Transcranial Direct Current Stimulation as an Augmenting Intervention for Major Depression
1 other identifier
interventional
30
1 country
1
Brief Summary
Transcranial direct current stimulation (tDCS) is a noninvasive method to activate or de-activate neurons in superficial regions of the brain through the induction of weak electric currents in the brain tissue delivered by two scalp electrodes. Initial studies have shown tDCS to be effective for treating major depressive disorder (MDD), although there are negative trials in the specialized literature. One reason for these discrepant results might be that the duration of tDCS treatment in clinical trials to date (up to 2 weeks) is still insufficient to produce consistent clinical improvements. Thus, we intend to assess, in a sample of outpatients with MDD, whether a 3-week adjunctive course of active tDCS over the left dorsolateral prefrontal cortex is associated with a significant clinical improvement when compared to sham tDCS. The investigators hypothesize that subjects receiving active tDCS will present with significantly higher response and remission rates at weeks 3.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 major-depressive-disorder
Started Jan 2016
Typical duration for phase_2 major-depressive-disorder
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 9, 2011
CompletedFirst Posted
Study publicly available on registry
October 12, 2011
CompletedStudy Start
First participant enrolled
January 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2018
CompletedJanuary 20, 2016
January 1, 2016
2.8 years
October 9, 2011
January 19, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Quick Inventory for Depressive Symptomatology - Clinician (QIDS-C)
Response to treatment is defined as a ≥ 50% reduction in pretreatment symptoms severity at as measured by the mean QIDS-C score. Remission is defined as a QIDS-C score ≤ 5
week 4
Secondary Outcomes (2)
21-item Hamilton Depression Rating Scale (HAM-D21)
week 4
Quick Inventory of Depressive Symptomatology - Self-Report (QIDS-SR)
week 4
Study Arms (2)
Active tDCS
EXPERIMENTALSham tDCS
SHAM COMPARATORInterventions
20-minute daily sessions of 2 mA tDCS for 15 days (Monday to Friday on three consecutive weeks)
Eligibility Criteria
You may qualify if:
- Presence of a current major depressive disorder (according to the Diagnostic and Statistical Manual, Fourth Edition, Text Revision \[DSM-IV-TR\])
- Baseline score ≥ 13 on the QIDS-C
- Stable medication regimen (\> 4 weeks)
You may not qualify if:
- Psychotic features in the current episode
- Lifetime history of psychotic disorders and/or bipolar I or II disorders
- Substance or alcohol abuse/dependence in the past 6 months
- Lifetime history of a major neurological disease (e.g., Parkinson's, stroke)
- Uncontrolled medical disease (e.g., cardiovascular, renal)
- Pregnancy and/or lactation
- Presence of a specific contraindication for tDCS (e.g., personal history of epilepsy, metallic head implant, cardiac pacemaker)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Douglas Mental Health University Institute
Montreal, Quebec, H4H1R3, Canada
Related Publications (4)
Nitsche MA, Boggio PS, Fregni F, Pascual-Leone A. Treatment of depression with transcranial direct current stimulation (tDCS): a review. Exp Neurol. 2009 Sep;219(1):14-9. doi: 10.1016/j.expneurol.2009.03.038. Epub 2009 Apr 5.
PMID: 19348793BACKGROUNDMurphy DN, Boggio P, Fregni F. Transcranial direct current stimulation as a therapeutic tool for the treatment of major depression: insights from past and recent clinical studies. Curr Opin Psychiatry. 2009 May;22(3):306-11. doi: 10.1097/YCO.0b013e32832a133f.
PMID: 19339889BACKGROUNDArul-Anandam AP, Loo C. Transcranial direct current stimulation: a new tool for the treatment of depression? J Affect Disord. 2009 Oct;117(3):137-45. doi: 10.1016/j.jad.2009.01.016. Epub 2009 Feb 7.
PMID: 19201483BACKGROUNDBoggio PS, Rigonatti SP, Ribeiro RB, Myczkowski ML, Nitsche MA, Pascual-Leone A, Fregni F. A randomized, double-blind clinical trial on the efficacy of cortical direct current stimulation for the treatment of major depression. Int J Neuropsychopharmacol. 2008 Mar;11(2):249-54. doi: 10.1017/S1461145707007833. Epub 2007 Jun 11.
PMID: 17559710BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marcelo T. Berlim, MD, MSc
McGill University & Douglas Mental Health University Institute
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director, Neuromodulation Research Clinic
Study Record Dates
First Submitted
October 9, 2011
First Posted
October 12, 2011
Study Start
January 1, 2016
Primary Completion
October 1, 2018
Study Completion
October 1, 2018
Last Updated
January 20, 2016
Record last verified: 2016-01