tDCS in the Prevention of Relapse After Electroconvulsive Therapy

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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tDCS as Continuation Treatment to Sustain Remission After Electroconvulsive Therapy in Depression

Conditions
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Depression

Intervention / Treatment
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* Device: Device : Transcranial direct current stimulation
* Device: Device : sham Transcranial direct current stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18-75 ans Remission (MADRS <10) of a major depressive episode after acute treatment with ECT + venlafaxine Lithium adjunction 48h after the last ECT session No comorbid psychiatric disorder, excluding personality disorder or nicotine dependance. Capacity to consent Sufficient comprehension of the French language Exclusion Criteria: Contra-indications to tDCS Neurologic conditions Severe medical conditions. Pregnancy/breast-feeding. Current use of benzodiazepines or antipsychotics

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: tDCS<br>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<br>* 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.<br>|
| Sham Comparator: Sham tDCS<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Montreal Cognitive Assesment (MoCA) |  | basal and at 6 months | 
| Scores on Clinical Global Impression (CGI) |  | after remission basal and at 6 months | 
| Time to relapse |  | during 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Depression, Moods disorders, electroconvulsive therapy