tDCS in the Prevention of Relapse After Electroconvulsive Therapy

Hôpital le Vinatier1 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

Conditions

Depression

Interventions

Device : Transcranial direct current stimulationDEVICE

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 : sham Transcranial direct current stimulationDEVICE

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Centre Hospitalier Le Vinatier

Bron, Auvergne-Rhône-Alpes, France

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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