Bipolar Depression, Unipolar Depression
Conditions
Brief summary
Transcranial direct current stimulation (tDCS) is a novel treatment approach for depression that has shown promising efficacy in four recent double-blind, randomized, sham-controlled trials (RCT) and a meta-analysis. This study is a RCT of tDCS in depressed patients, testing its efficacy in both unipolar and bipolar depression. Mood, cognitive test performance and biomarkers will be measured during the trial.
Interventions
DEVICESham tDCS device
Sham tDCS
DEVICESoterix tDCS device
Active tDCS
Sponsors
Duke University
Emory University
Sheppard Pratt Health System
University of Medicine and Dentistry of New Jersey
University of Texas
The University of New South Wales
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years of age or above. * Meets criteria for a DSM-IV Major Depressive Episode with duration of at least 4 weeks. * Total score ≥ 20 on the Montgomery-Asberg Depression Rating Scale at study entry.
Exclusion criteria
* Current episode duration greater than 3 years. * Failed more than 3 adequate antidepressant trials in current episode. * DSM-IV psychotic disorder. * Drug or alcohol abuse or dependence (preceding 3 months). * Inadequate response to ECT in the current episode of depression. * Rapid clinical response required, e.g., high suicide risk. * Significant acute suicide risk, defined as follows: suicide attempt within the previous 6 months that required medical treatment; or ≥ 2 suicide attempts in the past 12 months; or has a clear-cut plan for suicide and states that they cannot guarantee that they will call their regular psychiatrist or the investigator if the impulse to implement the plan becomes substantial during the study; or in the investigator's opinion, is likely to attempt suicide within the next 6 months. * Clinically defined neurological disorder or insult. * Metal in the cranium, skull defects, or skin lesions on scalp (cuts, abrasions, rash) at proposed electrode sites. * Pregnancy. * Concurrent long acting benzodiazepines, ritalin or dexamphetamine medication.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Montgomery Asberg Depression Rating Scale for Depression (MADRS) | 12 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR) | 12 weeks |
| Montreal Cognitive Assessment (MoCA): Global Cognitive Function | 8 weeks |
Countries
Australia, United States
Outcome results
None listed