NCT00763230

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

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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 68 (estimated)
• Sponsor: The University of New South Wales · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Depressive Disorder, Major
• Bipolar Disorder

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2008-04-01
• Primary completion: 2011-01-01
• Completion: 2011-01-01
• First posted: 2008-09-30
• Last updated: 2011-05-02

Locations

1 site across 1 country: Australia