Status:
COMPLETED
Study of Transcranial Direct Current Stimulation (tDCS) as add-on Treatment for Resistant Major Depression
Lead Sponsor:
Centre Hospitalier Universitaire de Besancon
Collaborating Sponsors:
H. Lundbeck A/S
Conditions:
Resistant Major Depression
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of the study is to investigate the effect of tDCS applied at the anodic left DLPFC of patients with resistant depression compared to patients treated with conventional therapy. The tDCS is...
Detailed Description
The aim of our study is to investigate the effect of tDCS applied at the anodic left dorsolateral prefrontal cortex (DLPFC)of patients with resistant depression compared to patients treated with conve...
Eligibility Criteria
Inclusion
- subject whose MDD are single or recurrent without psychotic features according to DSM-IV-TR
- subject with a diagnosis of resistant major depression (1 or 2 failed antidepressant treatments for the current depressive episode)
- MADRS score ≥ 25
- subjects with drug treatment by escitalopram (Seroplex®) for at least one month
- right-handed patients
- without severe progressive somatic pathology (especially tumor diseases, degenerative diseases)
- without severe cognitive impairment making psychometric evaluation impossible
- excepted antidepressant treatment, psychotropic following are tolerated during the course of the study : benzodiazepine anxiolytics (up to 20mg/day diazepam equivalent) ; hydroxyzine (up to 50 mg/day) ; cyamemazine (up to 50 mg/day) ; hypnotics (imidazopyridine up to 7.5 mg/day).
Exclusion
- subject treated with antipsychotics or mood stabilizers
- subjects resistant to escitalopram (Seroplex®)
Key Trial Info
Start Date :
June 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2013
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT01428804
Start Date
June 1 2011
End Date
July 1 2013
Last Update
August 23 2016
Active Locations (1)
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1
CHU Besancon - Clinical Psychaitric Department
Besançon, France, France, 25000