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

Major Depressive Disorder Clinical Trial

— 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01557712
• Other study ID #: 1129
• Status: Completed
• Phase: Phase 3
• First received: March 15, 2012
• Last updated: February 23, 2017
• Start date: March 2012
• Est. completion date: January 2017

Study information

• Verified date: January 2017
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Disease
• Major Depressive Disorder

Intervention

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
• 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

Locations

Country	Name	City	State
France	Centre hospitalier universitaire	Grenoble

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 weeks