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

Sponsor

University Hospital, Grenoble (Other)

Overall Status

Completed

CT.gov ID

NCT01557712

Collaborator

(none)

Enrollment

Location

Arms

58.1

Actual Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Major Depressive Disorder	Drug: ketamine venlafaxine Drug: Venlafaxine	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

25 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

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.

Actual Study Start Date :

Mar 1, 2012

Actual Primary Completion Date :

Jan 1, 2017

Actual Study Completion Date :

Jan 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Ketamine+venlafaxine one injection of 0.5 mg/kg of kentamine the first day plus venlafaxine (150-375 mg day) during 6 weeks	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
Active Comparator: venlafaxine venlafaxine (150-375 mg day) during 6 weeks	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

Arm

Intervention/Treatment

Experimental: Ketamine+venlafaxine

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

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

Active Comparator: venlafaxine

venlafaxine (150-375 mg day) during 6 weeks

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

Outcome Measures

Primary Outcome Measures

Depressive state [6 weeks]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centre hospitalier universitaire	Grenoble		France	38000

Sponsors and Collaborators

University Hospital, Grenoble

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital, Grenoble

ClinicalTrials.gov Identifier:

NCT01557712

Other Study ID Numbers:

1129

First Posted:

Mar 19, 2012

Last Update Posted:

Feb 24, 2017

Last Verified:

Jan 1, 2017

Additional relevant MeSH terms:

Depressive Disorder

Depression

Depressive Disorder, Major

Ketamine

Venlafaxine Hydrochloride

Study Results

No Results Posted as of Feb 24, 2017