A Study of Transcranial Direct Current Stimulation (tDCS) to Treat Depression

Bipolar Disorder Clinical Trial

Official title:

A Sham-controlled Study of Transcranial Direct Current Stimulation (tDCS) as a Treatment for Depression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00763230
• Other study ID #: 07305
• Secondary ID: NHMRC (Australia
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: September 26, 2008
• Last updated: April 29, 2011
• Start date: April 2008
• Est. completion date: January 2011

Study information

• Verified date: March 2011
• Source: The University of New South Wales
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial Summary

Depression is a common illness with an approximate lifetime prevalence of 17 %, conferring a large burden of disease in the community, often due to inadequate treatment. Thus there is interest in the therapeutic potential of non invasive, novel forms of brain stimulation, such as transcranial direct current stimulation (tDCS). Two small studies have been published in the last two years indicating that 20 minutes of either 1 or 2mA tDCS over 5 or 10 sessions is safe, painless and well tolerated. The investigators' own pilot data (N=30) also suggests the technique has antidepressant effects and is safe (5-10 sessions of tDCS at 1 mA).

This study will extend previous findings, testing a more definitive tDCS approach (also left prefrontal anodal stimulation) with a longer treatment course (15 sessions), at 2 mA (which has been found to be safe and more effective than 1 mA in cognitive studies), and in a larger sample (N=68), using a placebo-controlled design.

It is hypothesised that active tDCS (15 sessions) will have greater efficacy than sham treatment (15 sessions) in reducing the severity of depressive symptoms in patients in an episode of major depression. A second hypothesis is that 15 sessions of tDCS will not cause any significant adverse effects or cause decline in neuropsychological functioning in comparison to a sham control.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Meets criteria for DSM-IV Major Depressive Episode

Exclusion Criteria:

• Diagnosis (as defined by DSM-IV) of: any psychotic disorder except bipolar 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.

• Subject is on regular benzodiazepine medication which it is not clinically appropriate to discontinue.

• Subject requires a rapid clinical response due to inanition, psychosis or high suicide risk.

• Neurological disorder or insult, eg recent stroke (CVA), which places subject at risk of seizure or neuronal damage with tDCS.

• Subject has metal in the cranium, skull defects, or skin lesions on scalp (cuts, abrasions, rash) at proposed electrode sites.

• Female subject who is pregnant, or of child-bearing age, sexually active and not using reliable contraception

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bipolar Disorder
• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Disease

Intervention

Device:
• Transcranial direct current stimulation
tDCS will be given every weekday. For each session, tDCS will be given continuously for 20 minutes at 2 mA. Conductive rubber electrodes (7 x 5 cm, 35 cm2) covered by sponges soaked in saline will be used, held in place by a head band. The current will be gradually increased to the level of 2 mA over 30 seconds (to avoid the sensation of a flash as described in the safety section above). For sham stimulation, the current will be left on for another 30s, then gradually reduced to zero over another 30 seconds, so that the initial tingling sensation experienced by subjects will be identical for the two groups. The stimulator will be placed behind the subject's head so any adjustments to the current by the operator are not evident. This sham procedure resulted in successful blinding in our pilot study.

Locations

Country	Name	City	State
Australia	Black Dog Institute, University of New South Wales	Randwick	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)	Baseline (pre-treatment), post 8, 15, 23 and 30 tDCS sessions, and follow-up 1 week, 1 month, 3 months and 6 months post treatment	6 months	No
Secondary	Inventory of Depressive Symptomatology (IDS-C)	Baseline (pre-treatment), post 8, 15, 23 and 30 tDCS sessions, and follow-up 1 week, 1 month, 3 months and 6 months post treatment	6 months	No
Secondary	Quick Inventory of Depressive Symptomatology - Self rated (QIDS-SR)		Baseline (pre-treatment), post 8, 15, 23 and 30 tDCS sessions, and follow-up 1 week, 1 month, 3 months and 6 months post treatment	No

External Links

•   Black Dog Institute website