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Completed

NCT Number: NCT01149213

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

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.

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Key information

Conditions

Major Depressive Disorder Depressive Disorder Depressive Disorder, Major Disease Attributes Mental Disorders Mood Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

University of Sao Paulo

São Paulo, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Transcranial Direct Current Stimulation

Device

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 outcomes

  1. Relapse from depression

    Time frame: 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

  2. Relapse from depression

    Time frame: Week 8

    Same as above.

  3. Relapse from depression

    Time frame: Week 12

    Same as above.

  4. Relapse from depression

    Time frame: Week 16

    Same as above.

  5. Relapse from depression

    Time frame: Week 20

    Same as above.

  6. Relapse from depression

    Time frame: Week 24

    Same as above.

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2012
First posted
Jun 23, 2010
Registry last updated
Mar 27, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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