Transcranial Direct Current Stimulation as an add-on Treatment for Resistant Major Depression in Uni- or Bipolar Patients (STICODEP)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2012 by Centre Hospitalier Universitaire de Besancon
Sponsor:
Collaborators:
Centre Hospitalier Universitaire de Besancon
Clinical Investigation Centre for Innovative Technology Network
Clinique de Psychiatrie de l'Adulte - CHU Grenoble (Dr Mircea POLOSAN, Dr David SZEKELY)
CH Le Vinatier - Service de Psychiatrie (Dr Emmanuel POULET)
Centre Hospitalier Guillaume Régnier - Rennes - Service Hospitalo-Universitaire de Psychiatrie ( Pr D.DRAPIER)
EPS Ville-Evrard - Unité de Recherche Clinique (Dr Dominique JANUEL)
Hôpital Civil de Strasbourg - Service de Psychiatrie (Pr G.Bertschy)
Information provided by (Responsible Party):
Emmanuel Haffen, Centre Hospitalier Universitaire de Besancon
ClinicalTrials.gov Identifier:
NCT01644747
First received: July 17, 2012
Last updated: July 18, 2012
Last verified: July 2012
  Purpose

The aim of our study is to investigate the effect of transcranial Direct Current Stimulation (tDCS) applied at the anodal left CDLPF of patients with resistant depression compared to patients treated with conventional therapy. The tDCS is used in add-on drug treatment in resistant depression (antidepressant for unipolar patients and lithium for bipolar patients).

This is a randomized 2-arm parallel, double blind study comparing 2 groups of 60 patients (48 unipolar plus 12 bipolar patients per group): patients treated with sham tDCS and whose medication reference is stabilized for 4 weeks vs. patients treated by active tDCS 10 sessions over five days and whose medication reference is stabilized for 4 weeks. The 120 patients with resistant depression will be selected in the psychiatric department of the University Hospital of different centers (Besançon, Grenoble, Lyon-Le Vinatier, Rennes, Strasbourg and Ville-Evrard). After giving informed consent, patients will be evaluated by a psychiatrist using the Hamilton Depression Rating Scale (HDRS), Montgomery Asberg Depression Rating Scale (MADRS), the STAI and Beck Depression Inventory (BDI) and for bipolar patient only, by the Young Mania Rating Scale (YMRS). The complete assessment takes 50 minutes. A neuropsychologist assessment will be also realized during 20 minutes using the Crossing of Test (COT), the Trail Making Test (TMT), the Isaacs Set Test (IST) and the Cardebat fluency Task.

After locating the left DLPFC, treatment with active tDCS with a current of 2 mA or sham will be directed by 30-minute session. A psychometric assessment will be conducted again at the end of treatment week and 4 weeks, 12 weeks and finally 24 weeks after stopping treatment. The neuropsychologist assessment will be conducted again 4 weeks after the end of 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 SSRIs (Selective Serotonin Reuptake Inhibitors) or SNRIs (Serotonine-Norepinephrine Reuptake Inhibitors) for unipolar patients or with Lithium for bipolar patients stabilized for at least 4 months and 10 sessions of active anodal tDCS at 2 sessions per day (1 morning and 1 afternoon with a gap of 3h) for 5 days with an electric current 2 mA ;
  • a group named G2 and treated by medication with with SSRIs or SNRIs for unipolar patients or with Lithium for bipolar patients stabilized for at least 4 months and sham tDCS.

These two groups are matched for age (+/- 5 years), gender and depression diagnosis (unipolar vs bipolar).

The population of this study will be comprised of patients over age 18 with unipolar or bipolar depressive episode resistant episode characterized by the failure of one antidepressant treatment for depressive episode and treated by medication with SSRIs or SNRIs for unipolar patients or with Lithium for bipolar patients, since at least 4 weeks. The delay of 4 weeks 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 6 research centers. This study was conducted over a period of 36 months.

