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
  Purpose

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.


Condition Intervention Phase
Major Depressive Disorder
Device: transcranial direct current stimulation
Phase 2
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-label, Follow-up Study on Remitted Patients With Major Depressive Disorder Using Transcranial Direct Current Stimulation

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • 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.


Enrollment: 42
Study Start Date: June 2010
Study Completion Date: March 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01149213

Locations
Brazil
University of Sao Paulo
Sao Paulo, SP, Brazil
Sponsors and Collaborators
University of Sao Paulo
Investigators
Principal Investigator: Andre R Brunoni, MD University of Sao Paulo
  More Information

No publications provided

Responsible Party: Andre Brunoni, MD, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01149213     History of Changes
Other Study ID Numbers: USP-HU-003
Study First Received: June 22, 2010
Last Updated: March 24, 2012
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by University of Sao Paulo:
Major depressive disorder
follow-up
relapse
remission
transcranial direct current stimulation

Additional relevant MeSH terms:
Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms

ClinicalTrials.gov processed this record on July 29, 2014