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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

NCT01557712 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2017-02-24

No results posted yet for this study

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.

Conditions

Interventions

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

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

Sponsors & Collaborators

  • University Hospital, Grenoble

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2017-01-31
Completion
2017-01-31

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01557712 on ClinicalTrials.gov