Status:
COMPLETED
Escitalopram, Placebo and tDCS in Depression: a Non-inferiority Trial
Lead Sponsor:
University of Sao Paulo
Collaborating Sponsors:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Brain & Behavior Research Foundation
Conditions:
Major Depressive Disorder
Major Depressive Disorder, Recurrent, Unspecified
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
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, t...
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, t...
Eligibility Criteria
Inclusion
- HAMD17\>=17
- more than 8 years of schooling OR able to read, speak and understand the Portuguese language.
- Low suicide risk.
Exclusion
- 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).
Key Trial Info
Start Date :
October 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2016
Estimated Enrollment :
245 Patients enrolled
Trial Details
Trial ID
NCT01894815
Start Date
October 1 2013
End Date
November 1 2016
Last Update
December 5 2016
Active Locations (2)
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1
Hospital Universitário, Universidade de São Paulo
São Paulo, São Paulo, Brazil, 05508-000
2
Institute of Psychiatry, HC-FMUSP
São Paulo, São Paulo, Brazil