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Repetitive Transcranial Magnetic Stimulation and Venlafaxine in Depression

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ClinicalTrials.gov Identifier: NCT00714090
Recruitment Status : Completed
First Posted : July 14, 2008
Last Update Posted : July 19, 2013
Sponsor:
Collaborators:
Ministry of Health, France
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by (Responsible Party):
Dr Emmanuel POULET, Club rTMS et Psychiatrie

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Unipolar Depression 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 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 170 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Repetitive Transcranial Magnetic Stimulation Efficacy for Major Resistant Depression Compared or Associated With Venlafaxine : a Multicentric Study.
Study Start Date : May 2008
Actual Primary Completion Date : July 2012
Actual Study Completion Date : July 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: A
Double active comparator : venlafaxine (150 mg/day) and rTMS (5 times/week)
Other: active venlafaxine and active rTMS-repetitive transcranial magnetic stimulator, Inomed and Alpine Biomed

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:
  • venlafaxine, Wyeth
  • repetitive transcranial magnetic stimulator, Inomed
  • repetitive transcranial magnetic stimulator, Alpine Biomed

Experimental: B
active rTMS (5 times/week) and sham venlafaxine (150 mg/day)
Other: active rTMS -repetitive transcranial magnetic stimulator, Inomed and Alpine Biomed and sham venlafaxine
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:
  • repetitive transcranial magnetic stimulator, Inomed
  • repetitive transcranial magnetic stimulator, Alpine Biomed
  • venlafaxine, Wyeth

Sham Comparator: C
sham rTMS (5 times/week) and active venlafaxine (150 mg/day)
Other: sham rTMS- repetitive transcranial magnetic stimulator, Inomed and Alpine Biomed and active venlafaxine
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:
  • repetitive transcranial magnetic stimulator, Inomed
  • repetitive transcranial magnetic stimulator, Alpine Biomed
  • venlafaxine, Wyeth




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Onset of action for remission and response (HDRS-17 diminution > 50%) [ Time Frame: 2 to 6 weeks ]
  2. Anxiety will be assessed using the Covi Anxiety Scale. [ Time Frame: 2 to 6 weeks ]
  3. Side effects will be assessed using the UKU Scale. [ Time Frame: 2 to 6 weeks ]
  4. 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 ]
  5. Onset of action using the Clinical Global Impressions scale (CGI) [ Time Frame: 2 to 6 weeks ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00714090


Locations
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France
C.H.U. Saint-Jacques - Service de Psychiatrie de l'Adulte
Besançon, France, 25000
C.H. Le Vinatier - EA 4166, UCB Lyon 1 - Department of Psychiatry - Service du Pr d'AMATO
Bron, France, 69500
C.H.U. Gabriel Montpied - Service de Psychiatrie et Psychologie Médicale - CMP A
Clermont Ferrand, France, 63000
Hôpital Louis Mourier
Colombes, France, 92700
C.H.U. Dijon, Hôpital Général - Service de Psychiatrie et d'Addictologie
Dijon, France, 21000
C.H.U. de Grenoble, Hôpital sud - Département de Psychiatrie
Grenoble, France, 38000
Hôpital Fontan - C.H.R.U. Lille
Lille, France, 59000
ASM Limoux
Lézignan-Corbières, France, 11200
C.H. Sainte Marguerite
Marseille, France, 13000
CHU - Hôpital La Colombière
Montpellier, France, 34000
Hôpital Pasteur - CHU Nice
Nice, France, 06000
Hôpital Sainte Anne - Service Hospitalo-Universitaire de Santé Mentale et de Thérapeutique
Paris, France, 75014
C.H.U. de POITIERS
Poitiers, France, 86000
C.H.U. - C.H. Guillaume Régnier
Rennes, France, 35000
C.H.U. Charles Nicolle - Service Hospitalo-Universitaire de Psychiatrie
Rouen, France, 76000
EPS de Ville Evrard - Unité de Saint-Denis
Saint-Denis, France, 93200
CHU St Etienne - Hôpital Nord
St Etienne cedex, France, 42055
Monaco
Centre Hospitalier Princesse Grace
Monaco, Monaco, 98000
Sponsors and Collaborators
Club rTMS et Psychiatrie
Ministry of Health, France
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
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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 automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dr Emmanuel POULET, Medical Doctor, Club rTMS et Psychiatrie
ClinicalTrials.gov Identifier: NCT00714090     History of Changes
Other Study ID Numbers: SAD-001
First Posted: July 14, 2008    Key Record Dates
Last Update Posted: July 19, 2013
Last Verified: July 2013
Keywords provided by Dr Emmanuel POULET, Club rTMS et Psychiatrie:
repetitive Transcranial Magnetic Stimulation (rTMS)
Major depressive disorders
Depression
Venlafaxine
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Venlafaxine Hydrochloride
Serotonin and Noradrenaline Reuptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs