Back to resultstDCS in the Prevention of Relapse After Electroconvulsive Therapy
Primary Purpose
Depression
Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Device : Transcranial direct current stimulation
Device : sham Transcranial direct current stimulation
Sponsored by
About this trial
This is an interventional prevention trial for Depression focused on measuring Depression, Moods disorders, electroconvulsive therapy
Eligibility Criteria
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
Sites / Locations
- Centre Hospitalier Le Vinatier
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
tDCS
Sham tDCS
Arm 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.
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.
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Montreal Cognitive Assesment (MoCA)
Scores on Clinical Global Impression (CGI)
Time to relapse
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02886858
Brief Title
tDCS in the Prevention of Relapse After Electroconvulsive Therapy
Official Title
tDCS as Continuation Treatment to Sustain Remission After Electroconvulsive Therapy in Depression
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Terminated
Why Stopped
investigator and sponsor decided by mutual agreement to stop study prematurely
Study Start Date
February 13, 2017 (Actual)
Primary Completion Date
April 19, 2019 (Actual)
Study Completion Date
April 19, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hôpital le Vinatier
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
Depression, Moods disorders, electroconvulsive therapy
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1 (Actual)
8. Arms, Groups, and Interventions
Arm Title
tDCS
Arm Type
Experimental
Arm 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.
Arm Title
Sham tDCS
Arm Type
Sham Comparator
Arm 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.
Intervention Type
Device
Intervention Name(s)
Device : Transcranial direct current stimulation
Intervention 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.
Intervention Type
Device
Intervention Name(s)
Device : sham Transcranial direct current stimulation
Intervention 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.
Primary Outcome Measure Information:
Title
Relapse rate 6 months after remission, defined as the reappearance of a depressive syndrome, measured by a scoring MADRS >15.
Description
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 Outcome Measure Information:
Title
Montreal Cognitive Assesment (MoCA)
Time Frame
basal and at 6 months
Title
Scores on Clinical Global Impression (CGI)
Time Frame
after remission basal and at 6 months
Title
Time to relapse
Time Frame
during 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GALVAO FILIPE, PH
Organizational Affiliation
CH LE VINATIER
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier Le Vinatier
City
Bron
State/Province
Rhône Alpes
ZIP/Postal Code
69678
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
tDCS in the Prevention of Relapse After Electroconvulsive Therapy
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