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Completed

NCT Number: NCT00714090

Repetitive Transcranial Magnetic Stimulation and Venlafaxine in Depression

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.

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Key information

Conditions

Unipolar Depression Behavior Behavioral Symptoms Depression Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

C.H.U. Saint-Jacques - Service de Psychiatrie de l'Adulte, Besançon, France

Loading trial locations.

About this study

rTMS parameters : Intensity of 120% of individually determined motor threshold; frequency : 1 Hz; 360 impulsions; on period : 1 min; off period : 30 s.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

active venlafaxine and active rTMS-repetitive transcranial magnetic stimulator, Inomed and Alpine Biomed

Other

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

active rTMS -repetitive transcranial magnetic stimulator, Inomed and Alpine Biomed and sham venlafaxine

Other

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 rTMS- repetitive transcranial magnetic stimulator, Inomed and Alpine Biomed and active venlafaxine

Other

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 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)

    Time frame: 2 to 6 weeks

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Club rTMS et Psychiatrie

Other

Collaborators

  • Ministry of Health, France
  • Wyeth is now a wholly owned subsidiary of Pfizer

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2012
Study completion
2013
First posted
Jul 14, 2008
Registry last updated
Jul 19, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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