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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02152878
First Posted: June 2, 2014
Last Update Posted: November 22, 2016
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.
Collaborator:
Brain & Behavior Research Foundation
Information provided by (Responsible Party):
Andre Brunoni, University of Sao Paulo
  Purpose
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.

Condition Intervention Phase
Depression, Bipolar Device: Sham stimulation Device: Active stimulation Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Transcranial Direct Current Stimulation for the Treatment of Bipolar Depression

Resource links provided by NLM:


Further study details as provided by Andre Brunoni, University of Sao Paulo:

Primary Outcome Measures:
  • 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)


Secondary Outcome Measures:
  • Change in Montgomery-Asberg Depression Rating Scale [ Time Frame: week 0 (baseline), week 2, week 4 and week 6 (endpoint) ]
    Continuous measure (score changes)


Enrollment: 60
Study Start Date: April 2014
Study Completion Date: November 2016
Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).
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
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.
Device: Sham stimulation
For sham tDCS, the device will be turned off after 30 seconds of stimulation.
Other Name: TDCS

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.
  Eligibility

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02152878


Locations
Brazil
University Hospital
São Paulo, Brazil, 05508000
Sponsors and Collaborators
University of Sao Paulo
Brain & Behavior Research Foundation
Investigators
Principal Investigator: Andre R Brunoni, MD, PhD University of São Paulo
  More Information

Additional Information:
Responsible Party: Andre Brunoni, MD, PhD, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT02152878     History of Changes
Other Study ID Numbers: BETTER
First Submitted: May 29, 2014
First Posted: June 2, 2014
Last Update Posted: November 22, 2016
Last Verified: November 2016

Keywords provided by Andre Brunoni, University of Sao Paulo:
transcranial direct current stimulation
non invasive brain stimulation
bipolar disorder
depression

Additional relevant MeSH terms:
Depression
Depressive Disorder
Bipolar Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Bipolar and Related Disorders