Investigating tDCS as a Treatment for Unipolar and Bipolar Depression
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ClinicalTrials.gov Identifier: NCT01562184 |
Recruitment Status :
Completed
First Posted : March 23, 2012
Last Update Posted : December 2, 2015
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Unipolar Depression Bipolar Depression | Device: Sham tDCS device Device: Soterix tDCS device | Phase 2 Phase 3 |
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 |

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 |
- Montgomery Asberg Depression Rating Scale for Depression (MADRS) [ Time Frame: 12 weeks ]
- Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR) [ Time Frame: 12 weeks ]
- Montreal Cognitive Assessment (MoCA): Global Cognitive Function [ Time Frame: 8 weeks ]

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

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
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 |
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 |
Depression Depressive Disorder Bipolar Disorder Behavioral Symptoms |
Mood Disorders Mental Disorders Bipolar and Related Disorders |