Efficacy Study of Transcranial Direct Current Stimulation to Treat Major Depressive Disorder (SELECT-TDCS)
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ClinicalTrials.gov Identifier: NCT01033084 |
Recruitment Status
:
Completed
First Posted
: December 16, 2009
Last Update Posted
: December 6, 2011
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Depressive Disorder, Major | Device: transcranial direct current stimulation Drug: Sertraline Other: double placebo | Phase 2 Phase 3 |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 120 participants |
Allocation: | Randomized |
Intervention Model: | Factorial Assignment |
Masking: | Quadruple (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 |
Study Start Date : | December 2009 |
Actual Primary Completion Date : | December 2011 |
Actual Study Completion Date : | December 2011 |

Arm | Intervention/treatment |
---|---|
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.
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Drug: Sertraline
Patient will receive sertraline 50mg/day.
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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)
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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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- MADRS score [ Time Frame: repeated-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 ]

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

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): NCT01033084
Brazil | |
University of Sao Paulo | |
Sao Paulo, SP, Brazil, 01403-020 |
Principal Investigator: | Andre R Brunoni, MD | University of Sao Paulo |
Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 ) |
First Posted: | December 16, 2009 Key Record Dates |
Last Update Posted: | December 6, 2011 |
Last Verified: | December 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 |