Escitalopram, Placebo and tDCS in Depression: a Non-inferiority Trial
ELECT-TDCS
Escitalopram and Transcranial Direct Current Stimulation in Major Depressive Disorder: a Double-blind, Placebo-controlled, Randomized, Non-inferiority Trial
2 other identifiers
interventional
245
1 country
2
Brief Summary
Major depressive disorder (MDD) is a common psychiatric condition, mostly treated with antidepressant drugs, which are limited for issues such as refractoriness and adverse effects. In this context, the investigators investigate a non-pharmacological treatment known as transcranial direct current stimulation (tDCS). To prove that tDCS is similarly effective than antidepressants would have a tremendous impact in clinical psychiatry, since tDCS is virtually absent of adverse effects. Its ease of use, portability and low price are also interesting characteristics for using in primary and secondary health care. Thus, our aim is to compare tDCS against a fully dosed, effective antidepressant. The study will be a non-inferiority, randomized, double-blinded, placebo-controlled, three-arm trial comparing active tDCS/placebo pill, sham tDCS/escitalopram 20mg/day and sham tDCS/placebo pill. Our primary aim is to show that tDCS is not inferior to escitalopram 20mg/day with a noninferiority margin of at least 50% of the escitalopram-placebo effect.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 major-depressive-disorder
Started Oct 2013
Longer than P75 for phase_3 major-depressive-disorder
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 3, 2013
CompletedFirst Posted
Study publicly available on registry
July 10, 2013
CompletedStudy Start
First participant enrolled
October 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2016
CompletedDecember 5, 2016
December 1, 2016
2.8 years
July 3, 2013
December 1, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Changes in Hamilton Rating Scale for Depression, 17 items (HAMD17)
Continuous measure (score changes). Non-inferiority assessment: the difference between tDCS to escitalopram should be \>50% of escitalopram to placebo efficacy.
Weeks 0 and 10
Secondary Outcomes (53)
Change in HDRS
Weeks 0, 3, 6, 8, 10
Change in Montgomery-Asberg Depression Rating Scale (MADRS)
Weeks 0, 3, 6, 10
Change in Beck Depression Inventory (BDI)
Weeks 0, 3, 6, 10
Change in Positive and Negative Affect Scale (PANAS)
Weeks 0, 3, 6, 10
Change in State-Trait Anxiety Inventory (STAI)
Weeks 0, 3, 6, 10
- +48 more secondary outcomes
Study Arms (3)
Active tDCS / placebo pill
EXPERIMENTALtranscranial direct current stimulation, using the parameters specified in Interventions.
Sham tDCS / escitalopram
ACTIVE COMPARATOREscitalopram oxalate (Reconter), 10mg/day (first 3 weeks) and 20mg/day (week 3 to week 10).
Sham tDCS / placebo pill
PLACEBO COMPARATORFor 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.
Interventions
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.
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.
This group receives sham tDCS and placebo pill.
Eligibility Criteria
You may qualify if:
- HAMD17\>=17
- more than 8 years of schooling OR able to read, speak and understand the Portuguese language.
- Low suicide risk.
You may not qualify if:
- Bipolar disorders.
- Schizophrenia and other psychotic disorders.
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Sao Paulolead
- Fundação de Amparo à Pesquisa do Estado de São Paulocollaborator
- Brain & Behavior Research Foundationcollaborator
Study Sites (2)
Hospital Universitário, Universidade de São Paulo
São Paulo, São Paulo, 05508-000, Brazil
Institute of Psychiatry, HC-FMUSP
São Paulo, São Paulo, Brazil
Related Publications (4)
Goerigk SA, Padberg F, Chekroud A, Kambeitz J, Buhner M, Brunoni AR. Parsing the antidepressant effects of non-invasive brain stimulation and pharmacotherapy: A symptom clustering approach on ELECT-TDCS. Brain Stimul. 2021 Jul-Aug;14(4):906-912. doi: 10.1016/j.brs.2021.05.008. Epub 2021 May 26.
PMID: 34048940DERIVEDBulubas L, Padberg F, Bueno PV, Duran F, Busatto G, Amaro E Jr, Bensenor IM, Lotufo PA, Goerigk S, Gattaz W, Keeser D, Brunoni AR. Antidepressant effects of tDCS are associated with prefrontal gray matter volumes at baseline: Evidence from the ELECT-TDCS trial. Brain Stimul. 2019 Sep-Oct;12(5):1197-1204. doi: 10.1016/j.brs.2019.05.006. Epub 2019 May 8.
PMID: 31105027DERIVEDBrunoni AR, Moffa AH, Sampaio-Junior B, Borrione L, Moreno ML, Fernandes RA, Veronezi BP, Nogueira BS, Aparicio LVM, Razza LB, Chamorro R, Tort LC, Fraguas R, Lotufo PA, Gattaz WF, Fregni F, Bensenor IM; ELECT-TDCS Investigators. Trial of Electrical Direct-Current Therapy versus Escitalopram for Depression. N Engl J Med. 2017 Jun 29;376(26):2523-2533. doi: 10.1056/NEJMoa1612999.
PMID: 28657871DERIVEDBrunoni AR, Sampaio-Junior B, Moffa AH, Borrione L, Nogueira BS, Aparicio LV, Veronezi B, Moreno M, Fernandes RA, Tavares D, Bueno PV, Seibt O, Bikson M, Fraguas R, Bensenor IM. The Escitalopram versus Electric Current Therapy for Treating Depression Clinical Study (ELECT-TDCS): rationale and study design of a non-inferiority, triple-arm, placebo-controlled clinical trial. Sao Paulo Med J. 2015 May-Jun;133(3):252-63. doi: 10.1590/1516-3180.2014.00351712. Epub 2015 Jun 1.
PMID: 26176930DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Andre R Brunoni, MD, PhD
University of Sao Paulo
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD
Study Record Dates
First Submitted
July 3, 2013
First Posted
July 10, 2013
Study Start
October 1, 2013
Primary Completion
July 1, 2016
Study Completion
November 1, 2016
Last Updated
December 5, 2016
Record last verified: 2016-12
Data Sharing
- IPD Sharing
- Will not share