Study of Transcranial Direct Current Stimulation (tDCS) as add-on Treatment for Resistant Major Depression (DEPRESCO)

August 22, 2016 updated by: Centre Hospitalier Universitaire de Besancon

Pilot Study of Feasibility of the Effect of Treatment With tDCS in Patients Suffering From Resistant Depression

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The aim of our study is to investigate the effect of tDCS applied at the anodic left dorsolateral prefrontal cortex (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.

This is a randomized 2-arm parallel, double blind study comparing 2 groups of 12 patients: patients treated with sham tDCS and whose medication reference is stabilized for a month vs. patients treated by active tDCS 10 sessions over five days and whose medication reference is stabilized for a month. The 24 patients with resistant depression will be selected in the psychiatric department of the University Hospital of Besançon. After giving informed consent, patients will be evaluated by a psychiatrist using the Montgomery Asberg Depression Rating Scale (MADRS), the Hamilton Depression Rating Scale (HDRS), State-Trait Anxiety Inventory (STAI) and Beck Depression Inventory (BDI). The complete assessment takes 40 minutes.

After locating the left DLPFC, treatment with active tDCS with a current of 2 mA or sham will be directed by 20-minute session. A psychometric assessment will be conducted again at the end of treatment week and one month, three months and finally six months after stopping treatment. Scales of comfort and acceptability will also be proposed to the patient to determine whether any gene is caused by this treatment.

This study will include two parallel arms:

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

These two groups are matched for age (+/- 5 years) and gender. The population of this study will be comprised of patients over age 18 with unipolar depressive episode resistant episode characterized by the failure of two antidepressant treatments for depressive episode and treated by medication with escitalopram (Seroplex®) (20 mg/day), since at least 1 month. The delay of one month is a minimum to observe a non-response. Moreover, in term of ethical point of view, it's difficult to wait 6 to 8 weeks to observe the non-response to treatment.

These people will be recruited on a voluntary basis, after notification and consent in the research center, the Psychiatry Clinical Department of the University Hospital of Besançon. This study was conducted over a period of 15 months.

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Besancon, France, 25000
        • CHU Besancon - Clinical Psychaitric Department

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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).

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: active tDCS
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)
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)
Other Names:
  • Eldith DC - Stimulator (neuroConn GmbH, Ilmenau, Germany)
Sham Comparator: sham tDCS
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)
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)
Other Names:
  • Eldith DC - Stimulator (neuroConn GmbH, Ilmenau, Germany)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MADRS [time frame: baseline, 1 wk, 2 wk, 4wk, 12 wk, 24 wk]
Time Frame: [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 Outcome Measures

Outcome Measure
Time Frame
HDRS-21
Time Frame: [time frame: baseline, 1 wk, 2 wk, 4wk, 12 wk, 24 wk]
[time frame: baseline, 1 wk, 2 wk, 4wk, 12 wk, 24 wk]
BDI-13
Time Frame: [time frame: baseline, 1 wk, 2 wk, 4wk, 12 wk, 24 wk]
[time frame: baseline, 1 wk, 2 wk, 4wk, 12 wk, 24 wk]
subscores for anxiety depression scale from HRDS-21
Time Frame: [time frame: baseline, 1 wk, 2 wk, 4wk, 12 wk, 24 wk]
[time frame: baseline, 1 wk, 2 wk, 4wk, 12 wk, 24 wk]
STAI
Time Frame: [time frame: baseline, 1 wk, 2 wk, 4wk, 12 wk, 24 wk]
[time frame: baseline, 1 wk, 2 wk, 4wk, 12 wk, 24 wk]

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Besancon

Collaborators

H. Lundbeck A/S

Investigators

  • Principal Investigator: Emmanuel HAFFEN, Prof., CHU Besancon - Clinical Psychiatric Department

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (Actual)

July 1, 2013

Study Completion (Actual)

July 1, 2013

Study Registration Dates

First Submitted

September 2, 2011

First Submitted That Met QC Criteria

September 2, 2011

First Posted (Estimate)

September 5, 2011

Study Record Updates

Last Update Posted (Estimate)

August 23, 2016

Last Update Submitted That Met QC Criteria

August 22, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DEPRESCO

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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