Transcranial Direct Current Stimulation as an Augmenting Intervention for Major Depression

Phase 2

• Conditions: Major Depressive Disorder
• Interventions: Device: Transcranial Direct Current Stimulation

• Registration Number: NCT01450150
• Lead Sponsor: Douglas Mental Health University Institute

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-10-09
• Study First Submitted QC: 2011-10-11
• Study First Posted: 2011-10-12
• Status Verified: 2016-01
• Study Start: 2016-01
• Last Update Submitted: 2016-01-19
• Last Update Posted: 2016-01-20
• Primary Completion: 2018-10
• Study Completion: 2018-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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)

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active tDCS	Transcranial Direct Current Stimulation	-
Sham tDCS	Transcranial Direct Current Stimulation	-

Primary Outcome Measures

Name	Time	Method
Quick Inventory for Depressive Symptomatology - Clinician (QIDS-C)	week 4	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

Secondary Outcome Measures

Name	Time	Method
21-item Hamilton Depression Rating Scale (HAM-D21)	week 4	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
Quick Inventory of Depressive Symptomatology - Self-Report (QIDS-SR)	week 4	Response is defined as a ≥ 50% reduction in the scores of the QIDS-SR. Remission is defined as a QIDS-SR score ≤ 5

Trial Locations

Locations (1)

Douglas Mental Health University Institute; 🇨🇦 Montreal, Quebec, Canada