An interventional study of Device : Transcranial direct current stimulation and Device : sham Transcranial direct current stimulation in Depression, sponsored by Hôpital le Vinatier. Terminated at 1 site in France. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2019-04-22.
Sponsored by Hôpital le Vinatier · Not applicable, Interventional, and Prevention
While electroconvulsive therapy (ECT) in major depression is effective, high relapse rates and cognitive side effects limit its long-term use. There is no consensus about optimal continuation pharmacological treatments after a ECT course.
Adjunction of tDCS to pharmacological continuation treatment after ECT may decrease relapse rates.
In a prospective, randomized, double blind, controlled, long-term study, investigators assign 40 depressed patients, in remission after ECT course associated to venlafaxine, with lithium adjunction after ECT course, either to tDCS or sham tDCS. Depressive symptoms and cognition were assessed after acute ECT after six months of continuation therapy.
8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.
This study's enrollment of 1 is below the median of 84 across 6,720 interventional studies indexed under Depression.
Browse Depression studies →Hôpital le Vinatier is the lead sponsor of 106 studies on the registry; 41 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The anode will be applied over the F3 area and the cathode over the F4 area. The current dose is 2mA. Electrodes will be 7x5cm in size. The investigators will apply 2 daily, tDCS sessions of 30 minutes, weekly the first month, fortnightly the second and third month, monthly the following 3 months.
Device: Device : Transcranial direct current stimulation
The anode will be applied over the F3 area and the cathode over the F4 area. Electrodes will be 7x5cm in size. The investigators will apply 2 daily, tDCS sessions of 30 minutes, weekly the first month, fortnightly the second and third month, monthly the following 3 months.
Device: Device : sham Transcranial direct current stimulation
The anode will be applied over the F3 area and the cathode over the F4 area. The current dose is 2mA. Electrodes will be 7x5cm in size. The investigators will apply 2 daily, tDCS sessions of 30 minutes, weekly the first month, fortnightly the second and third month, monthly the following 3 months.
The anode will be applied over the F3 area and the cathode over the F4 area. Electrodes will be 7x5cm in size. The investigators will apply 2 daily, tDCS sessions of 30 minutes, weekly the first month, fortnightly the second and third month, monthly the following 3 months.
Relapse rate 6 months after remission, defined as the reappearance of a depressive syndrome, measured by a scoring MADRS >15.
MADRS will be assessed in each follow-up visit (weekly the first month, fortnightly the second and third month, monthly the following 3 months).
Time frame: 6 months
Montreal Cognitive Assesment (MoCA)
Time frame: basal and at 6 months
Scores on Clinical Global Impression (CGI)
Time frame: after remission basal and at 6 months
Time to relapse
Time frame: during 6 months
Plan to share: No
No publications or documents are linked to this record.
This study is terminated, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.
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