Major Depressive Disorder
Conditions
Keywords
Major depressive disorder, follow-up, relapse, remission, transcranial direct current stimulation
Brief summary
The investigators purpose is to follow remitted patients from their previous study using transcranial direct current stimulation (tDCS); as to verify whether this treatment prevents relapse.
Detailed description
Our first ongoing study (Efficacy Study of Transcranial Direct Current Stimulation (tDCS) to Treat Major Depressive Disorder) addresses whether tDCS is an effective treatment for depression treatment. The purpose of the present study is to determine whether tDCS is also an effective strategy for sustaining remission. We will enroll patients who presented remission using tDCS from our previous study and offer them to tDCS every other week for three months, than once a month for another three months. We will address whether tDCS prevents relapse by assessing depression scores once a month, using a time-to-event analysis. The importance of the present study is to determine whether tDCS is able to sustain remission during long-term follow-up of depressed patients.
Interventions
DEVICEtranscranial direct current stimulation
tDCS will be applied at 2mA/30 minutes, every other week during the first three months than once a month during the next three months.
Sponsors
University of Sao Paulo
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Patients from previous studies (ID:USP-HU-001 and ID:USP-HU-002) who: * received tDCS and responded. * received tDCS + sertraline and responded. * received sertraline or placebo and did not respond, and thereafter received tDCS during the cross-over phase and responded.
Exclusion criteria
Patients from previous studies who: * received tDCS and did not respond. * received tDCS + sertraline and did not respond. * received sertraline or placebo and responded. * did not respond during the crossover phase. * do not wish to participate in the present study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Relapse from depression | Week 4 | Once a month, we will address whether the patient has relapsed. Relapse criteria: * 2 consecutive MADRS scores \> 12 or * any MADRS scores \> 15 or * suicidal attempt or * severe suicidal ideation or * psychiatric hospitalization |
Countries
Brazil
Outcome results
None listed