tDCS in the Prevention of Relapse After Electroconvulsive Therapy

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02886858
• Other study ID #: 2016-A00824-47
• Status: Terminated
• Phase: N/A
• Start date: February 13, 2017
• Est. completion date: April 19, 2019

Study information

• Verified date: April 2019
• Source: Hôpital le Vinatier
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: April 19, 2019
• Est. primary completion date: April 19, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Device:
• Device : 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.
• Device : 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.

Locations

Country	Name	City	State
France	Centre Hospitalier Le Vinatier	Bron	Rhône Alpes

Sponsors (1)

Lead Sponsor	Collaborator
Hôpital le Vinatier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Montreal Cognitive Assesment (MoCA)		basal and at 6 months
Secondary	Scores on Clinical Global Impression (CGI)		after remission basal and at 6 months
Secondary	Time to relapse		during 6 months