Escitalopram, Placebo and tDCS in Depression: a Non-inferiority Trial (ELECT-TDCS)
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ClinicalTrials.gov Identifier: NCT01894815 |
Recruitment Status :
Completed
First Posted : July 10, 2013
Last Update Posted : December 5, 2016
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Condition or disease | Intervention/treatment | Phase |
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Major Depressive Disorder Major Depressive Disorder, Recurrent, Unspecified Major Depressive Disorder, Single Episode, Unspecified | Drug: Escitalopram oxalate Device: transcranial direct current stimulation Other: Sham tDCS + Placebo Pill | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 245 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Escitalopram and Transcranial Direct Current Stimulation in Major Depressive Disorder: a Double-blind, Placebo-controlled, Randomized, Non-inferiority Trial |
Study Start Date : | October 2013 |
Actual Primary Completion Date : | July 2016 |
Actual Study Completion Date : | November 2016 |

Arm | Intervention/treatment |
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Experimental: Active tDCS / placebo pill
transcranial direct current stimulation, using the parameters specified in Interventions.
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Device: transcranial direct current stimulation
The anode will be applied over the F3 area and the cathode over the F4 area. The current dose is 2mA, current density is 0.8 A/m2. Electrodes will be 5x5cm in size. The investigators will apply 15 daily, consecutive tDCS sessions (excluding weekends) and after that one session per week until the primary endpoint.
Other Name: tDCS - Soterix Medical Device for Clinical Trials |
Active Comparator: Sham tDCS / escitalopram
Escitalopram oxalate (Reconter), 10mg/day (first 3 weeks) and 20mg/day (week 3 to week 10).
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Drug: Escitalopram oxalate
The investigators will use 10mg and 20mg pills. The investigators will up-titrate escitalopram from 10 to 20mg/day according to the patient tolerability. The maximum dose (20mg/day) is sought to be achieved at week 3.
Other Name: Reconter |
Placebo Comparator: Sham tDCS / placebo pill
For sham tDCS, the device is automatically turned off after 30 second of stimulation and remains turned off during the 30-min session. For placebo pill, the pill has the same size, taste and color than escitalopram, and placebo and escitalopram will be provided in identical bottles, differing only according to a random-generated number placed in the label. |
Other: Sham tDCS + Placebo Pill
This group receives sham tDCS and placebo pill. |
- Changes in Hamilton Rating Scale for Depression, 17 items (HAMD17) [ Time Frame: Weeks 0 and 10 ]Continuous measure (score changes). Non-inferiority assessment: the difference between tDCS to escitalopram should be >50% of escitalopram to placebo efficacy.
- Change in HDRS [ Time Frame: Weeks 0, 3, 6, 8, 10 ]Continuous measure (score changes).
- Change in Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: Weeks 0, 3, 6, 10 ]Continuous measure (score changes).
- Change in Beck Depression Inventory (BDI) [ Time Frame: Weeks 0, 3, 6, 10 ]
- Change in Positive and Negative Affect Scale (PANAS) [ Time Frame: Weeks 0, 3, 6, 10 ]
- Change in State-Trait Anxiety Inventory (STAI) [ Time Frame: Weeks 0, 3, 6, 10 ]
- Hamilton Rating Scale for Depression, 17 items (HAMD17) [ Time Frame: Week 10 ]Response (≥50% improvement from week 0 to 10)
- Hamilton Rating Scale for Depression, 17 items (HAMD17) [ Time Frame: Week 10 ]Remission (HAMD17 ≤7) at week 10.
- Adverse events [ Time Frame: Week 3 and Week 10. ]Assessment and comparisons of tDCS and drug adverse events. We used a tDCS adverse events questionnaire (Brunoni et al., 2011) and the SAFTEE.
- Serious adverse events [ Time Frame: Up to Week 10. ]Serious adverse events include treatment-emergent hypomania/mania (YMRS>8), suicide, psychiatric hospitalization and others life-threatening or incapacitant events.
- Young Manic Rating Scale (YMRS) [ Time Frame: Week 3 and Week 10. ]Assessment of treatment-emergent hypomania/mania, defined as YRMS>8.
- Predictor of response [ Time Frame: Week 10 ]Age (years)
- Predictor of response [ Time Frame: Week 10 ]Gender
- Predictor of response [ Time Frame: Week 10 ]Low wage (less than 5 monthly wages in Brazil)
- Predictor of response [ Time Frame: Week 10 ]Recurrent depression
- Predictor of response [ Time Frame: Week 10 ]Chronic depression
- Predictor of response [ Time Frame: Week 10 ]Refractory depression
- Predictor of response [ Time Frame: Week 10 ]Severe depression
- Predictor of response [ Time Frame: Week 10 ]Benzodiazepine use
- Predictor of response [ Time Frame: Week 10 ]Higher education (>15 years of schooling)
- Predictor of response [ Time Frame: Week 10 ]Age of onset of the depressive episode (years)
- Predictor of response [ Time Frame: Week 10 ]Any anxiety disorder
- Predictor of response [ Time Frame: Week 10 ]Physical activity
- Predictor of response [ Time Frame: Week 10 ]melancholic depression
- Predictor of response [ Time Frame: Week 10 ]atypical depression
- Predictor of response [ Time Frame: Week 10 ]smoking status
- Predictor of response [ Time Frame: Week 10 ]hypertension
- Predictor of response [ Time Frame: Week 10 ]diabetes mellitus
- Predictor of response [ Time Frame: Week 10 ]ethnicity
- Predictor of response [ Time Frame: Week 10 ]marital status
- Predictor of response [ Time Frame: Week 10 ]employment status
- Predictor of response [ Time Frame: Week 10 ]obesity
- Predictor of response [ Time Frame: Week 10 ]familial psychiatry history
- Predictor of response [ Time Frame: Week 10 ]Temperament and Character Inventory - Novelty seeking
- Predictor of response [ Time Frame: Week 10 ]Any tDCS related adverse event.
- Predictor of response [ Time Frame: Week 10 ]Temperament and Character Inventory - Harm avoidance
- Predictor of response [ Time Frame: Week 10 ]Temperament and Character Inventory - Reward Dependence
- Predictor of response [ Time Frame: Week 10 ]Temperament and Character Inventory - Persistence
- Predictor of response [ Time Frame: Week 10 ]Temperament and Character Inventory - Cooperativeness
- Predictor of response [ Time Frame: Week 10 ]Temperament and Character Inventory - Self-transcendence
- Predictor of response [ Time Frame: Week 10 ]Temperament and Character Inventory - Self-directedness
- Predictor of response [ Time Frame: Week 10 ]FAS verbal fluency test
- Predictor of response [ Time Frame: Week 10 ]Digit span forward
- Predictor of response [ Time Frame: Week 10 ]Digit span backward
- Predictor of response [ Time Frame: Week 10 ]Trail Making Test - A
- Predictor of response [ Time Frame: Week 10 ]Trail Making Test - B
- Predictor of response [ Time Frame: Week 10 ]Symbol digit
- Predictor of response [ Time Frame: Week 10 ]Montreal Cognitive Assessment
- Predictor of response [ Time Frame: Week 3 and 10 ]Motor Cortical Excitability - Cortical silent period (left and right hemispheres)
- Predictor of response [ Time Frame: Week 3 and 10 ]Motor Cortical Excitability - Intracortical inhibition (left and right hemispheres)
- Predictor of response [ Time Frame: Week 3 and 10 ]Motor Cortical Excitability - Intracortical facilitation (left and right hemispheres)
- Predictor of response [ Time Frame: Week 3 and 10 ]Heart rate variability - HF
- Predictor of response [ Time Frame: Week 3 and 10 ]Heart rate variability - LF
- Predictor of response [ Time Frame: Week 3 and 10 ]Heart rate variability - RMSSD

