Trial of Bilateral tDCS for Depression

Phase 1

Completed

• Conditions: Depression
• Interventions: Device: Eldith Neuroconn tDCS device

• Registration Number: NCT01849367
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-05
• Study First Submitted: 2013-05-05
• Study First Submitted QC: 2013-05-07
• Study First Posted: 2013-05-08
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-15
• Last Update Posted: 2015-09-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active tDCS (1)	Eldith Neuroconn tDCS device	-
Active tDCS (2)	Eldith Neuroconn tDCS device	-

Primary Outcome Measures

Name	Time	Method
Montgomery Asberg Depression Rating Scale for Depression (MADRS)	4 weeks

Secondary Outcome Measures

Name	Time	Method
Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR)	4 weeks

Trial Locations

Locations (1)

Black Dog Institute / University of New South Wales; 🇦🇺 Sydney, New South Wales, Australia