March 2012 (Actual)
Primary Completion Date
January 2017 (Actual)
Study Completion Date
January 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Grenoble

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ketamine+venlafaxine
Arm Type
Experimental
Arm Description
one injection of 0.5 mg/kg of kentamine the first day plus venlafaxine (150-375 mg day) during 6 weeks
Arm Title
venlafaxine
Arm Type
Active Comparator
Arm Description
venlafaxine (150-375 mg day) during 6 weeks
Intervention Type
Drug
Intervention Name(s)
ketamine venlafaxine
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Venlafaxine
Intervention Description
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
Primary Outcome Measure Information:
Title
Depressive state
Description
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.
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Centre hospitalier universitaire
City
Grenoble
ZIP/Postal Code
38000
Country
France

12. IPD Sharing Statement

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