Trial of Bilateral tDCS for Depression

Depression Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01849367
• Other study ID #: HC13052
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: May 5, 2013
• Last updated: September 15, 2015
• Start date: May 2013
• Est. completion date: July 2015

Study information

• Verified date: September 2015
• Source: The University of New South Wales
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Human Research Ethics CommitteeAustralia: Department of Health and Ageing Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression

Intervention

Device:
• Eldith Neuroconn tDCS device

Locations

Country	Name	City	State
Australia	Black Dog Institute / University of New South Wales	Sydney	New South Wales

Sponsors (1)

Lead Sponsor	Collaborator
The University of New South Wales

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Montgomery Asberg Depression Rating Scale for Depression (MADRS)		4 weeks	No
Secondary	Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR)		4 weeks	No