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Assessing Repetitive Transcranial Magnetic Stimulation as a Treatment for Refractory Depression (rTMS)

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ClinicalTrials.gov Identifier: NCT00190216
Recruitment Status : Terminated (terminated)
First Posted : September 19, 2005
Last Update Posted : November 8, 2007
Information provided by:

Study Description
Brief Summary:
The hypothesis of this study was that transcranial magnetic stimulation (TMS) focused on hyperfunctional cerebral areas should be more effective in treating depressive symptoms than stimulations not taking into account the functional specificity of the patient. The goal was to compare the effects of "guided" TMS, using neuroimaging to guide TMS on dysfunctional cortical regions individually detected by neuroimaging, with "standard TMS", as used in most studies, over the left prefrontal cortex, and with sham TMS, in patients with resistant depression.

Condition or disease Intervention/treatment Phase
Depression Device: Magnetic stimulator Phase 3

Detailed Description:

The objectives of the study were :

  • To localize the site of lowest frontal activity in each patient with resistant depression, using PET to measure regional cerebral metabolic rates for glucose (rCMRGlu).
  • To demonstrate that high-frequency TMS (10Hz) guided on that site is more effective than standard or sham TMS, in resistant depressed patients, using a doubled blind controlled procedure.
  • To assess the effects of TMS on regional cerebral metabolism using rCMRGlu PET after 10 sessions of TMS treatments.

Depressed patients meeting DSM-IV criteria for Major Depressive Disorder, aged between 18 and 55, have been included. They met criteria for depression resistant to antidepressant drugs They were randomised in 3 groups: guided prefrontal TMS, standard left prefrontal and sham left prefrontal TMS.

rTMS was administered daily on working days, for two weeks. Ten stimuli per second (10Hz) were applied in 20 courses so that patients received 1600 stimuli per day. Guided TMS was on a prefrontal target corresponding to the highest statistically significant hyperfunctional cluster determined with rCMRGlu PET. Standard stimulation was left pre-frontal, 5 cm anterior to the optimal stimulation point of the abductor pollices brevis. Stimulation strength was chosen at 90% relative to motor threshold. Sham rTMS used a procedure identical to the real standard treatment, but using a sham coil.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Assessing Repetitive Transcranial Magnetic Stimulation as a Treatment for Refractory Depression
Study Start Date : December 2001
Study Completion Date : October 2007
Arms and Interventions

Arm Intervention/treatment
Experimental: A Device: Magnetic stimulator

Outcome Measures

Primary Outcome Measures :
  1. The primary outcome will be measured at 2 weeks, using depression scales scores : Hamilton depression rating scale, and Montgomery and Asberg Depression Rating Scale [ Time Frame: at 2 weeks ]

Secondary Outcome Measures :
  1. Depressive psychomotor retardation will be assessed at 2 weeks [ Time Frame: at 2 weeks ]
  2. All depression measures will be assessed at 4 weeks, 2 weeks after the end of the trial to evaluate the lasting effects. [ Time Frame: at 4 weeks, 2 weeks after the end of the trial ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Major depression (according to DSM-IV)resistant to at least two medical antidepressant treatment of different pharmacological action, prescribed for at least one month each at an effective dosage, without therapeutical result.
  • Hospitalisation in the service of an investigator
  • Informed consent signed

Exclusion Criteria:

  • Presence of metallic parts inside the body (pace-maker, vascular clip, cardiac valve, prothesis...)
  • Severe somatic or central nervous system disease
  • Familial history of comitiality
  • Pregnancy
Contacts and Locations

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): NCT00190216

Albert Chenevier Hospital, Department of psychiatry
Creteil, France, 94000
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Institut National de la Santé Et de la Recherche Médicale, France
International Atomic Energy Agency
Principal Investigator: Marie-Laure PAILLERE MARTINOT, MD; PhD Assistance Publique - Hôpitaux de Paris
More Information

ClinicalTrials.gov Identifier: NCT00190216     History of Changes
Other Study ID Numbers: AOM98099
First Posted: September 19, 2005    Key Record Dates
Last Update Posted: November 8, 2007
Last Verified: July 2005

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Resistant depression
Transcranial Magnetic Stimulation,

Additional relevant MeSH terms:
Depressive Disorder
Depressive Disorder, Treatment-Resistant
Behavioral Symptoms
Mood Disorders
Mental Disorders