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Investigating tDCS as a Treatment for Unipolar and Bipolar Depression

Primary Purpose

Unipolar Depression, Bipolar Depression

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Sham tDCS device
Soterix tDCS device
Sponsored by
The University of New South Wales
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Unipolar Depression

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Emory University
  • Sheppard Pratt
  • Rowan University
  • Duke University
  • University of Texas Southwestern
  • University of New South Wales / Black Dog Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Active tDCS

Sham tDCS

Arm Description

Active tDCS

Sham tDCS

Outcomes

Primary Outcome Measures

Montgomery Asberg Depression Rating Scale for Depression (MADRS)

Secondary Outcome Measures

Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR)
Montreal Cognitive Assessment (MoCA): Global Cognitive Function

Full Information

First Posted
March 21, 2012
Last Updated
November 30, 2015
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
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1. Study Identification

Unique Protocol Identification Number
NCT01562184
Brief Title
Investigating tDCS as a Treatment for Unipolar and Bipolar Depression
Official Title
A Controlled Trial of Transcranial Direct Current Stimulation as a Treatment for Unipolar and Bipolar Depression
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
October 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the 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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Unipolar Depression, Bipolar Depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active tDCS
Arm Type
Active Comparator
Arm Description
Active tDCS
Arm Title
Sham tDCS
Arm Type
Sham Comparator
Arm Description
Sham tDCS
Intervention Type
Device
Intervention Name(s)
Sham tDCS device
Intervention Description
Sham tDCS
Intervention Type
Device
Intervention Name(s)
Soterix tDCS device
Intervention Description
Active tDCS
Primary Outcome Measure Information:
Title
Montgomery Asberg Depression Rating Scale for Depression (MADRS)
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR)
Time Frame
12 weeks
Title
Montreal Cognitive Assessment (MoCA): Global Cognitive Function
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Sheppard Pratt
City
Towson
State/Province
Maryland
ZIP/Postal Code
21285
Country
United States
Facility Name
Rowan University
City
Cherry Hill
State/Province
New Jersey
ZIP/Postal Code
08002
Country
United States
Facility Name
Duke University
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
University of Texas Southwestern
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
University of New South Wales / Black Dog Institute
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2031
Country
Australia

12. IPD Sharing Statement

Citations:
PubMed Identifier
30172724
Citation
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.
Results Reference
derived
PubMed Identifier
29111077
Citation
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.
Results Reference
derived

Learn more about this trial

Investigating tDCS as a Treatment for Unipolar and Bipolar Depression

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