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Major Depressive Disorder | Escitalopram, Placebo and tDCS in Depression: a Non-inferiority Trial

Major Depressive Disorder research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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).

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Major Depressive Disorder

Major Depressive Disorder, Recurrent, Unspecified

Major Depressive Disorder, Single Episode, Unspecified

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Escitalopram oxalateThe 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.

Device:transcranial direct current stimulationThe 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:Sham tDCS + Placebo PillThis group receives sham tDCS and placebo pill.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Active tDCS / placebo pilltranscranial direct current stimulation, using the parameters specified in Interventions.

Sham tDCS / escitalopramEscitalopram oxalate (Reconter), 10mg/day (first 3 weeks) and 20mg/day (week 3 to week 10).

Sham tDCS / placebo pillFor 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.

Study Status

Completed

Start Date: October 2013

Completed Date: November 2016

Phase: Phase 3

Type: Interventional

Design:

Primary Outcome: Changes in Hamilton Rating Scale for Depression, 17 items (HAMD17)

Secondary Outcome: Change in HDRS

Study sponsors, principal investigator, and references

Principal Investigator: Andre R Brunoni, MD, PhD

Lead Sponsor: University of Sao Paulo

Collaborator: Fundação de Amparo à Pesquisa do Estado de São Paulo

More information:https://clinicaltrials.gov/show/NCT01894815

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