Transcranial Direct Current Stimulation as an Augmenting Intervention for Major Depression

Douglas Mental Health University Institute30 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Major Depressive Disorder

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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)

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

Time frame: week 4

Secondary Outcomes

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

Time frame: week 4

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

Time frame: week 4

Transcranial Direct Current Stimulation as an Augmenting Intervention for Major Depression

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts