Follow-up Study of Transcranial Direct Current Stimulation to Treat Major Depressive Disorder

Major Depressive Disorder Clinical Trial

Official title:

An Open-label, Follow-up Study on Remitted Patients With Major Depressive Disorder Using Transcranial Direct Current Stimulation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01149213
• Other study ID #: USP-HU-003
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: June 22, 2010
• Last updated: March 24, 2012
• Start date: June 2010
• Est. completion date: March 2012

Study information

• Verified date: March 2012
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: March 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Device:
• transcranial 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.

Locations

Country	Name	City	State
Brazil	University of Sao Paulo	Sao Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relapse from depression	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	Week 4	Yes
Primary	Relapse from depression	Same as above.	Week 8	Yes
Primary	Relapse from depression	Same as above.	Week 12	Yes
Primary	Relapse from depression	Same as above.	Week 16	Yes
Primary	Relapse from depression	Same as above.	Week 20	Yes
Primary	Relapse from depression	Same as above.	Week 24	Yes