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Transcranial Electrical Stimulation (TES) for the Treatment of Depression.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01792414
Recruitment Status : Completed
First Posted : February 15, 2013
Last Update Posted : February 2, 2017
Sponsor:
Information provided by (Responsible Party):
Colleen Loo, The University of New South Wales

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.

Condition or disease Intervention/treatment Phase
Major Depression Device: Sham TES Device: Active TES Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : January 2013
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Active TES
Active TES
Device: Active TES
Neuroconn Eldith device

Sham Comparator: Sham TES
Sham TES
Device: Sham TES
Neuroconn Eldith device




Primary Outcome Measures :
  1. Montgomery Asberg Depression Rating Scale for Depression (MADRS) [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Beck Depression Inventory II [ Time Frame: 12 weeks ]


Information from the National Library of Medicine

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

Information from the National Library of Medicine

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): NCT01792414


Locations
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Australia, New South Wales
Black Dog Institute / University of New South Wales
Sydney, New South Wales, Australia, 2031
Sponsors and Collaborators
The University of New South Wales

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Colleen Loo, Professor, The University of New South Wales
ClinicalTrials.gov Identifier: NCT01792414    
Other Study ID Numbers: HC12143
First Posted: February 15, 2013    Key Record Dates
Last Update Posted: February 2, 2017
Last Verified: February 2017
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders