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

Depression Clinical Trial

Official title:

Assessing Repetitive Transcranial Magnetic Stimulation as a Treatment for Refractory Depression

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00190216
• Other study ID #: AOM98099
• Secondary ID: P000606
• Status: Terminated
• Phase: Phase 3
• First received: September 13, 2005
• Last updated: November 6, 2007
• Start date: December 2001
• Est. completion date: October 2007

Study information

• Verified date: July 2005
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 60
• Est. completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Treatment-Resistant

Intervention

Device:
• Magnetic stimulator

Locations

Country	Name	City	State
France	Albert Chenevier Hospital, Department of psychiatry	Creteil

Sponsors (3)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	Institut National de la Santé Et de la Recherche Médicale, France, International Atomic Energy Agency

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome will be measured at 2 weeks, using depression scales scores : Hamilton depression rating scale, and Montgomery and Asberg Depression Rating Scale		at 2 weeks
Secondary	Depressive psychomotor retardation will be assessed at 2 weeks		at 2 weeks
Secondary	All depression measures will be assessed at 4 weeks, 2 weeks after the end of the trial to evaluate the lasting effects.		at 4 weeks, 2 weeks after the end of the trial