Transcranial Direct Current Stimulation (tDCS) as an Augmenting Intervention for Treatment-Resistant Major Depression: A Randomized, Double-Blind and Sham-Controlled Trial
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Major Depressive Disorder
- Sponsor
- Douglas Mental Health University Institute
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Quick Inventory for Depressive Symptomatology - Clinician (QIDS-C)
- Last Updated
- 10 years ago
Overview
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.
Investigators
MARCELO T. BERLIM
Director, Neuromodulation Research Clinic
Douglas Mental Health University Institute
Eligibility Criteria
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)
Outcomes
Primary Outcomes
Quick Inventory for Depressive Symptomatology - Clinician (QIDS-C)
Time Frame: 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 Outcomes
- 21-item Hamilton Depression Rating Scale (HAM-D21)(week 4)
- Quick Inventory of Depressive Symptomatology - Self-Report (QIDS-SR)(week 4)