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Open Pilot Trial of TES for Depression

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01201148
First Posted: September 14, 2010
Last Update Posted: December 2, 2015
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.
Information provided by (Responsible Party):
Colleen Loo, The University of New South Wales
September 8, 2010
September 14, 2010
December 2, 2015
September 2010
September 2015   (Final data collection date for primary outcome measure)
Montgomery Asberg Depression Rating Scale for Depression (MADRS) [ Time Frame: 6 months ]
Same as current
Complete list of historical versions of study NCT01201148 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Open Pilot Trial of TES for Depression
A Study of Transcranial Electrical Stimulation (TES) for the Treatment of Depression
This study will investigate whether using oscillating TES (random noise stimulation) or intermittent tDCS will have greater antidepressant effects in depressed subjects, compared to standard tDCS.
Not Provided
Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Major Depression
Device: tDCS (Eldith DC-Stimulator (CE certified))
For participants receiving intermittent tDCS or oscillating TES, one electrode will be placed over the left pF3 electrode site (overlying the left dorsolateral prefrontal cortex and identified on the scalp using an EEG cap based on the 10/20 system) and the other over the right temporal area.
Experimental: Oscillating or intermittent tDCS
Intervention: Device: tDCS (Eldith DC-Stimulator (CE certified))
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
7
September 2015
September 2015   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subject meets criteria for a DSM-IV Major Depressive episode.

Exclusion Criteria:

  • Diagnosis (as defined by DSM-IV) of: any psychotic disorder (lifetime); bipolar disorder; eating disorder (current or within the past year); obsessive compulsive disorder (lifetime); post-traumatic stress disorder (current or within the past year); mental retardation.
  • Subject has not responded adequately to standard tDCS or is not appropriate for trial of standard tDCS (eg depression too chronic in duration)
  • Total MADRS depression score of 20 or more
  • History of drug or alcohol abuse or dependence (as per DSM-IV criteria) within the last 3 months (except nicotine and caffeine).
  • Inadequate response to ECT in the current episode of depression.
  • Subject is on regular benzodiazepine medication which it is not clinically appropriate to discontinue.
  • Subject requires a rapid clinical response due to inanition, psychosis or high suicide risk.
  • Neurological disorder or insult, e.g., recent stroke (CVA), which places subject at risk of seizure or neuronal damage with TES.
  • Subject has metal in the cranium, skull defects, or skin lesions on scalp (cuts, abrasions, rash) at proposed electrode sites.
  • Female subject who is pregnant. However, women of child bearing age are eligible if they have the pregnancy test but will be excluded if they are sexually active and not using reliable contraception (urine test for pregnancy will be used if appropriate).
Sexes Eligible for Study: All
18 Years to 85 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Australia
 
 
NCT01201148
10231
Yes
Not Provided
Not Provided
Colleen Loo, The University of New South Wales
The University of New South Wales
Not Provided
Principal Investigator: Colleen Loo, MBBS School of Psychiatry, University of New South Wales
The University of New South Wales
November 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP