Major Depressive Disorder
Conditions
Keywords
depression, Repetitive Transcranial Magnetic Stimulation, tolerability, efficiency, TMS, refractory
Brief summary
number of center : 1 * duration of study : 24 months * recruitement time : 23 months * Aim :Principal Evaluate the interest of maintenance rTMS in a one-year double blind randomized controlled study for TRD patients. Secondary Evaluate the impact of rTMS on cognitive functions.
Detailed description
The study involves 40 TRD patients in a single site trial which consisted of two phases: an acute phase (phase I) in which all the participants receive active high-frequency stimulation during 4 blocks of five consecutive working days (Monday to Friday) in an open-label design and a maintenance phase (phase II) in which responders (\> 49% HDRS-17 reduction from baseline) at the end of the phase I are randomized in two arms with sham or active high-frequency rTMS maintenance treatment for the eleven following months. The rhythm of rTMS sessions in this maintenance phase is gradually reduced as follows: 3 sessions per week for 2 weeks, 2 session per week for the 2 following weeks, 1 session per week the third (M3) and fourth month (M4) and then 1 session every fortnight the last eight months (M5 to M12).
Interventions
DEVICERepetitive Transcranial Magnetic Stimulation
Repetitive Transcranial Magnetic Stimulation
Sponsors
Centre hospitalier de Ville-Evrard, France
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* TRD stage I Thase-Rush * HDRS + or = 18 * Patients age 18 to 70 years. * Negative pregnancy test and contraception for women. * Informed Consent
Exclusion criteria
* Patient was treated with mood stabilizer in the previous week * Other disorder on axis I of the DSM IV than depressive disorder. * Patient with an addiction problem other than tobacco and caféine * antécedent of Epilepsy ,other neurological pathology and intra cranial metal diapositive or pacemaker * Previous history of head trauma the previous two years. * intracranial hypertension. * not affiliated to the social security Patient * patient under constraint hospitalisation * Under legal protection measure
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 'Hamilton depression rating scale (HDRS) | one years | The efficacy variables included the HDRS-17 item scores, the CGI changes, the Visual Analog Scale (VAS), the Beck Depression Inventory (BDI) and the Hospital Anxiety Depression (HAD). The subjective assessment performed with the VAS consisted of a 100-mm horizontal line oriented with anchors placed at both poles for reassured, sadness, anxiety, and relief. The patients are asked to mark a spot along this line that best indicated the magnitude of their state for each item. |
Countries
France
Contacts
Primary ContactDominique januel, MD.Phd
Outcome results
None listed