tDCS in the Prevention of Relapse After Electroconvulsive Therapy

Not Applicable

Terminated

• Conditions: Depression

• Registration Number: NCT02886858
• Lead Sponsor: Hôpital le Vinatier

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.

Study Timeline

• Study First Submitted: 2016-08-29
• Study First Submitted QC: 2016-08-31
• Study First Posted: 2016-09-01
• Study Start: 2017-02-13
• Status Verified: 2019-04
• Primary Completion: 2019-04-19
• Study Completion: 2019-04-19
• Last Update Submitted: 2019-04-19
• Last Update Posted: 2019-04-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Time to relapse	during 6 months
Montreal Cognitive Assesment (MoCA)	basal and at 6 months
Scores on Clinical Global Impression (CGI)	after remission basal and at 6 months

Trial Locations

Locations (1)

Centre Hospitalier Le Vinatier; 🇫🇷 Bron, Rhône Alpes, France