Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Transcranial Direct Current Stimulation for the Treatment of Bipolar Depression (TDCS-BD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02152878
Recruitment Status : Completed
First Posted : June 2, 2014
Last Update Posted : November 22, 2016
Sponsor:
Collaborator:
Brain & Behavior Research Foundation
Information provided by (Responsible Party):
Andre Brunoni, University of Sao Paulo

Tracking Information
First Submitted Date  ICMJE May 29, 2014
First Posted Date  ICMJE June 2, 2014
Last Update Posted Date November 22, 2016
Study Start Date  ICMJE April 2014
Actual Primary Completion Date July 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 30, 2014)
Change in Hamilton Scale for Depression, 17 items [ Time Frame: week 0 (baseline), week 2, week 4 and week 6 (endpoint) ]
Continuous measure (score change)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 30, 2014)
Change in Montgomery-Asberg Depression Rating Scale [ Time Frame: week 0 (baseline), week 2, week 4 and week 6 (endpoint) ]
Continuous measure (score changes)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Transcranial Direct Current Stimulation for the Treatment of Bipolar Depression
Official Title  ICMJE Transcranial Direct Current Stimulation for the Treatment of Bipolar Depression
Brief 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Depression, Bipolar
Intervention  ICMJE
  • Device: Sham stimulation
    For sham tDCS, the device will be turned off after 30 seconds of stimulation.
    Other Name: TDCS
  • Device: Active 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
Study Arms  ICMJE
  • Active Comparator: Active stimulation
    Active stimulation (tDCS) will be used in the dose of 2mA /30 min per day, for 10 days and two extra sessions every other week (total of 12 sessions).
    Intervention: Device: Active stimulation
  • Placebo Comparator: Sham stimulation
    For Sham Transcranial Direct Current Stimulation, the device is automatically turned off after 30 seconds of stimulation and remains turned off.
    Intervention: Device: Sham stimulation
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 30, 2014)
60
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2016
Actual Primary Completion Date July 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • bipolar depressed (type I, II or not otherwise specified) participants with symptoms in spite of an adequate treatment course with mood stabilizers.
  • the depressive episode has to be of at least moderate intensity (baseline HDRS>=16)
  • read and understand Portuguese

Exclusion Criteria:

  • other neuropsychiatric conditions, such as schizophrenia, substance dependence, dementias, traumatic brain injury, epilepsy and so forth (although participants with anxiety disorders can be included whether the primary diagnosis is BDD);
  • mixed states, defined as simultaneously presenting (hypo)manic symptoms with a Young Manic Rating Scale (YMRS) > 8;
  • pregnancy;
  • specific contra-indications to tDCS;
  • severe/life-threatening clinical conditions. Participants will have to be drug-free or at stable drug regimen for at least 6 weeks prior to trial onset. Benzodiazepine drugs will be allowed, although only at low doses (less than 20mg/day of diazepam or equivalent).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02152878
Other Study ID Numbers  ICMJE BETTER
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Andre Brunoni, University of Sao Paulo
Study Sponsor  ICMJE University of Sao Paulo
Collaborators  ICMJE Brain & Behavior Research Foundation
Investigators  ICMJE
Principal Investigator: Andre R Brunoni, MD, PhD University of São Paulo
PRS Account University of Sao Paulo
Verification Date November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP