Investigating tDCS as a Treatment for Unipolar and Bipolar Depression
NCT ID: NCT01562184
Last Updated: 2015-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2/PHASE3
120 participants
INTERVENTIONAL
2012-06-30
2015-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Active tDCS
Active tDCS
Soterix tDCS device
Active tDCS
Sham tDCS
Sham tDCS
Sham tDCS device
Sham tDCS
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Sham tDCS device
Sham tDCS
Soterix tDCS device
Active tDCS
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Duke University
OTHER
Emory University
OTHER
Sheppard Pratt Health System
OTHER
University of Medicine and Dentistry of New Jersey
OTHER
University of Texas
OTHER
The University of New South Wales
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Colleen Loo
Professor
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Emory University
Atlanta, Georgia, United States
Sheppard Pratt
Towson, Maryland, United States
Rowan University
Cherry Hill, New Jersey, United States
Duke University
Durham, North Carolina, United States
University of Texas Southwestern
Dallas, Texas, United States
University of New South Wales / Black Dog Institute
Sydney, New South Wales, Australia
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Martin DM, McClintock SM, Aaronson ST, Alonzo A, Husain MM, Lisanby SH, McDonald WM, Mohan A, Nikolin S, O'Reardon J, Weickert CS, Loo CK. Pre-treatment attentional processing speed and antidepressant response to transcranial direct current stimulation: Results from an international randomized controlled trial. Brain Stimul. 2018 Nov-Dec;11(6):1282-1290. doi: 10.1016/j.brs.2018.08.011. Epub 2018 Aug 23.
Loo CK, Husain MM, McDonald WM, Aaronson S, O'Reardon JP, Alonzo A, Weickert CS, Martin DM, McClintock SM, Mohan A, Lisanby SH; International Consortium of Research in tDCS (ICRT). International randomized-controlled trial of transcranial Direct Current Stimulation in depression. Brain Stimul. 2018 Jan-Feb;11(1):125-133. doi: 10.1016/j.brs.2017.10.011. Epub 2017 Oct 27.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
#11T-005
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
HC11515
Identifier Type: -
Identifier Source: org_study_id