Trial of Bilateral tDCS for Depression

NCT ID: NCT01849367

Last Updated: 2015-09-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2015-07-31

Brief Summary

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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

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Conditions

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Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Active tDCS (1)

Group Type EXPERIMENTAL

Eldith Neuroconn tDCS device

Intervention Type DEVICE

Active tDCS (2)

Group Type ACTIVE_COMPARATOR

Eldith Neuroconn tDCS device

Intervention Type DEVICE

Interventions

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Eldith Neuroconn tDCS device

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The University of New South Wales

OTHER

Sponsor Role lead

Responsible Party

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Colleen Loo

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Black Dog Institute / University of New South Wales

Sydney, New South Wales, Australia

Site Status

Countries

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Australia

Other Identifiers

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HC13052

Identifier Type: -

Identifier Source: org_study_id

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