Depression
Conditions
Keywords
Depression, Moods disorders, electroconvulsive therapy
Brief summary
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
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.
Interventions
DEVICEDevice : 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.
DEVICEDevice : sham 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.
Sponsors
Hôpital le Vinatier
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Relapse rate 6 months after remission, defined as the reappearance of a depressive syndrome, measured by a scoring MADRS >15. | 6 months | MADRS will be assessed in each follow-up visit (weekly the first month, fortnightly the second and third month, monthly the following 3 months). |
Secondary
| Measure | 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 |
Countries
France
Outcome results
None listed