tDCS as an add-on Treatment for Resistant Major Depression in Uni- or Bipolar Patients
Condition: Resistant Depression; Moods Disorders; Unipolar Depression; Bipolar Disorder
MeSH terms: Depression; Depressive Disorder; Bipolar Disorder; Mood Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim 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 stabilized for 4 weeks (antidepressant as SSRIs (Selective Serotonin Reuptake
      Inhibitors) or SNRIs (Serotonine-Norepinephrine Reuptake Inhibitors) for unipolar patients
      and lithium for bipolar patients). 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.

      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 will be selected in the psychiatric
      department of the University Hospital of different centers and the two groups are matched for
      age (+/- 5 years), gender and depression diagnosis (unipolar vs bipolar).

      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, 12 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.

      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)
    


Intervention name(s): transcranial Direct Current Stimulation (tDCS) (Eldith DC NeuroConn Stimulator)
Intervention type(s): Device
Intervention description(s): 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 intervention name(s): EldithDC-NeuroConn Stimulator (NeuroConn Gmbh, Ilmenau, Germany)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Resistant Depression; Moods disorders; Unipolar depression; Bipolar disorder; tDCS