This study was supporting by a grant from the French Hospital Program of Clinical Reseach (PHRC N/2011-60-2011-A01074-37)


Condition Intervention Phase
Resistant Major Depression
Moods Disorders
Unipolar Disorder
Bipolar Disorder
Device: transcranial Direct Current Stimulation (tDCS) (Eldith DC NeuroConn Stimulator)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: tDCS as an add-on Treatment for Resistant Major Depression in Uni- or Bipolar Patients: a Randomized, Double-blind, Placebo Controlled Study

Resource links provided by NLM:


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

Primary Outcome Measures:
  • change from baseline in HDRS-21 scale [ Time Frame: baseline, 1 wk, 2 wk, 4wk, 12 wk, 24 wk ] [ Designated as safety issue: No ]
    The changes in HDRS-21 will constitute the major research outcome measure used to assess response to tDCS. Response to treatment is defined as a ≥ 50% reduction in the scores of the HDRS. Remission is defined as a HDRS score ≤ 8.


Secondary Outcome Measures:
  • Change from baseline in MADRS, BDI, HAMA, STAI, YMRS [ Time Frame: baseline, 1 wk, 2 wk, 4wk, 12 wk, 24 wk ] [ Designated as safety issue: No ]
    Montgomery and Asberg Depression Rating Scale (MADRS) Beck Depression Inventory-13 (BDI) Subscores for anxiety depression scale from HDRS-21 State-Trait Anxiety Inventory (STAI) Young Mania Rating Scale (YMRS) : only for bipolar patient

  • Change from baseline in COT, TMT, IST and Cardebat fluency task [ Time Frame: baseline, 4wk ] [ Designated as safety issue: No ]
    Crossing of test (COT) Trail Making test (TMT) Isaacs Set Test (IST) Cardebat fluency task


Estimated Enrollment: 120
Study Start Date: July 2012
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: active tDCS
a group named G1 and treated by medication with SSRIs (Selective Serotonin Reuptake Inhibitors) or SNRIs (Serotonine-Norepinephrine Reuptake Inhibitors) for 48 unipolar patients or with Lithium for 12 bipolar patients stabilized for at least 4 months and 10 sessions of active anodal tDCS at 2 sessions per day (1 morning and 1 afternoon with a gap of 3h) for 5 days with an electric current 2 mA.
Device: transcranial Direct Current Stimulation (tDCS) (Eldith DC NeuroConn Stimulator)
After locating the left DLPFC, ttt with active anodal tDCS with a current of 2 mA or sham over the left DLPFC will be directed by 30-minute session. Treatment will occur 2 sessions per day during 5 days per week. Subjects will be monitored during tDCS for any side effects or adverse events.
Other Name: EldithDC-NeuroConn Stimulator (NeuroConn Gmbh, Ilmenau, Germany)
Sham Comparator: sham tDCS
a group named G2 and treated by medication with SSRIs or SNRIs for 48 unipolar patients or with Lithium for 12 bipolar patients stabilized for at least 4 months and sham tDCS.
Device: transcranial Direct Current Stimulation (tDCS) (Eldith DC NeuroConn Stimulator)
After locating the left DLPFC, ttt with active anodal tDCS with a current of 2 mA or sham over the left DLPFC will be directed by 30-minute session. Treatment will occur 2 sessions per day during 5 days per week. Subjects will be monitored during tDCS for any side effects or adverse events.
Other Name: EldithDC-NeuroConn Stimulator (NeuroConn Gmbh, Ilmenau, Germany)

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
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 failed antidepressant treatments for the current depressive episode)
  • HDRS-21 score ≥ 21
  • drug treatment by SSRIs or SNRIs for unipolar patients or with Lithium for bipolar patients for at least 4 weeks
  • right-handed patients
  • without severe progressive somatic pathology (especially tumor diseases, degenerative diseases)
  • without severe cognitive impairment making psychometric evaluation impossible
  • excepted antidepressant or Lithium treatment, psychotropic following are tolerated during the course of the study : hydroxyzin; cyamemazin (up to 100 mg/day) ; hypnotics (imidazopyridin).

