Escitalopram, Placebo and tDCS in Depression: a Non-inferiority Trial
Information source: University of Sao Paulo
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Major Depressive Disorder; Major Depressive Disorder, Recurrent, Unspecified; Major Depressive Disorder, Single Episode, Unspecified
Intervention: Escitalopram oxalate (Drug); transcranial direct current stimulation (Device)
Phase: Phase 3
Status: Recruiting
Sponsored by: University of Sao Paulo Official(s) and/or principal investigator(s): Andre R Brunoni, MD, PhD, Principal Investigator, Affiliation: University of Sao Paulo
Overall contact: Andre R Brunoni, MD, PhD, Email: brunowsky@gmail.com
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.
Clinical Details
Official title: Escitalopram and Transcranial Direct Current Stimulation in Major Depressive Disorder: a Double-blind, Placebo-controlled, Randomized, Non-inferiority Trial
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Change in Hamilton Rating Scale for Depression, 17 items (HAMD17)
Secondary outcome: Change in Montgomery-Asberg Depression Rating Scale (MADRS)Change in Beck Depression Inventory (BDI) Hamilton Rating Scale for Depression, 17 items (HAMD17) Hamilton Rating Scale for Depression, 17 items (HAMD17)
Detailed description:
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 researchers investigate a non-pharmacological treatment known
as transcranial direct current stimulation (tDCS). In a prior clinical trial with 120
patients with MDD, the investigators demonstrated that the combination of tDCS with
sertraline 50mg/day had increased, faster effects on depressive symptoms (Brunoni et al.,
JAMA Psychiatry, 2013). However, although the investigators suggested that tDCS vs.
sertraline had similar efficacy, such comparison was compromised due to the low sertraline
dose and also because the comparison of sertraline vs. placebo was not significant. 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 for ten weeks, randomizing 240
patients with MDD in a 3: 3:2 ratio (less to placebo). 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. As secondary aims, the researchers will investigate putative
biomarkers for tDCS response. This is important considering the large sample size of this
study and also the paucity of tDCS studies - therefore, the identification of such
biomarkers could generate new hypothesis for future studies and for tDCS' mechanisms of
action. The biomarkers will be: genetic polymorphisms (BDNF, SLC6A4, THP1, 5HT2A); serum
markers (BDNF); motor cortical excitability (cortical silent period, intracortical
inhibition, intracortical facilitation); heart rate variability; and neuroimaging
(structural volume of the dorsolateral prefrontal and anterior cingulate cortex, white
matter tracts of the prefrontal cortex and posterior cingulate cortex connectivity). This
project represents a novel research line in our Institution, and the investigators thereby
propose the onset of a new center denominated C. I.N. A. (Interdisciplinary Center for Applied
Neuromodulation) that will foment the use and development of projects using neuromodulation
techniques. This new center will also interact with other centers on the fields of clinical
research, neurosciences and neuropsychiatry.
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- HAMD17>=17
- more than 8 years of schooling OR able to read, speak and understand the Portuguese
language.
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).
Locations and Contacts
Andre R Brunoni, MD, PhD, Email: brunowsky@gmail.com
Hospital Universitário, Universidade de São Paulo, São Paulo 05508-000, Brazil; Recruiting Cibele Soares, MS, Email: pesquisacientificahu@gmail.com Andre R Brunoni, MD, PhD, Principal Investigator
Institute of Psychiatry, HC-FMUSP, São Paulo, SP, Brazil; Active, not recruiting
Additional Information
Trial information for participants and investigators. Trial information for participants and investigators.
Starting date: October 2013
Last updated: May 26, 2015
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