Investigating tDCS as a Treatment for Unipolar and Bipolar Depression

Phase 2

Completed

• Conditions: Unipolar Depression; Bipolar Depression
• Interventions: Device: Soterix tDCS device; Device: Sham tDCS device

• Registration Number: NCT01562184
• Lead Sponsor: The University of New South Wales

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-03-21
• Study First Submitted QC: 2012-03-22
• Study First Posted: 2012-03-23
• Study Start: 2012-06
• Primary Completion: 2015-10
• Study Completion: 2015-10
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-30
• Last Update Posted: 2015-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active tDCS	Soterix tDCS device	Active tDCS
Sham tDCS	Sham tDCS device	Sham tDCS

Primary Outcome Measures

Name	Time	Method
Montgomery Asberg Depression Rating Scale for Depression (MADRS)	12 weeks

Secondary Outcome Measures

Name	Time	Method
Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR)	12 weeks
Montreal Cognitive Assessment (MoCA): Global Cognitive Function	8 weeks

Trial Locations

Locations (6)

University of New South Wales / Black Dog Institute; 🇦🇺 Sydney, New South Wales, Australia

Emory University; 🇺🇸 Atlanta, Georgia, United States

Sheppard Pratt; 🇺🇸 Towson, Maryland, United States

Rowan University; 🇺🇸 Cherry Hill, New Jersey, United States

University of Texas Southwestern; 🇺🇸 Dallas, Texas, United States

Duke University; 🇺🇸 Durham, North Carolina, United States