Investigating tDCS as a Treatment for Unipolar and Bipolar Depression
This study has been completed.
Sponsor:
The University of New South Wales
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: November 30, 2015
Last verified: November 2015
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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 |
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 ]
| Enrollment: | 120 |
| Study Start Date: | June 2012 |
| Study Completion Date: | October 2015 |
| Primary Completion Date: | October 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 (Adult, Senior) |
| 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
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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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01562184
Locations
| 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
Additional Information:
| 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: | November 30, 2015 |
| Health Authority: | Australia: Human Research Ethics Committee Australia: Department of Health and Ageing Therapeutic Goods Administration |
Additional relevant MeSH terms:
|
Depression Depressive Disorder Bipolar Disorder Behavioral Symptoms |
Mood Disorders Mental Disorders Bipolar and Related Disorders |
ClinicalTrials.gov processed this record on September 30, 2016