Transcranial Electrical Stimulation (TES) for the Treatment of Depression.
Primary Purpose
Major Depression
Status
Completed
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Sham TES
Active TES
Sponsored by
About this trial
This is an interventional treatment trial for Major Depression
Eligibility Criteria
Inclusion Criteria:
- DSM-IV Major Depressive Episode (as part of a Major Depressive Disorder or Bipolar Disorder), of minimum 4 weeks duration.
- MADRS score ≥ 20 at study entry.
Exclusion Criteria:
- DSM-IV psychotic disorder;
- drug or alcohol abuse or dependence (preceding 12 months);
- inadequate response to ECT (current episode of depression);
- anticonvulsant or benzodiazepine medication;
- rapid clinical response required, e.g. high suicide risk; 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.
Sites / Locations
- Black Dog Institute / University of New South Wales
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
Active TES
Sham TES
Arm Description
Active TES
Sham TES
Outcomes
Primary Outcome Measures
Montgomery Asberg Depression Rating Scale for Depression (MADRS)
Secondary Outcome Measures
Beck Depression Inventory II
Full Information
NCT ID
NCT01792414
First Posted
February 13, 2013
Last Updated
February 1, 2017
Sponsor
The University of New South Wales
1. Study Identification
Unique Protocol Identification Number
NCT01792414
Brief Title
Transcranial Electrical Stimulation (TES) for the Treatment of Depression.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of New South Wales
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study is a RCT of transcranial electrical stimulation in depressed patients. 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
Major Depression
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Active TES
Arm Type
Active Comparator
Arm Description
Active TES
Arm Title
Sham TES
Arm Type
Sham Comparator
Arm Description
Sham TES
Intervention Type
Device
Intervention Name(s)
Sham TES
Intervention Description
Neuroconn Eldith device
Intervention Type
Device
Intervention Name(s)
Active TES
Intervention Description
Neuroconn Eldith device
Primary Outcome Measure Information:
Title
Montgomery Asberg Depression Rating Scale for Depression (MADRS)
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Beck Depression Inventory II
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
DSM-IV Major Depressive Episode (as part of a Major Depressive Disorder or Bipolar Disorder), of minimum 4 weeks duration.
MADRS score ≥ 20 at study entry.
Exclusion Criteria:
DSM-IV psychotic disorder;
drug or alcohol abuse or dependence (preceding 12 months);
inadequate response to ECT (current episode of depression);
anticonvulsant or benzodiazepine medication;
rapid clinical response required, e.g. high suicide risk; 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.
Facility Information:
Facility Name
Black Dog Institute / University of New South Wales
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2031
Country
Australia
12. IPD Sharing Statement
Citations:
PubMed Identifier
31899509
Citation
Nikolin S, Alonzo A, Martin D, Galvez V, Buten S, Taylor R, Goldstein J, Oxley C, Hadzi-Pavlovic D, Loo CK. Transcranial Random Noise Stimulation for the Acute Treatment of Depression: A Randomized Controlled Trial. Int J Neuropsychopharmacol. 2020 Apr 21;23(3):146-156. doi: 10.1093/ijnp/pyz072.
Results Reference
derived
Learn more about this trial
Transcranial Electrical Stimulation (TES) for the Treatment of Depression.
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