Trial of Bilateral tDCS for Depression
1 other identifier
interventional
4
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 depression
Started May 2013
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2013
CompletedFirst Submitted
Initial submission to the registry
May 5, 2013
CompletedFirst Posted
Study publicly available on registry
May 8, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2015
CompletedSeptember 17, 2015
September 1, 2015
2.2 years
May 5, 2013
September 15, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Montgomery Asberg Depression Rating Scale for Depression (MADRS)
4 weeks
Secondary Outcomes (1)
Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR)
4 weeks
Study Arms (2)
Active tDCS (1)
EXPERIMENTALActive tDCS (2)
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Participant meets criteria for a DSM-IV Major Depressive episode.
- MADRS score of 20 or more.
You may not qualify if:
- 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.
- 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.
- Participant is on regular benzodiazepine medication which is not clinically appropriate to discontinue.
- Participant requires a rapid clinical response due to inanition, psychosis or high suicide risk.
- Neurological disorder or insult, e.g., recent stroke (CVA), which places participant at risk of seizure or neuronal damage with tDCS.
- Participant has metal in the cranium, skull defects, or skin lesions on scalp (cuts, abrasions, rash) at proposed electrode sites.
- Female participant who is pregnant, or of child-bearing age, sexually active and not using reliable contraception (urine test for pregnancy will be used).
- Participants who are not fluent in English will not be included in the trial for safety reasons.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Black Dog Institute / University of New South Wales
Sydney, New South Wales, 2031, Australia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
May 5, 2013
First Posted
May 8, 2013
Study Start
May 1, 2013
Primary Completion
July 1, 2015
Study Completion
July 1, 2015
Last Updated
September 17, 2015
Record last verified: 2015-09