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Trial of Bilateral tDCS for 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: NCT01849367
Recruitment Status : Completed
First Posted : May 8, 2013
Last Update Posted : September 17, 2015
Sponsor:
Information provided by (Responsible Party):
Colleen Loo, The University of New South Wales

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. Mood, cognitive test performance and biomarkers will be measured during the trial.

Condition or disease Intervention/treatment Phase
Depression Device: Eldith Neuroconn tDCS device Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : May 2013
Actual Primary Completion Date : July 2015
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Active tDCS (1) Device: Eldith Neuroconn tDCS device
Active Comparator: Active tDCS (2) Device: Eldith Neuroconn tDCS device



Primary Outcome Measures :
  1. Montgomery Asberg Depression Rating Scale for Depression (MADRS) [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  1. Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR) [ Time Frame: 4 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:

  1. Participant meets criteria for a DSM-IV Major Depressive episode.
  2. MADRS score of 20 or more.

Exclusion Criteria:

  1. Diagnosis (as defined by DSM-IV) of: any psychotic disorder (lifetime); eating disorder (current or within the past year); obsessive compulsive disorder (lifetime); post-traumatic stress disorder (current or within the past year); mental retardation.
  2. History of drug or alcohol abuse or dependence (as per DSM-IV criteria) within the last 3 months (except nicotine and caffeine).
  3. Inadequate response to ECT in the current episode of depression.
  4. Participant is on regular benzodiazepine medication which is not clinically appropriate to discontinue.
  5. Participant requires a rapid clinical response due to inanition, psychosis or high suicide risk.
  6. Neurological disorder or insult, e.g., recent stroke (CVA), which places participant at risk of seizure or neuronal damage with tDCS.
  7. Participant has metal in the cranium, skull defects, or skin lesions on scalp (cuts, abrasions, rash) at proposed electrode sites.
  8. Female participant who is pregnant, or of child-bearing age, sexually active and not using reliable contraception (urine test for pregnancy will be used).
  9. Participants who are not fluent in English will not be included in the trial for safety reasons.

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): NCT01849367


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

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Responsible Party: Colleen Loo, Professor, The University of New South Wales
ClinicalTrials.gov Identifier: NCT01849367     History of Changes
Other Study ID Numbers: HC13052
First Posted: May 8, 2013    Key Record Dates
Last Update Posted: September 17, 2015
Last Verified: September 2015

Additional relevant MeSH terms:
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Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders