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

NCT ID: NCT01557712

Last Updated: 2017-02-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-03-31
• Study Completion Date: 2017-01-31

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.

Conditions

Major Depressive Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Ketamine+venlafaxine

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

Group Type: EXPERIMENTAL

ketamine venlafaxine

Intervention Type: DRUG

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

venlafaxine (150-375 mg day) during 6 weeks

Group Type: ACTIVE_COMPARATOR

Venlafaxine

Intervention Type: DRUG

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

Interventions

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

Intervention Type: 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

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Grenoble

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Centre hospitalier universitaire

Grenoble, , France

Countries

France

Other Identifiers

1129

Identifier Type: -

Identifier Source: org_study_id