Repetitive Transcranial Magnetic Stimulation and Venlafaxine in Depression
July 18, 2013 updated by: Dr Emmanuel POULET, Club rTMS et Psychiatrie
Repetitive Transcranial Magnetic Stimulation Efficacy for Major Resistant Depression Compared or Associated With Venlafaxine : a Multicentric Study.
The purpose of this study is to assess the efficacy of add-on therapy with repetitive Transcranial Magnetic Stimulation (rTMS) and venlafaxine in the treatment of major depressive disorders compared to venlafaxine only (the optimal medication) and to rTMS only.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
- Other: active venlafaxine and active rTMS-repetitive transcranial magnetic stimulator, Inomed and Alpine Biomed
- Other: active rTMS -repetitive transcranial magnetic stimulator, Inomed and Alpine Biomed and sham venlafaxine
- Other: sham rTMS- repetitive transcranial magnetic stimulator, Inomed and Alpine Biomed and active venlafaxine
Detailed Description
rTMS parameters : Intensity of 120% of individually determined motor threshold; frequency : 1 Hz; 360 impulsions; on period : 1 min; off period : 30 s.
Study Type
Interventional
Enrollment (Actual)
170
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Besançon, France, 25000
- C.H.U. Saint-Jacques - Service de Psychiatrie de l'Adulte
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Bron, France, 69500
- C.H. Le Vinatier - EA 4166, UCB Lyon 1 - Department of Psychiatry - Service du Pr d'AMATO
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Clermont Ferrand, France, 63000
- C.H.U. Gabriel Montpied - Service de Psychiatrie et Psychologie Médicale - CMP A
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Colombes, France, 92700
- Hôpital Louis Mourier
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Dijon, France, 21000
- C.H.U. Dijon, Hôpital Général - Service de Psychiatrie et d'Addictologie
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Grenoble, France, 38000
- C.H.U. de Grenoble, Hôpital sud - Département de Psychiatrie
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Lille, France, 59000
- Hôpital Fontan - C.H.R.U. Lille
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Lézignan-Corbières, France, 11200
- ASM Limoux
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Marseille, France, 13000
- C.H. Sainte Marguerite
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Montpellier, France, 34000
- CHU - Hôpital La Colombière
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Nice, France, 06000
- Hopital Pasteur - Chu Nice
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Paris, France, 75014
- Hôpital Sainte Anne - Service Hospitalo-Universitaire de Santé Mentale et de Thérapeutique
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Poitiers, France, 86000
- C.H.U. de Poitiers
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Rennes, France, 35000
- C.H.U. - C.H. Guillaume Régnier
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Rouen, France, 76000
- C.H.U. Charles Nicolle - Service Hospitalo-Universitaire de Psychiatrie
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Saint-Denis, France, 93200
- EPS de Ville Evrard - Unité de Saint-Denis
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St Etienne cedex, France, 42055
- CHU ST Etienne - Hôpital Nord
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Monaco, Monaco, 98000
- Centre Hospitalier Princesse Grace
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Adults
- Clinical diagnosis of major depressive disorder (DSM-IV)
- HDRS-17 items > 20
- Failure of one antidepressant treatment (efficacious doses for 6 weeks at least)
Exclusion Criteria:
- I or II bipolar disorder
- Psychotic features
- Failure of one previous venlafaxine treatment
- Addiction comorbidity or schizophrenia comorbidity
- Involuntary hospitalization
- Seizures history
- Pregnancy or breastfeeding
- Somatic comorbidity able to impact on cognitive functions
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
ACTIVE_COMPARATOR: A
Double active comparator : venlafaxine (150 mg/day) and rTMS (5 times/week)
|
active venlafaxine LP 75 mg : 1 capsule per day for 3 days, then 2 per day for 2 to 4 weeks, if necessary 3 per day the next 2 weeks. active rTMS : 5 sessions per week for 2 to 6 weeks
Other Names:
|
|
EXPERIMENTAL: B
active rTMS (5 times/week) and sham venlafaxine (150 mg/day)
|
active rTMS : 5 sessions per week for 2 to 6 weeks sham venlafaxine LP 75 mg : 1 capsule per day for 3 days, then 2 per day for 2 to 4 weeks, if necessary 3 per day the next 2 weeks.
Other Names:
|
|
SHAM_COMPARATOR: C
sham rTMS (5 times/week) and active venlafaxine (150 mg/day)
|
sham rTMS : 5 sessions per week for 2 to 6 weeks active venlafaxine LP 75 mg : 1 capsule per day for 3 days, then 2 per day for 2 to 4 weeks, if necessary 3 per day the next 2 weeks.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
The primary outcome measure is remission. It will be evaluated using the Hamilton Depression Rating Scale (HDRS-17 < 8)and Montgomery Asberg Depression Rating Scale (MADRS)
Time Frame: 2 to 6 weeks
|
2 to 6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Onset of action for remission and response (HDRS-17 diminution > 50%)
Time Frame: 2 to 6 weeks
|
2 to 6 weeks
|
|
Anxiety will be assessed using the Covi Anxiety Scale.
Time Frame: 2 to 6 weeks
|
2 to 6 weeks
|
|
Side effects will be assessed using the UKU Scale.
Time Frame: 2 to 6 weeks
|
2 to 6 weeks
|
|
Evaluation of depression using 2 other scales : the Montgomery Asberg Depression Rating Scale (MADRS) and the Beck Depression Inventory scale (BDI-13)
Time Frame: 2 to 6 weeks
|
2 to 6 weeks
|
|
Onset of action using the Clinical Global Impressions scale (CGI)
Time Frame: 2 to 6 weeks
|
2 to 6 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Emmanuel POULET, MD, PhD, EA 4615 - SIPAD, Unité de Recherche UCB Lyon 1/CH Le Vinatier - Department of Psychiatry - Service du Pr d'AMATO
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2008
Primary Completion (ACTUAL)
July 1, 2012
Study Completion (ACTUAL)
July 1, 2013
Study Registration Dates
First Submitted
July 10, 2008
First Submitted That Met QC Criteria
July 11, 2008
First Posted (ESTIMATE)
July 14, 2008
Study Record Updates
Last Update Posted (ESTIMATE)
July 19, 2013
Last Update Submitted That Met QC Criteria
July 18, 2013
Last Verified
July 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Mental Disorders
- Mood Disorders
- Depression
- Depressive Disorder
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Psychotropic Drugs
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Antidepressive Agents
- Antidepressive Agents, Second-Generation
- Serotonin and Noradrenaline Reuptake Inhibitors
- Venlafaxine Hydrochloride
Other Study ID Numbers
- SAD-001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.