We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

Investigating tDCS as a Treatment for Unipolar and Bipolar Depression

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01562184
Recruitment Status : Completed
First Posted : March 23, 2012
Last Update Posted : December 2, 2015
Information provided by (Responsible Party):

March 21, 2012
March 23, 2012
December 2, 2015
June 2012
October 2015   (Final data collection date for primary outcome measure)
Montgomery Asberg Depression Rating Scale for Depression (MADRS) [ Time Frame: 12 weeks ]
Same as current
Complete list of historical versions of study NCT01562184 on ClinicalTrials.gov Archive Site
  • Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR) [ Time Frame: 12 weeks ]
  • Montreal Cognitive Assessment (MoCA): Global Cognitive Function [ Time Frame: 8 weeks ]
Same as current
Not Provided
Not Provided
Investigating tDCS as a Treatment for Unipolar and Bipolar Depression
A Controlled Trial of Transcranial Direct Current Stimulation as a Treatment for Unipolar and Bipolar Depression
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.
Not Provided
Phase 2
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Unipolar Depression
  • Bipolar Depression
  • Device: Sham tDCS device
    Sham tDCS
  • Device: Soterix tDCS device
    Active tDCS
  • Active Comparator: Active tDCS
    Active tDCS
    Intervention: Device: Soterix tDCS device
  • Sham Comparator: Sham tDCS
    Sham tDCS
    Intervention: Device: Sham tDCS device
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
October 2015
October 2015   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Australia,   United States
#11T-005 ( Other Grant/Funding Number: Stanley Medical Research Institute )
Not Provided
Not Provided
Colleen Loo, The University of New South Wales
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
Not Provided
The University of New South Wales
November 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP