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

This study has been terminated.
(terminated)
Sponsor:
Collaborators:
Institut National de la Santé Et de la Recherche Médicale, France
International Atomic Energy Agency
Information provided by:
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00190216
First received: September 13, 2005
Last updated: November 6, 2007
Last verified: July 2005
  Purpose

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 Intervention Phase
Depression
Device: Magnetic stimulator
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Assessing Repetitive Transcranial Magnetic Stimulation as a Treatment for Refractory Depression

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • 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:
  • Depressive psychomotor retardation will be assessed at 2 weeks [ Time Frame: at 2 weeks ]
  • 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 ]

Enrollment: 60
Study Start Date: December 2001
Study Completion Date: October 2007
Arms Assigned Interventions
Experimental: A Device: Magnetic stimulator

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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00190216

Locations
France
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
Investigators
Principal Investigator: Marie-Laure PAILLERE MARTINOT, MD; PhD Assistance Publique - Hôpitaux de Paris
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00190216     History of Changes
Other Study ID Numbers: AOM98099, P000606
Study First Received: September 13, 2005
Last Updated: November 6, 2007
Health Authority: France: Ministry of Health

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

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 28, 2014