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

Grenoble Alpes University Hospital Center (CHU)

Status and phase

Completed

Phase 3

Conditions

Major Depressive Disorder

Treatments

Drug: ketamine venlafaxine

Drug: Venlafaxine

Study type

Interventional

Funder types

Other

Identifiers

NCT01557712

1129

Details and patient eligibility

About

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.

Enrollment

25 patients

Sex

All

Ages

18+ years old

Volunteers

No 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.