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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Andre Brunoni, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01149213
First received: June 22, 2010
Last updated: March 24, 2012
Last verified: March 2012

June 22, 2010
March 24, 2012
June 2010
December 2011   (final data collection date for primary outcome measure)
  • Relapse from depression [ Time Frame: Week 4 ] [ Designated as safety issue: Yes ]

    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 [ Time Frame: Week 8 ] [ Designated as safety issue: Yes ]
    Same as above.
  • Relapse from depression [ Time Frame: Week 12 ] [ Designated as safety issue: Yes ]
    Same as above.
  • Relapse from depression [ Time Frame: Week 16 ] [ Designated as safety issue: Yes ]
    Same as above.
  • Relapse from depression [ Time Frame: Week 20 ] [ Designated as safety issue: Yes ]
    Same as above.
  • Relapse from depression [ Time Frame: Week 24 ] [ Designated as safety issue: Yes ]
    Same as above.
Relapse from depression [ Time Frame: Once a month ] [ Designated as safety issue: Yes ]

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
Complete list of historical versions of study NCT01149213 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Follow-up Study of Transcranial Direct Current Stimulation to Treat Major Depressive Disorder
An Open-label, Follow-up Study on Remitted Patients With Major Depressive Disorder Using Transcranial Direct Current Stimulation

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.

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.

Interventional
Phase 2
Phase 3
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Major Depressive Disorder
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.
Experimental: Transcranial Direct Current Stimulation

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: Device: transcranial direct current stimulation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
42
March 2012
December 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT01149213
USP-HU-003
No
Andre Brunoni, University of Sao Paulo
University of Sao Paulo
Not Provided
Principal Investigator: Andre R Brunoni, MD University of Sao Paulo
University of Sao Paulo
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP