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MAjor Depressive DisorderNCT01877447

Comparison of Two tDCS Protocols for the Treatment of Major Depressive Disorder

A study testing Transcranial Direct Current Stimulation in people with MAjor Depressive Disorder, run by University of Sao Paulo at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Transcranial direct cranial stimulation (tDCS) is a novel technique based on the application of a weak electrical current over the scalp through two electrodes - the anode, which facilitates neuronal depolarization, and the cathode, which leads to neuronal hyper-polarization. Read more about this study

Who is it for?
Ages 18 to 89 years
Conditions the study is for
MAjor Depressive Disorder
What is being tested?
Transcranial Direct Current Stimulation
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteBrazil
Study dates
Jul 2013to Nov 2013
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 89 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • patients with age between 18-89 years, depression diagnosis according to Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-iV); HAMD scores higher than 16; accordance to inform consent

Who cannot join

  • active neurologic or severe disorder (such as cancer or auto-imune)
  • pregnancy;
  • need for hospitalization

Trial locations and contacts

1 site in 1 country.

Brazil1 site

  • Hospital Universitário - USP

    São Paulo, São Paulo, 05508000

Other trials in Brazil

About this study

Official title: Comparison of Two Transcranial Direct Current Stimulation (tDCS) Protocols for the Treatment of Major Depressive Disorder: a Randomized, Double-blinded, Controlled Clinical Trial.

Transcranial direct cranial stimulation (tDCS) is a novel technique based on the application of a weak electrical current over the scalp through two electrodes - the anode, which facilitates neuronal depolarization, and the cathode, which leads to neuronal hyper-polarization. Recently, several open-label and sham-controlled clinical trials applied daily tDCS sessions for the treatment of major depressive disorder (MDD). Theoretically, tDCS displays depression improvement through anodal stimulation over the left dorsolateral prefrontal, inducing excitability-enhancing effects over this area, which is hypoactive during the acute depressive episode. The present study is aimed at comparing two different tDCS protocols: (1) active anodic stimulation over left dorsolateral prefrontal cortex with cathode placed over an extra cephalic area; (2) active cathode placed over the right dorsolateral prefrontal cortex with anode placed over an extra cephalic area.

Read the detailed description

The present research protocol will evaluate clinical effects of two different tDCS protocols: (1) active anodic stimulation over left dorsolateral prefrontal cortex with cathode placed over an extra cephalic area; (2) active cathode placed over the right dorsolateral prefrontal cortex with anode placed over an extra cephalic area. Patients will be clinically evaluated with the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) criteria for depression. Symptoms intensity will be rated according to The Hamilton Depression Scale (HAMD -17 items) - main outcome. Patients with scores higher than 16 will be included. Patients with active neurological or severe disorders (such as cancer or auto-imune disorders) will be excluded. The present study is a double-blinded, controlled, randomized trial with 30 patients with depression. The intervention protocol consist in 15 consecutive daily tDCS sessions (skipping the weekend). After meeting eligibility criteria, patients will be randomized (computer generated list) to one of the two intervention groups. We will use a direct current of 2.0 milliamperes (mA) for 30 min. The 35 cm2-rubber electrodes will be wrapped in cotton material, which should be moistened with saline as to reduce impedance. Patients will be clinically assessed at baseline and at end of 6 weeks. Main outcome will be based on HAMD-17 items at a final endpoint of 6-weeks, with secondary outcomes assessing Beck Depression Inventory (21 items) at 6 weeks. Other evaluation scales include Beck Anxiety Inventory, Hamilton Anxiety Scale and Safety and cognitive assessment will be performed with The Montreal Cognitive Assessment, adverse effects scales and clinical evaluation with a trained physician.

Keywords
tDCS, Brain stimulation, depressive disorder
Medical subject headings
Depressive Disorder, Major, Depressive Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Transcranial Direct Current StimulationDevice

    Also called tDCS, Brain polarization, Brain stimulation

    Current Stimulation with cathodal stimulation over right dorsolateral prefrontal cortex. Anodal stimulation over left deltoid region

Study groups in NCT01877447
Study groupRoleWhat they receive
cathodal F4ExperimentalTranscranial Direct Current Stimulation Cathodal tDCS over F4 (right dorsolateral prefrontal cortex) Anodal tDCS over the left deltoid (extra-cephalic) n=15
Receives: Device: Transcranial Direct Current Stimulation
Anodal F3ExperimentalTranscranial Direct Current Stimulation' Anodal tDCS over F3 (right dorsolateral prefrontal cortex) Cathodal tDCS over the right deltoid (extra-cephalic) n=15
Receives: Device: Transcranial Direct Current Stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Hamilton Rating Scale for Depression, 17 items (HAMD17)

    reduction of depressive symptoms as assessed by HAMD17

    Measured: Weeks 0, 3 and 6

Secondary outcomes (5)

  1. Montgomery-Asberg Depression Rating Scale (MADRS)

    reduction of depressive symptoms as assessed by MADRS

    Measured: Weeks 0, 3 and 6

  2. Beck Depression Inventory (BDI)

    reduction of depressive symptoms as assessed by BDI

    Measured: Weeks 0, 3 and 6

  3. Beck Anxiety Inventory (BAI)

    reduction of anxiety symptoms as assessed by BAI

    Measured: Weeks 0, 3 and 6

  4. Hamilton Anxiety Inventory (HAI)

    reduction of anxiety symptoms as assessed by HAI

    Measured: Weeks 0, 3 and 6

  5. The Montreal Cognitive Assessment (Moca)

    evaluate cognitive stability as assessed by Moca

    Measured: Weeks 0 and 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jun 2013 (estimated)
  2. Study startJul 2013
  3. Primary completionOct 2013
  4. Study completionNov 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01877447
Sponsor's protocol ID
aF3_cF4_F32
Status last verified
Dec 2013
First submitted
24 May 2013
Last updated
16 Dec 2013
Results posted
No
Data monitoring committee
Yes

Publications

  • Brunoni AR, Kemp AH, Shiozawa P, Cordeiro Q, Valiengo LC, Goulart AC, Coprerski B, Lotufo PA, Brunoni D, Perez AB, Fregni F, Bensenor IM. Impact of 5-HTTLPR and BDNF polymorphisms on response to sertraline versus transcranial direct current stimulation: implications for the serotonergic system. Eur Neuropsychopharmacol. 2013 Nov;23(11):1530-40. doi: 10.1016/j.euroneuro.2013.03.009. Epub 2013 Apr 21.

    PubMed 23615118

  • Brunoni AR, Benute GR, Fraguas R, Santos NO, Francisco RP, de Lucia MC, Zugaib M. The self-rated Inventory of Depressive Symptomatology for screening prenatal depression. Int J Gynaecol Obstet. 2013 Jun;121(3):243-6. doi: 10.1016/j.ijgo.2013.01.011. Epub 2013 Mar 15.

    PubMed 23499135

  • Kalu UG, Sexton CE, Loo CK, Ebmeier KP. Transcranial direct current stimulation in the treatment of major depression: a meta-analysis. Psychol Med. 2012 Sep;42(9):1791-800. doi: 10.1017/S0033291711003059. Epub 2012 Jan 12.

    PubMed 22236735

  • Brunoni AR, Valiengo L, Baccaro A, Zanao TA, de Oliveira JF, Goulart A, Boggio PS, Lotufo PA, Bensenor IM, Fregni F. The sertraline vs. electrical current therapy for treating depression clinical study: results from a factorial, randomized, controlled trial. JAMA Psychiatry. 2013 Apr;70(4):383-91. doi: 10.1001/2013.jamapsychiatry.32.

    PubMed 23389323

  • Brunoni AR, Ferrucci R, Fregni F, Boggio PS, Priori A. Transcranial direct current stimulation for the treatment of major depressive disorder: a summary of preclinical, clinical and translational findings. Prog Neuropsychopharmacol Biol Psychiatry. 2012 Oct 1;39(1):9-16. doi: 10.1016/j.pnpbp.2012.05.016. Epub 2012 May 28.

    PubMed 22651961

  • Brunoni AR, Ferrucci R, Bortolomasi M, Vergari M, Tadini L, Boggio PS, Giacopuzzi M, Barbieri S, Priori A. Transcranial direct current stimulation (tDCS) in unipolar vs. bipolar depressive disorder. Prog Neuropsychopharmacol Biol Psychiatry. 2011 Jan 15;35(1):96-101. doi: 10.1016/j.pnpbp.2010.09.010. Epub 2010 Sep 18.

    PubMed 20854868

Questions about this trial

What is this clinical trial studying?

A study testing Transcranial Direct Current Stimulation in people with MAjor Depressive Disorder, run by University of Sao Paulo at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hamilton Rating Scale for Depression, 17 items (HAMD17) (time frame: Weeks 0, 3 and 6). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01877447, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2013.

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