NCT01894815 - Escitalopram, Placebo and tDCS in Depression: a Non-inferiority Trial | Biotech Hunter

Enrollment

245

Participants

Timeline

Start Date

October 31, 2013

Primary Completion Date

July 31, 2016

Study Completion Date

November 30, 2016

Conditions

Major Depressive DisorderMajor Depressive Disorder, Recurrent, UnspecifiedMajor Depressive Disorder, Single Episode, Unspecified

Interventions

DRUG

Escitalopram oxalate

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.

DEVICE

transcranial direct current stimulation

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.

OTHER

Sham tDCS + Placebo Pill

This group receives sham tDCS and placebo pill.

Trial Locations (2)

05508-000

Hospital Universitário, Universidade de São Paulo, São Paulo

Unknown

Institute of Psychiatry, HC-FMUSP, São Paulo