Repetitive Transcranial Magnetic Stimulation and Venlafaxine in Depression
1 other identifier
interventional
170
2 countries
18
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started May 2008
Longer than P75 for phase_3
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2008
CompletedFirst Submitted
Initial submission to the registry
July 10, 2008
CompletedFirst Posted
Study publicly available on registry
July 14, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2013
CompletedJuly 19, 2013
July 1, 2013
4.2 years
July 10, 2008
July 18, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (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)
2 to 6 weeks
Secondary Outcomes (5)
Onset of action for remission and response (HDRS-17 diminution > 50%)
2 to 6 weeks
Anxiety will be assessed using the Covi Anxiety Scale.
2 to 6 weeks
Side effects will be assessed using the UKU Scale.
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)
2 to 6 weeks
Onset of action using the Clinical Global Impressions scale (CGI)
2 to 6 weeks
Study Arms (3)
A
ACTIVE COMPARATORDouble active comparator : venlafaxine (150 mg/day) and rTMS (5 times/week)
B
EXPERIMENTALactive rTMS (5 times/week) and sham venlafaxine (150 mg/day)
C
SHAM COMPARATORsham rTMS (5 times/week) and active venlafaxine (150 mg/day)
Interventions
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
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.
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.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Club rTMS et Psychiatrielead
- Ministry of Health, Francecollaborator
- Wyeth is now a wholly owned subsidiary of Pfizercollaborator
Study Sites (18)
C.H.U. Saint-Jacques - Service de Psychiatrie de l'Adulte
Besançon, 25000, France
C.H. Le Vinatier - EA 4166, UCB Lyon 1 - Department of Psychiatry - Service du Pr d'AMATO
Bron, 69500, France
C.H.U. Gabriel Montpied - Service de Psychiatrie et Psychologie Médicale - CMP A
Clermont-Ferrand, 63000, France
Hôpital Louis Mourier
Colombes, 92700, France
C.H.U. Dijon, Hôpital Général - Service de Psychiatrie et d'Addictologie
Dijon, 21000, France
C.H.U. de Grenoble, Hôpital sud - Département de Psychiatrie
Grenoble, 38000, France
ASM Limoux
Lézignan-Corbières, 11200, France
Hôpital Fontan - C.H.R.U. Lille
Lille, 59000, France
C.H. Sainte Marguerite
Marseille, 13000, France
CHU - Hôpital La Colombière
Montpellier, 34000, France
Hôpital Pasteur - CHU Nice
Nice, 06000, France
Hôpital Sainte Anne - Service Hospitalo-Universitaire de Santé Mentale et de Thérapeutique
Paris, 75014, France
C.H.U. de POITIERS
Poitiers, 86000, France
C.H.U. - C.H. Guillaume Régnier
Rennes, 35000, France
C.H.U. Charles Nicolle - Service Hospitalo-Universitaire de Psychiatrie
Rouen, 76000, France
EPS de Ville Evrard - Unité de Saint-Denis
Saint-Denis, 93200, France
CHU St Etienne - Hôpital Nord
Saint-Etienne, 42055, France
Centre Hospitalier Princesse Grace
Monaco, 98000, Monaco
Related Publications (1)
Brunelin J, Jalenques I, Trojak B, Attal J, Szekely D, Gay A, Januel D, Haffen E, Schott-Pethelaz AM, Brault C; STEP Group; Poulet E. The efficacy and safety of low frequency repetitive transcranial magnetic stimulation for treatment-resistant depression: the results from a large multicenter French RCT. Brain Stimul. 2014 Nov-Dec;7(6):855-63. doi: 10.1016/j.brs.2014.07.040. Epub 2014 Aug 7.
PMID: 25192980DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Medical Doctor
Study Record Dates
First Submitted
July 10, 2008
First Posted
July 14, 2008
Study Start
May 1, 2008
Primary Completion
July 1, 2012
Study Completion
July 1, 2013
Last Updated
July 19, 2013
Record last verified: 2013-07