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- HAMD17>=17
- more than 8 years of schooling OR able to read, speak and understand the Portuguese language.
- Low suicide risk.
Exclusion Criteria:
- Bipolar disorders.
- Schizophrenia and other psychotic disorders.
- Anxiety disorders, if it is the primary diagnosis (comorbidity with depression is not an exclusion disorder)
- Substance abuse or dependence.
- Depression symptoms better explained by medical conditions.
- Neurologic conditions (e.g., stroke, multiple sclerosis, brain tumor).
- Severe medical conditions.
- Pregnancy/breast-feeding.
- Severe suicidal ideation, suicidal planning or recent (<4 weeks) suicide attempt.
- Contra-indications to escitalopram.
- Current use of escitalopram in the current depressive episode.
- Use of escitalopram in a prior depressive episode that was not effective.
- Contra-indications to tDCS.
- Previous use of tDCS (current or previous depressive episode).

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): NCT01894815
Brazil | |
Institute of Psychiatry, HC-FMUSP | |
São Paulo, SP, Brazil | |
Hospital Universitário, Universidade de São Paulo | |
São Paulo, Brazil, 05508-000 |
Principal Investigator: | Andre R Brunoni, MD, PhD | University of Sao Paulo |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Andre Brunoni, MD, PhD, University of Sao Paulo |
ClinicalTrials.gov Identifier: | NCT01894815 |
Other Study ID Numbers: |
ELECT-TDCS FAPESP 2012/20911-5 ( Other Grant/Funding Number: FAPESP 2012/20911-5 ) |
First Posted: | July 10, 2013 Key Record Dates |
Last Update Posted: | December 5, 2016 |
Last Verified: | December 2016 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
major depressive disorder major depression depressive disorder major depressive episode |
Disease Depressive Disorder Depression Depressive Disorder, Major Pathologic Processes Mood Disorders Mental Disorders Behavioral Symptoms Dexetimide Citalopram Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action |
Neurotransmitter Agents Serotonin Agents Physiological Effects of Drugs Antidepressive Agents, Second-Generation Antidepressive Agents Psychotropic Drugs Antiparkinson Agents Anti-Dyskinesia Agents Parasympatholytics Autonomic Agents Peripheral Nervous System Agents Muscarinic Antagonists Cholinergic Antagonists Cholinergic Agents |