Investigating tDCS as a Treatment for Unipolar and Bipolar Depression

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by The University of New South Wales
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
ClinicalTrials.gov Identifier:
NCT01562184
First received: March 21, 2012
Last updated: August 27, 2014
Last verified: August 2014
  Purpose

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 (Subject, Caregiver, 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 The University of New South Wales:

Primary Outcome Measures:
  • Montgomery Asberg Depression Rating Scale for Depression (MADRS) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Montreal Cognitive Assessment (MoCA): Global Cognitive Function [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: June 2012
Estimated Primary Completion Date: March 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01562184

Contacts
Contact: Angelo Alonzo, PhD 61-2-93823720 a.alonzo@unsw.edu.au
Contact: Donel Martin, PhD 61-2-93829261 donel.martin@unsw.edu.au

Locations
United States, Georgia
Emory University Recruiting
Atlanta, Georgia, United States, 30322
Contact: Gail Galendez    404-728-6856    gail.snead@emory.edu   
Principal Investigator: William McDonald, MD         
United States, Maryland
Sheppard Pratt Recruiting
Towson, Maryland, United States, 21285
Contact: Jennifer Sklar       JSklar@sheppardpratt.org   
Principal Investigator: Scott Aaronson, MD         
United States, New Jersey
Rowan University Recruiting
Cherry Hill, New Jersey, United States, 08002
Contact: Michelle Moyer, MD       moyerml@rowan.edu   
Principal Investigator: John O'Reardon, MD         
United States, North Carolina
Duke University Recruiting
Durham, North Carolina, United States, 27710
Contact: Michael Koval       michael.koval@duke.edu   
Principal Investigator: Sarah Lisanby, MD         
United States, Texas
University of Texas Southwestern Recruiting
Dallas, Texas, United States, 75390
Contact: Ankita Vora, MD       Ankita.Vora@UTSouthwestern.edu   
Principal Investigator: Mustafa Husain, MD         
Australia, New South Wales
University of New South Wales / Black Dog Institute Recruiting
Sydney, New South Wales, Australia, 2031
Contact: Angelo Alonzo, PhD    61-2-93823720    a.alonzo@unsw.edu.au   
Principal Investigator: Colleen Loo, FRANZCP         
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:
No publications provided

Responsible Party: Colleen Loo, Professor, The University of New South Wales
ClinicalTrials.gov Identifier: NCT01562184     History of Changes
Other Study ID Numbers: HC11515, #11T-005
Study First Received: March 21, 2012
Last Updated: August 27, 2014
Health Authority: Australia: Human Research Ethics Committee
Australia: Department of Health and Ageing Therapeutic Goods Administration

Additional relevant MeSH terms:
Bipolar Disorder
Depression
Depressive Disorder
Affective Disorders, Psychotic
Behavioral Symptoms
Mental Disorders
Mood Disorders

ClinicalTrials.gov processed this record on October 23, 2014