Escitalopram, Placebo and tDCS in Depression: a Non-inferiority Trial

• Status: Completed
• Trial end date: 2016-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Sao Paulo
• Collaborators: Brain & Behavior Research Foundation; Fundação de Amparo à Pesquisa do Estado de São Paulo
• Treatments: Citalopram; Dexetimide

Criteria

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).