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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2011 by Centre Hospitalier Universitaire de Besancon.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
H. Lundbeck A/S
Information provided by (Responsible Party):
Emmanuel Haffen, Centre Hospitalier Universitaire de Besancon
ClinicalTrials.gov Identifier:
NCT01428804
First received: September 2, 2011
Last updated: September 5, 2011
Last verified: September 2011
  Purpose

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.


Condition Intervention Phase
Resistant Major Depression
Device: transcranial Direct Current Stimulation (tDCS)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pilot Study of Feasibility of the Effect of Treatment With tDCS in Patients Suffering From Resistant Depression

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Besancon:

Primary Outcome Measures:
  • 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] ] [ Designated as safety issue: No ]
    The changes in MADRS will constitute the major research outcome measure used to assess response to tDCS


Secondary Outcome Measures:
  • HDRS-21 [ Time Frame: [time frame: baseline, 1 wk, 2 wk, 4wk, 12 wk, 24 wk] ] [ Designated as safety issue: No ]
  • BDI-13 [ Time Frame: [time frame: baseline, 1 wk, 2 wk, 4wk, 12 wk, 24 wk] ] [ Designated as safety issue: No ]
  • subscores for anxiety depression scale from HRDS-21 [ Time Frame: [time frame: baseline, 1 wk, 2 wk, 4wk, 12 wk, 24 wk] ] [ Designated as safety issue: No ]
  • STAI [ Time Frame: [time frame: baseline, 1 wk, 2 wk, 4wk, 12 wk, 24 wk] ] [ Designated as safety issue: No ]

Estimated Enrollment: 24
Study Start Date: June 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Eldith DC - Stimulator (neuroConn GmbH, Ilmenau, Germany)

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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®)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01428804

Contacts
Contact: Emmanuem HAFFEN, Prof. +33381218154 emmanuel.haffen@univ-fcomte.fr

Locations
France
CHU Besancon - Clinical Psychaitric Department Recruiting
Besancon, France, 25000
Sponsors and Collaborators
Emmanuel Haffen
H. Lundbeck A/S
Investigators
Principal Investigator: Emmanuel HAFFEN, Prof. CHU Besancon - Clinical Psychiatric Department
  More Information

No publications provided

Responsible Party: Emmanuel Haffen, PU-PH, Centre Hospitalier Universitaire de Besancon
ClinicalTrials.gov Identifier: NCT01428804     History of Changes
Other Study ID Numbers: DEPRESCO
Study First Received: September 2, 2011
Last Updated: September 5, 2011
Health Authority: France: Committee for the Protection of Personnes
France: Direction Générale de la Santé
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Centre Hospitalier Universitaire de Besancon:
Resistant Major Depression
Mood disorders
tDCS

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 23, 2014