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

NCT01557712 | Completed Phase 3 DMC

• 1 other identifier: 1129
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Ketamine+venlafaxine

EXPERIMENTAL

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

Drug: ketamine venlafaxine

venlafaxine

ACTIVE COMPARATOR

venlafaxine (150-375 mg day) during 6 weeks

Drug: Venlafaxine

Interventions

ketamine venlafaxine 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

Ketamine+venlafaxine

Venlafaxine 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

venlafaxine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Grenoble: lead

Study Sites (1)

Centre hospitalier universitaire

Grenoble, 38000, France

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Venlafaxine Hydrochloride

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Phenethylamines; Ethylamines; Amines; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Lipids

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2012
• First Posted: March 19, 2012
• Study Start: March 1, 2012
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: February 24, 2017

Record last verified: 2017-01

Locations

FR (1)