Major Depressive Disorder
Conditions
Keywords
Major Depression, Transcranial Direct Current Stimulation, Randomized, Sham-Controlled Trial, tDCS
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.
Interventions
DEVICETranscranial Direct Current Stimulation
20-minute daily sessions of 2 mA tDCS for 15 days (Monday to Friday on three consecutive weeks)
Sponsors
Douglas Mental Health University Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Canada
Contacts
Primary ContactMarcelo T. Berlim, MD, MSc
Outcome results
None listed