Efficacy Study of Transcranial Direct Current Stimulation to Treat Major Depressive Disorder - Full Text View

Purpose

The purpose of this study is to determine whether transcranial direct current stimulation is an effective treatment for major depression, when compared (and combined) to sertraline and placebo.

Condition	Intervention	Phase
Depressive Disorder, Major	Device: transcranial direct current stimulation Drug: Sertraline Other: double placebo	Phase 2 Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Factorial Assignment Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Factorial, Double-blinded, Randomized Clinical Trial on Major Depressive Disorder Using Transcranial Direct Current Stimulation

Resource links provided by NLM:

Drug Information available for: Sertraline hydrochloride Sertraline

U.S. FDA Resources

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

Primary Outcome Measures:

MADRS score [ Time Frame: repeated-measures ]

Secondary Outcome Measures:

HDRS-17 score at week 6. [ Time Frame: week 6 ]
Remission rate (MADRS<=10) [ Time Frame: week 6 ]
MADRS score [ Time Frame: week 2 ]


Enrollment:	120
Study Start Date:	December 2009
Study Completion Date:	December 2011
Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Sham stimulation / sertraline In this arm, patients will receive sham stimulation and sertraline 50mg/day. In sham stimulation, the tDCS device is set in the same fashion as the active stimulation, but the device is turned off after one minute of stimulation.	Drug: Sertraline Patient will receive sertraline 50mg/day.
Sham Comparator: Sham stimulation / placebo pill Placebo pills are sugar pills having the same size and shape of the active pills. In sham stimulation, the tDCS device is set in the same fashion as the active stimulation, but the device is turned off after one minute of stimulation.	Other: double placebo double placebo arm (sham stimulation/placebo pill)
Experimental: Active stimulation / Sertraline In active stimulation, the anode is placed over the left dorsolateral prefrontal cortex and the cathode is placed over the right prefrontal cortex. They are located five centimeters ventrally of the primary motor area, which are located five centimeters laterally of the central point of the scalp (which is located on the intersection of the sagittal and median curves). The device will deliver a charge of 2mA for 30 minutes. Patients will receive Sertraline 50mg/day.	Device: transcranial direct current stimulation Transcranial direct current stimulation will be applied at 2mA, 30 minutes/day, for 10 weekdays consecutively and two extra stimulations at week 4 and 6. Drug: Sertraline Patient will receive sertraline 50mg/day.
Experimental: Active stimulation / placebo pill In active stimulation, the anode is placed over the left dorsolateral prefrontal cortex and the cathode is placed over the right prefrontal cortex. They are located five centimeters ventrally of the primary motor area, which are located five centimeters laterally of the central point of the scalp (which is located on the intersection of the sagittal and median curves). The device will deliver a charge of 2mA for 30 minutes. Placebo pills are sugar pills having the same size and shape of the active pill	Device: transcranial direct current stimulation Transcranial direct current stimulation will be applied at 2mA, 30 minutes/day, for 10 weekdays consecutively and two extra stimulations at week 4 and 6.

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Eligibility


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

Criteria

Inclusion Criteria:

Depressive Disorder, Major (SCID)
HDRS > 18

Exclusion Criteria:

Other axis I disorders, including Bipolar Disorder, Schizophrenia, Substance Abuse Disorders.
Any axis II disorders.
Any serious/life-threatening axis III disorders, such as Congestive Heart Failure, Pulmonary Obstructive Chronic Disease, Active Neoplasia.
Neurological diseases such as Stroke (and Post-Stroke Depression), Dementias and others.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01033084

Locations


Brazil
University of Sao Paulo
Sao Paulo, SP, Brazil, 01403-020

Sponsors and Collaborators

University of Sao Paulo

Fundação de Amparo à Pesquisa do Estado de São Paulo

Investigators


Principal Investigator:	Andre R Brunoni, MD	University of Sao Paulo

More Information

Additional Information:

Web Page of the study (In Portuguese) This link exits the ClinicalTrials.gov site

Publications:

Brunoni AR, Valiengo L, Baccaro A, Zanao TA, de Oliveira JF, Vieira GP, Bueno VF, Goulart AC, Boggio PS, Lotufo PA, Bensenor IM, Fregni F. Sertraline vs. ELectrical Current Therapy for Treating Depression Clinical Trial--SELECT TDCS: design, rationale and objectives. Contemp Clin Trials. 2011 Jan;32(1):90-8. doi: 10.1016/j.cct.2010.09.007. Epub 2010 Sep 18.

Alessandra Baccaro, Andre Russowsky Brunoni, Isabela Martins Bensenor, Felipe Fregni. Hypomanic episode in unipolar depression during transcranial direct current stimulation. Acta Neuropsychiatrica 22(6):316-318, 2010.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Brunoni AR, Kemp AH, Dantas EM, Goulart AC, Nunes MA, Boggio PS, Mill JG, Lotufo PA, Fregni F, Benseñor IM. Heart rate variability is a trait marker of major depressive disorder: evidence from the sertraline vs. electric current therapy to treat depression clinical study. Int J Neuropsychopharmacol. 2013 Oct;16(9):1937-49. doi: 10.1017/S1461145713000497. Epub 2013 Jun 12.

Brunoni AR, Valiengo L, Baccaro A, Zanão TA, de Oliveira JF, Goulart A, Boggio PS, Lotufo PA, Benseñor 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.


Responsible Party:	Andre Brunoni, MD, University of Sao Paulo
ClinicalTrials.gov Identifier:	NCT01033084 History of Changes
Other Study ID Numbers:	USP-HU-001 FAPESP2009/05728-7 ( Other Grant/Funding Number: FAPESP 2009/05728-7 )
Study First Received:	December 15, 2009
Last Updated:	December 2, 2011

Keywords provided by Andre Brunoni, University of Sao Paulo:


Depressive Disorder, Major

Additional relevant MeSH terms:


Disease Depressive Disorder Depression Depressive Disorder, Major Pathologic Processes Mood Disorders Mental Disorders Behavioral Symptoms Sertraline	Antidepressive Agents Psychotropic Drugs Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Neurotransmitter Agents Serotonin Agents Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 19, 2017

Efficacy Study of Transcranial Direct Current Stimulation to Treat Major Depressive Disorder (SELECT-TDCS)