Transcranial Direct Current Stimulation for the Treatment of Bipolar Depression
Condition: Depression, Bipolar
MeSH terms: Depression; Depressive Disorder; Bipolar Disorder
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Non-invasive brain stimulation therapies have been increasingly investigated in recent years
      as a treatment for neuropsychiatric disorders, particularly mood disorders. They are
      particularly appealing since many patients are either refractory or present side effects to
      standard pharmacological regimens. TDCS (transcranial direct current stimulation). a novel
      non- pharmacological brain stimulation technique, might help in overcoming some of these
      issues, since it has low cost, high portability and it is relatively easy to use. TDCS
      consists in applying a weak, direct current through two electrodes placed over the scalp; the
      anode and the cathode increasing and decreasing cortical excitability during and beyond the
      period of stimulation. It is also a safe technique with only mild adverse effects described.
      Previous studies, some of them from our group, have described that tDCS is an effective
      technique for major depression. However, the role of tDCS as a treatment for bipolar
      depression (BD) has been insufficiently investigated. Therefore, our aim is to address the
      antidepressant effects of tDCS in BD in a randomized, sham- controlled trial in a refractory
      sample.
    

Detailed description: 
      BD represents the greatest burden on patients with bipolar disorder, since the depressive
      episodes are the most frequent and also particularly associated with suicide 7. BD treatment
      is controversial, with some stricter guidelines recommending only lithium, lamotrigine and
      quetiapine as a first-treatment, whereas others allow the use of antidepressants (which can
      increase manic switch and should be used in association with mood stabilizers) and other
      anticonvulsants and antipsychotics 8. For refractory BD the available level I evidence is
      very scarce, with only seven studies exploring this issue hitherto 9. Therefore, the
      importance of this study proposal is justified considering the burden of the disease, the
      paucity of current therapeutic studies and the promising results presented for tDCS in
      unipolar disorder.
    

Intervention name(s): Sham stimulation; Active stimulation
Intervention type(s): Device; Device
Intervention description(s): For sham tDCS, the device will be turned off after 30 seconds of stimulation.; For active tDCS, we will place the anode and the cathode over the left and right dorsolateral prefrontal cortex areas, respectively (corresponding to F3 and F4 according to the EEG 10-20 system). We will use 5x5 cm electrodes and a 2mA current for 30 minutes per day. This montage is known as "bifrontal" setup and has been previously used in major depression trials
Other intervention name(s): TDCS
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: transcranial direct current stimulation; non invasive brain stimulation; bipolar disorder; depression