tDCS in the Prevention of Relapse After Electroconvulsive Therapy

Hôpital le Vinatier

Status: Terminated

Conditions: Depression

Treatments: Device: Device : sham Transcranial direct current stimulation; Device: Device : Transcranial direct current stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT02886858

2016-A00824-47

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 1 patient

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1 participants in 2 patient groups

tDCS

Experimental group

Description:

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.

Treatment:

Device: Device : Transcranial direct current stimulation

Sham tDCS

Sham Comparator group

Description:

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.

Treatment:

Device: Device : sham Transcranial direct current stimulation