Trial of Bilateral tDCS for Depression

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01849367

Enrollment

Registered

2013-05-08

Start date

2013-05-31

Completion date

2015-07-31

Last updated

2015-09-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression

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.

Interventions

DEVICEEldith Neuroconn tDCS device

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Montgomery Asberg Depression Rating Scale for Depression (MADRS)	4 weeks

Secondary

Measure	Time frame
Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR)	4 weeks

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026