Exclusion Criteria:

  • subject treated with antipsychotics or mood stabilizers or anticonvulsants or by ECT or rTMS for the current depressive episode
  • subject resistant to SSRIs or SNRIs for unipolar patients or with Lithium for bipolar patients
  • subject with mixed features
  • pregnancy and/or lactation
  • presence of a specific contraindication for tDCS (e.g., personal history of epilepsy, metallic head implant, cardiac pacemaker)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01644747

Contacts
Contact: Emmanuel HAFFEN, Prof +33381218154 emmanuel.haffen@univ-fcomte.fr
Contact: Magali NICOLIER, PhD +33381219007 mnicolier@chu-besancon.fr

Locations
France
CHRU Besancon - Service de Psychiatrie - Centre Investigation Clinique Innovation Technologique (CIC-IT808) Recruiting
Besancon, France
Contact: Emmanuel HAFFEN, Prof    +33381218154    emmanuel.haffen@univ-fcomte.fr   
Contact: Magali NICOLIER, PhD    +33381219007    mnicolier@chu-besancon.fr   
Principal Investigator: Emmanuel HAFFEN, MD PhD         
CHU Grenoble - Clinique de Psychiatrie de l'Adulte Recruiting
Grenoble, France
Contact: Mircea POLOSAN, MD         
Contact: David SZEKELY, MD       DSzekely@chu-grenoble.fr   
Principal Investigator: David SZEKELY, MD         
CH Le Vinatier - Service de Psychiatrie Recruiting
Lyon, France
Contact: Emmanuel POULET, MD       EMMANUEL.POULET@ch-le-vinatier.fr   
Principal Investigator: Emmanuel POULET, MD         
Centre Hospitalier Guillaume Régnier - Rennes - Service Hospitalo-Universitaire de Psychiatrie Recruiting
Rennes, France
Contact: Dominique DRAPIER, MD PhD       d.drapier@ch-guillaumeregnier.fr   
Principal Investigator: Dominique DRAPIER, MD PhD         
Hôpital Civil de Strasbourg - Service de Psychiatrie Recruiting
Strasbourg, France
Contact: Gilles BERTSCHY, MD PhD       gilles.bertschy@chru-strasbourg.fr   
Principal Investigator: Gilles BERTSCHY, MD PhD         
Etablissement Public de Santé Mentale - Unité de Recherche Clinique Recruiting
Ville Evrard, France
Contact: Dominique JANUEL, MD       d.januel@eps-ville-evrard.fr   
Contact: Alexane STEPHAN       a.stephan@epsve.fr   
Principal Investigator: Dominique JANUEL, MD         
Sponsors and Collaborators
Emmanuel Haffen
Centre Hospitalier Universitaire de Besancon
Clinical Investigation Centre for Innovative Technology Network
Clinique de Psychiatrie de l'Adulte - CHU Grenoble (Dr Mircea POLOSAN, Dr David SZEKELY)
CH Le Vinatier - Service de Psychiatrie (Dr Emmanuel POULET)
Centre Hospitalier Guillaume Régnier - Rennes - Service Hospitalo-Universitaire de Psychiatrie ( Pr D.DRAPIER)
EPS Ville-Evrard - Unité de Recherche Clinique (Dr Dominique JANUEL)
Hôpital Civil de Strasbourg - Service de Psychiatrie (Pr G.Bertschy)
Investigators
Principal Investigator: Emmanuel HAFFEN, MD PhD Centre Hospitalier Universitaire de Besancon
  More Information

No publications provided

Responsible Party: Emmanuel Haffen, MD PhD, Centre Hospitalier Universitaire de Besancon
ClinicalTrials.gov Identifier: NCT01644747     History of Changes
Other Study ID Numbers: STICODEP
Study First Received: July 17, 2012
Last Updated: July 18, 2012
Health Authority: 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
Moods disorders
Unipolar disorder
Bipolar disorder
tDCS

Additional relevant MeSH terms:
Bipolar Disorder
Depressive Disorder, Major
Depressive Disorder
Depression
Mood Disorders
Disease
Affective Disorders, Psychotic
Mental Disorders
Behavioral Symptoms
Pathologic Processes

ClinicalTrials.gov processed this record on September 16, 2014