Efficacy Study of Transcranial Direct Current Stimulation to Treat Major Depressive Disorder (SELECT-TDCS)
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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 Endpoint Classification: Efficacy Study Intervention Model: Factorial Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Factorial, Double-blinded, Randomized Clinical Trial on Major Depressive Disorder Using Transcranial Direct Current Stimulation |
- MADRS score [ Time Frame: repeated-measures ] [ Designated as safety issue: No ]
- HDRS-17 score at week 6. [ Time Frame: week 6 ] [ Designated as safety issue: No ]
- Remission rate (MADRS<=10) [ Time Frame: week 6 ] [ Designated as safety issue: No ]
- MADRS score [ Time Frame: week 2 ] [ Designated as safety issue: No ]
| 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.
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| 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.
Contacts and Locations| Brazil | |
| University of Sao Paulo | |
| Sao Paulo, SP, Brazil, 01403-020 | |
| Principal Investigator: | Andre R Brunoni, MD | University of Sao Paulo |
More Information
Additional Information:
Publications:
Additional 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 |
| Study First Received: | December 15, 2009 |
| Last Updated: | December 2, 2011 |
| Health Authority: | Brazil: National Committee of Ethics in Research |
Keywords provided by University of Sao Paulo:
|
Depressive Disorder, Major |
Additional relevant MeSH terms:
|
Depressive Disorder Depression Depressive Disorder, Major Mood Disorders Mental Disorders Behavioral Symptoms Sertraline Antidepressive Agents Psychotropic Drugs |
Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Serotonin Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 22, 2013