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

Primary Purpose

Major Depressive Disorder

Status
Completed
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
transcranial direct current stimulation
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring Major depressive disorder, follow-up, relapse, remission, transcranial direct current stimulation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Sao Paulo

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Transcranial Direct Current Stimulation

Arm Description

In active stimulation, the anode is placed over the left dorsolateral prefrontal cortex and the cathode is placed over the right prefrontal cortex. They are located five centimeters ventrally of the primary motor area, which are located five centimeters laterally of the central point of the scalp (which is located on the intersection of the sagittal and median curves). The device will deliver a charge of 2mA for 30 minutes. The patient will receive tDCS every other week during the first three months, then once a month during the next three months.

Outcomes

Primary Outcome Measures

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
Relapse from depression
Same as above.
Relapse from depression
Same as above.
Relapse from depression
Same as above.
Relapse from depression
Same as above.
Relapse from depression
Same as above.

Secondary Outcome Measures

Full Information

First Posted
June 22, 2010
Last Updated
March 24, 2012
Sponsor
University of Sao Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT01149213
Brief Title
Follow-up Study of Transcranial Direct Current Stimulation to Treat Major Depressive Disorder
Official Title
An Open-label, Follow-up Study on Remitted Patients With Major Depressive Disorder Using Transcranial Direct Current Stimulation
Study Type
Interventional

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
March 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
Major depressive disorder, follow-up, relapse, remission, transcranial direct current stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Transcranial Direct Current Stimulation
Arm Type
Experimental
Arm Description
In active stimulation, the anode is placed over the left dorsolateral prefrontal cortex and the cathode is placed over the right prefrontal cortex. They are located five centimeters ventrally of the primary motor area, which are located five centimeters laterally of the central point of the scalp (which is located on the intersection of the sagittal and median curves). The device will deliver a charge of 2mA for 30 minutes. The patient will receive tDCS every other week during the first three months, then once a month during the next three months.
Intervention Type
Device
Intervention Name(s)
transcranial direct current stimulation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Relapse from depression
Description
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
Time Frame
Week 4
Title
Relapse from depression
Description
Same as above.
Time Frame
Week 8
Title
Relapse from depression
Description
Same as above.
Time Frame
Week 12
Title
Relapse from depression
Description
Same as above.
Time Frame
Week 16
Title
Relapse from depression
Description
Same as above.
Time Frame
Week 20
Title
Relapse from depression
Description
Same as above.
Time Frame
Week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andre R Brunoni, MD
Organizational Affiliation
University of Sao Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Sao Paulo
City
Sao Paulo
State/Province
SP
Country
Brazil

12. IPD Sharing Statement

Learn more about this trial

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

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