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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
Sponsor:
Collaborators:
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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Unipolar Depression Bipolar Depression Device: Sham tDCS device Device: Soterix tDCS device Phase 2 Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (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
Study Start Date : June 2012
Actual Primary Completion Date : October 2015
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Active tDCS
Active tDCS
 Device: Soterix tDCS device
Active tDCS
Sham Comparator: Sham tDCS
Sham tDCS
 Device: Sham tDCS device
Sham tDCS


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

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

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01562184


Locations
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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
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Colleen Loo, Professor, The University of New South Wales
ClinicalTrials.gov Identifier: NCT01562184    
Other Study ID Numbers: HC11515
#11T-005 ( Other Grant/Funding Number: Stanley Medical Research Institute )
First Posted: March 23, 2012    Key Record Dates
Last Update Posted: December 2, 2015
Last Verified: November 2015
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Bipolar Disorder
Behavioral Symptoms
 Mood Disorders
Mental Disorders
Bipolar and Related Disorders