Efficacy Study of Transcranial Direct Current Stimulation to Treat Major Depressive Disorder

NCT01033084 | Completed Phase 2

• 2 other identifiers: USP-HU-001FAPESP2009/05728-7
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether transcranial direct current stimulation is an effective treatment for major depression, when compared (and combined) to sertraline and placebo.

Conditions

Depressive Disorder, Major

Keywords

Depressive Disorder, Major

Outcome Measures

Primary Outcomes (1)

• MADRS score

  repeated-measures

Secondary Outcomes (3)

• HDRS-17 score at week 6.

  week 6

• Remission rate (MADRS<=10)

  week 6

• MADRS score

  week 2

Study Arms (4)

Sham stimulation / sertraline

EXPERIMENTAL

In this arm, patients will receive sham stimulation and sertraline 50mg/day. In sham stimulation, the tDCS device is set in the same fashion as the active stimulation, but the device is turned off after one minute of stimulation.

Drug: Sertraline

Sham stimulation / placebo pill

SHAM COMPARATOR

Placebo pills are sugar pills having the same size and shape of the active pills. In sham stimulation, the tDCS device is set in the same fashion as the active stimulation, but the device is turned off after one minute of stimulation.

Other: double placebo

Active stimulation / Sertraline

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. Patients will receive Sertraline 50mg/day.

Device: transcranial direct current stimulation; Drug: Sertraline

Active stimulation / placebo pill

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. Placebo pills are sugar pills having the same size and shape of the active pill

Device: transcranial direct current stimulation

Interventions

transcranial direct current stimulation DEVICE

Transcranial direct current stimulation will be applied at 2mA, 30 minutes/day, for 10 weekdays consecutively and two extra stimulations at week 4 and 6.

Active stimulation / Sertraline; Active stimulation / placebo pill

Sertraline DRUG

Patient will receive sertraline 50mg/day.

Active stimulation / Sertraline; Sham stimulation / sertraline

double placebo OTHER

double placebo arm (sham stimulation/placebo pill)

Sham stimulation / placebo pill

Eligibility Criteria

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

You may qualify if:

• Depressive Disorder, Major (SCID)
• HDRS \> 18

You may not qualify if:

• Other axis I disorders, including Bipolar Disorder, Schizophrenia, Substance Abuse Disorders.
• Any axis II disorders.
• Any serious/life-threatening axis III disorders, such as Congestive Heart Failure, Pulmonary Obstructive Chronic Disease, Active Neoplasia.
• Neurological diseases such as Stroke (and Post-Stroke Depression), Dementias and others.

Sponsors & Collaborators

• University of Sao Paulo: lead
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator

Study Sites (1)

University of Sao Paulo

São Paulo, São Paulo, 01403-020, Brazil

Location

Related Publications (4)

• Brunoni AR, Valiengo L, Baccaro A, Zanao TA, de Oliveira JF, Vieira GP, Bueno VF, Goulart AC, Boggio PS, Lotufo PA, Bensenor IM, Fregni F. Sertraline vs. ELectrical Current Therapy for Treating Depression Clinical Trial--SELECT TDCS: design, rationale and objectives. Contemp Clin Trials. 2011 Jan;32(1):90-8. doi: 10.1016/j.cct.2010.09.007. Epub 2010 Sep 18.

  PMID: 20854930 BACKGROUND

• Alessandra Baccaro, Andre Russowsky Brunoni, Isabela Martins Bensenor, Felipe Fregni. Hypomanic episode in unipolar depression during transcranial direct current stimulation. Acta Neuropsychiatrica 22(6):316-318, 2010.

  BACKGROUND

• Brunoni AR, Kemp AH, Dantas EM, Goulart AC, Nunes MA, Boggio PS, Mill JG, Lotufo PA, Fregni F, Bensenor IM. Heart rate variability is a trait marker of major depressive disorder: evidence from the sertraline vs. electric current therapy to treat depression clinical study. Int J Neuropsychopharmacol. 2013 Oct;16(9):1937-49. doi: 10.1017/S1461145713000497. Epub 2013 Jun 12.

  PMID: 23759172 DERIVED

• Brunoni AR, Valiengo L, Baccaro A, Zanao TA, de Oliveira JF, Goulart A, Boggio PS, Lotufo PA, Bensenor IM, Fregni F. The sertraline vs. electrical current therapy for treating depression clinical study: results from a factorial, randomized, controlled trial. JAMA Psychiatry. 2013 Apr;70(4):383-91. doi: 10.1001/2013.jamapsychiatry.32.

  PMID: 23389323 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Transcranial Direct Current Stimulation; Sertraline

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques; 1-Naphthylamine; Amines; Organic Chemicals; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds

Study Officials

• Andre R Brunoni, MD

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: December 15, 2009
• First Posted: December 16, 2009
• Study Start: December 1, 2009
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: December 6, 2011

Record last verified: 2011-12

Locations

BR (1)