Transcranial Direct Current Stimulation as an Augmenting Intervention for Major Depression

Major Depressive Disorder Clinical Trial

Official title:

Transcranial Direct Current Stimulation (tDCS) as an Augmenting Intervention for Treatment-Resistant Major Depression: A Randomized, Double-Blind and Sham-Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01450150
• Other study ID #: tDCS-ERB08/04-2011
• Status: Not yet recruiting
• Phase: Phase 2/Phase 3
• First received: October 9, 2011
• Last updated: January 19, 2016
• Start date: January 2016
• Est. completion date: October 2018

Study information

• Verified date: January 2016
• Source: Douglas Mental Health University Institute
• Contact: Marcelo T. Berlim, MD, MSc
• Phone: 514-761-6131
• Email: nrc.douglas[@]me.com
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: October 2018
• Est. primary completion date: October 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Device:
• Transcranial Direct Current Stimulation
20-minute daily sessions of 2 mA tDCS for 15 days (Monday to Friday on three consecutive weeks)
• Transcranial Direct Current Stimulation
The tDCS stimulator will be turned on for 30 seconds only, after which it will be gradually decreased and then turned off for the remainder of the 20-minute daily sessions for 15 days (Monday to Friday on three consecutive weeks).

Locations

Country	Name	City	State
Canada	Douglas Mental Health University Institute	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Douglas Mental Health University Institute

Country where clinical trial is conducted

Canada, 

References & Publications (4)

Arul-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. Review. — View Citation

Boggio 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. Epub 2007 Jun 11. — View Citation

Murphy 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. Review. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	21-item Hamilton Depression Rating Scale (HAM-D21)	Response to treatment is defined as a = 50% reduction in the scores of the HAM-D21. Remission is defined as a HAM-D21 score = 8	week 4	No
Secondary	Quick Inventory of Depressive Symptomatology - Self-Report (QIDS-SR)	Response is defined as a = 50% reduction in the scores of the QIDS-SR. Remission is defined as a QIDS-SR score = 5	week 4	No

External Links

•   Neuromodulation Program, Douglas Mental Health University Institute