Investigating tDCS as a Treatment for Unipolar and Bipolar Depression
This study is currently recruiting participants.
Verified May 2013 by The University of New South Wales
Sponsor:
The University of New South Wales
Collaborators:
Duke University
Emory University
Sheppard Pratt Health System
University of Medicine and Dentistry 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: May 5, 2013
Last verified: May 2013
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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 |
Resource links provided by NLM:
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
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: Sabrina Stair 404-728-6856 sstair@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 | |
| University of Medicine and Dentistry of New Jersey | Recruiting |
| Cherry Hill, New Jersey, United States, 08002 | |
| Contact: Sarah deVries cmdnt@umdnj.edu | |
| Principal Investigator: John O'Reardon, MD | |
| United States, North Carolina | |
| Duke University | Recruiting |
| Durham, North Carolina, United States, 27710 | |
| Contact: Rosa Jou-Zhang rosa.jouzhang@duke.edu | |
| Principal Investigator: Sarah Lisanby, MD | |
| United States, Texas | |
| University of Texas Southwestern | Recruiting |
| Dallas, Texas, United States, 75390 | |
| Contact: Kenneth Trevino, PhD Kenneth.Trevino@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 New Jersey
University of Texas
More Information
Additional Information:
Related Info 
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: | May 5, 2013 |
| 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 |
Mood Disorders Mental Disorders Behavioral Symptoms |
ClinicalTrials.gov processed this record on May 23, 2013