Investigating tDCS as a Treatment for Unipolar and Bipolar Depression

Study Overview
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Brief Summary
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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.

Official Title
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A Controlled Trial of Transcranial Direct Current Stimulation as a Treatment for Unipolar and Bipolar Depression

Conditions
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Unipolar Depression, Bipolar Depression

Intervention / Treatment
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* Device: Sham tDCS device
* Device: Soterix tDCS device


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active tDCS<br>Active tDCS | Device: Soterix tDCS device<br>* Active tDCS<br>|
| Sham Comparator: Sham tDCS<br>Sham tDCS | Device: Sham tDCS device<br>* Sham tDCS<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Montgomery Asberg Depression Rating Scale for Depression (MADRS) |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR) |  | 12 weeks | 
| Montreal Cognitive Assessment (MoCA): Global Cognitive Function |  | 8 weeks |