Repetitive Transcranial Magnetic Stimulation and Venlafaxine in Depression

Repetitive Transcranial Magnetic Stimulation Efficacy for Major Resistant Depression Compared or Associated With Venlafaxine : a Multicentric Study.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00714090

Enrollment

170

Registered

2008-07-14

Start date

2008-05-31

Completion date

2013-07-31

Last updated

2013-07-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Unipolar Depression

Keywords

repetitive Transcranial Magnetic Stimulation (rTMS), Major depressive disorders, Depression, Venlafaxine

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.

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.

Interventions

OTHERactive 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

OTHERactive 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.

OTHERsham 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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)	2 to 6 weeks

Secondary

Measure	Time frame
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

Countries

France, Monaco

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026