NCT02886858

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for not_applicable depression

Timeline
Completed

Started Feb 2017

Typical duration for not_applicable depression

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 29, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 1, 2016

Completed
6 months until next milestone

Study Start

First participant enrolled

February 13, 2017

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 19, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 19, 2019

Completed
Last Updated

April 22, 2019

Status Verified

April 1, 2019

Enrollment Period

2.2 years

First QC Date

August 29, 2016

Last Update Submit

April 19, 2019

Conditions

Depression

Keywords

DepressionMoods disorderselectroconvulsive therapy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • 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

Study Arms (2)

tDCS

EXPERIMENTAL

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: Device : Transcranial direct current stimulation

Sham tDCS

SHAM COMPARATOR

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.

Device: Device : sham Transcranial direct current stimulation

Interventions

Device : Transcranial direct current stimulationDEVICE

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.

tDCS
Device : sham Transcranial direct current stimulationDEVICE

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.

Sham tDCS

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Contra-indications to tDCS
  • Neurologic conditions
  • Severe medical conditions.
  • Pregnancy/breast-feeding.
  • Current use of benzodiazepines or antipsychotics

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Le Vinatier

Bron, Auvergne-Rhône-Alpes, 69678, France

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • GALVAO FILIPE, PH

    CH LE VINATIER

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 29, 2016

First Posted

September 1, 2016

Study Start

February 13, 2017

Primary Completion

April 19, 2019

Study Completion

April 19, 2019

Last Updated

April 22, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)