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Investigating tDCS as a Treatment for Unipolar and Bipolar Depression

This study has been completed.
Duke University
Emory University
Sheppard Pratt Health System
University of Medicine and Dentistry of New Jersey
University of Texas
Information provided by (Responsible Party):
Colleen Loo, The University of New South Wales Identifier:
First received: March 21, 2012
Last updated: November 30, 2015
Last verified: November 2015
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.

Condition Intervention Phase
Unipolar Depression
Bipolar Depression
Device: Sham tDCS device
Device: Soterix tDCS device
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Controlled Trial of Transcranial Direct Current Stimulation as a Treatment for Unipolar and Bipolar Depression

Further study details as provided by Colleen Loo, The University of New South Wales:

Primary Outcome Measures:
  • Montgomery Asberg Depression Rating Scale for Depression (MADRS) [ Time Frame: 12 weeks ]

Secondary Outcome Measures:
  • Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR) [ Time Frame: 12 weeks ]
  • Montreal Cognitive Assessment (MoCA): Global Cognitive Function [ Time Frame: 8 weeks ]

Enrollment: 120
Study Start Date: June 2012
Study Completion Date: October 2015
Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Active tDCS
Active tDCS
Device: Soterix tDCS device
Active tDCS
Sham Comparator: Sham tDCS
Sham tDCS
Device: Sham tDCS device
Sham tDCS


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts 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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01562184

United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322
United States, Maryland
Sheppard Pratt
Towson, Maryland, United States, 21285
United States, New Jersey
Rowan University
Cherry Hill, New Jersey, United States, 08002
United States, North Carolina
Duke University
Durham, North Carolina, United States, 27710
United States, Texas
University of Texas Southwestern
Dallas, Texas, United States, 75390
Australia, New South Wales
University of New South Wales / Black Dog Institute
Sydney, New South Wales, Australia, 2031
Sponsors and Collaborators
The University of New South Wales
Duke University
Emory University
Sheppard Pratt Health System
University of Medicine and Dentistry of New Jersey
University of Texas
  More Information

Additional Information:
Responsible Party: Colleen Loo, Professor, The University of New South Wales Identifier: NCT01562184     History of Changes
Other Study ID Numbers: HC11515
#11T-005 ( Other Grant/Funding Number: Stanley Medical Research Institute )
Study First Received: March 21, 2012
Last Updated: November 30, 2015

Additional relevant MeSH terms:
Depressive Disorder
Bipolar Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Bipolar and Related Disorders processed this record on May 25, 2017