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

NCT01149213 | Completed Phase 2

• 1 other identifier: USP-HU-003
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depressive Disorder

Keywords

Major depressive disorder; follow-up; relapse; remission; transcranial direct current stimulation

Outcome Measures

Primary Outcomes (6)

• 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

• Relapse from depression

  Same as above.

  Week 8

• Relapse from depression

  Same as above.

  Week 12

• Relapse from depression

  Same as above.

  Week 16

• Relapse from depression

  Same as above.

  Week 20

• Relapse from depression

  Same as above.

  Week 24

Study Arms (1)

Transcranial Direct Current Stimulation

EXPERIMENTAL

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

Interventions

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.

Transcranial Direct Current Stimulation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

University of Sao Paulo

São Paulo, São Paulo, Brazil

Location

MeSH Terms

Conditions

Depressive Disorder, Major; Recurrence

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Andre R Brunoni, MD

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: June 22, 2010
• First Posted: June 23, 2010
• Study Start: June 1, 2010
• Primary Completion: December 1, 2011
• Study Completion: March 1, 2012
• Last Updated: March 27, 2012

Record last verified: 2012-03

Locations

BR (1)