NCT01428804

Brief Summary

The purpose of the study is to investigate the effect of tDCS applied at the anodic left DLPFC of patients with resistant depression compared to patients treated with conventional therapy. The tDCS is used in add-on drug treatment with antidepressants of reference in resistant depression.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jun 2011

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2011

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 2, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 5, 2011

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

August 23, 2016

Status Verified

August 1, 2016

Enrollment Period

2.1 years

First QC Date

September 2, 2011

Last Update Submit

August 22, 2016

Conditions

Resistant Major Depression

Keywords

Resistant Major DepressionMood disorderstDCS

Outcome Measures

Primary Outcomes (1)

  • MADRS [time frame: baseline, 1 wk, 2 wk, 4wk, 12 wk, 24 wk]

    The changes in MADRS will constitute the major research outcome measure used to assess response to tDCS

    [time frame: baseline, 1 wk, 2 wk, 4wk, 12 wk, 24 wk]

Secondary Outcomes (4)

  • HDRS-21

    [time frame: baseline, 1 wk, 2 wk, 4wk, 12 wk, 24 wk]

  • BDI-13

    [time frame: baseline, 1 wk, 2 wk, 4wk, 12 wk, 24 wk]

  • subscores for anxiety depression scale from HRDS-21

    [time frame: baseline, 1 wk, 2 wk, 4wk, 12 wk, 24 wk]

  • STAI

    [time frame: baseline, 1 wk, 2 wk, 4wk, 12 wk, 24 wk]

Study Arms (2)

active tDCS

ACTIVE COMPARATOR

a group named G1 and treated by medication with escitalopram (Seroplex®) stabilized for at least 1 month and 10 sessions of tDCS anode active at 2 sessions per day (1 morning and 1 afternoon) for 5 days with an electric current 2 mA

Device: transcranial Direct Current Stimulation (tDCS)

sham tDCS

SHAM COMPARATOR

a group named G2 and treated by medication with escitalopram (Seroplex®) stabilized for at least 1 month and sham tDCS.

Device: transcranial Direct Current Stimulation (tDCS)

Interventions

transcranial Direct Current Stimulation (tDCS)DEVICE

Device: Eldith DC-Stimulator real or sham tDCS for 20 minutes at 2mA intensity over the left DLPFC (F3 according to the 10-20 system) Other Name: Eldith DC - Stimulator (neuroConn GmbH, Ilmenau, Germany)

Also known as: Eldith DC - Stimulator (neuroConn GmbH, Ilmenau, Germany)
active tDCSsham tDCS

Eligibility Criteria

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

You may qualify if:

  • subject whose MDD are single or recurrent without psychotic features according to DSM-IV-TR
  • subject with a diagnosis of resistant major depression (1 or 2 failed antidepressant treatments for the current depressive episode)
  • MADRS score ≥ 25
  • subjects with drug treatment by escitalopram (Seroplex®) for at least one month
  • right-handed patients
  • without severe progressive somatic pathology (especially tumor diseases, degenerative diseases)
  • without severe cognitive impairment making psychometric evaluation impossible
  • excepted antidepressant treatment, psychotropic following are tolerated during the course of the study : benzodiazepine anxiolytics (up to 20mg/day diazepam equivalent) ; hydroxyzine (up to 50 mg/day) ; cyamemazine (up to 50 mg/day) ; hypnotics (imidazopyridine up to 7.5 mg/day).

You may not qualify if:

  • subject treated with antipsychotics or mood stabilizers
  • subjects resistant to escitalopram (Seroplex®)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Besancon - Clinical Psychaitric Department

Besançon, France, 25000, France

Location

Related Publications (1)

  • Bennabi D, Nicolier M, Monnin J, Tio G, Pazart L, Vandel P, Haffen E. Pilot study of feasibility of the effect of treatment with tDCS in patients suffering from treatment-resistant depression treated with escitalopram. Clin Neurophysiol. 2015 Jun;126(6):1185-1189. doi: 10.1016/j.clinph.2014.09.026. Epub 2014 Oct 5.

    PMID: 25454337RESULT

MeSH Terms

Conditions

Mood Disorders

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Study Officials

  • Emmanuel HAFFEN, Prof.

    CHU Besancon - Clinical Psychiatric Department

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 2, 2011

First Posted

September 5, 2011

Study Start

June 1, 2011

Primary Completion

July 1, 2013

Study Completion

July 1, 2013

Last Updated

August 23, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)