Depression and Transcranial Direct Current Stimulation (tDCS)

Depression Clinical Trial

Official title:

The Treatment of Depression Using Transcranial Direct Current Stimulation (tDCS): a Pilot Study.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00256438
• Other study ID #: 05125
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: November 17, 2005
• Last updated: July 6, 2006
• Start date: February 2006

Study information

• Verified date: July 2006
• Source: The University of New South Wales
• Contact: Colleen K Loo, FRANZCP, MD
• Phone: 02 9382 3721
• Email: colleen.loo[@]unsw.edu.au
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial Summary

Transcranial direct current stimulation (tDCS)is a non invasive technique which uses a very weak current to change excitability in targeted regions of the brain. Early studies suggest that it has antidepressant properties. This study will test the safety and efficacy of tDCS as a treatment for depression.

Description:

Transcranial direct current stimulation (tDCS) applies a weak direct current across the scalp that can produce sub-threshold changes in the excitability of targeted cortical regions, in a polarity-specific manner. This technique has been used in humans to alter motor and visual cortex excitability, during stimulation, and for a period after the stimulation has ceased. It has therefore been suggested as a possible treatment for depression (Lippold & Redfearn, 1964; Nitsche, 2002). Studies have been launched recently to examine the effect of tDCS in depressed subjects and a sham-controlled pilot study (in USA, in press) has reported promising antidepressant effects with tDCS.

We wish to examine this in an investigation of 20 subjects, and hypothesise that tDCS will have an antidepressant effect and produce no neuropsychological impairment. Subjects will receive anodal DC stimulation or sham stimulation over the left prefrontal cortex in a double-blind, placebo-controlled design over 5 days, and then have daily stimulation up to a maximum of 10 active sessions in total. Outcomes will be formally evaluated by depression rating scales and neuropsychological tests.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• DSM-IV Major Depressive Episode of less than or equal to 3 years

• Montgomery-Asberg Depression Rating Scale score of 25 or more

• Aged 18-65

• May or may not be taking antidepressant medication

Exclusion Criteria:

• Not able to give written informed consent

• Failure to respond to ECT in current or past episodes of depression

• On antipsychotic, anticonvulsant or benzodiazepine medication which cannot be withdrawn.

• Significant other Axis I psychiatric disorder e.g schizophrenia, bipolar

• In imminent physical or psychological danger and needs a rapid clinical response due to inanition, psychosis or high suicidality

• Drug or alcohol dependence or abuse currently or in the last 12 months

• History of neurological illness e.g epilepsy; neurosurgical procedure

• Metal in the cranium, pacemaker, cochlear implant, medication or other electronic device in the body

• Woman of child-bearing age in whom pregnancy cannot be ruled out by B HCG

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Device:
• Transcranial Direct Current Stimulation

Locations

Country	Name	City	State
Australia	Black Dog Institute Building, School of Psychiatry, University of NSW	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	All measures at baseline and after each 5 treatments:
Primary	Montgomery& Asberg Depression Rating Scale
Primary	Hamilton Psychiatric Rating Scale for Depression
Primary	Clinical Global Impression-Severity
Primary	Beck Depression Inventory
Primary	Patient Global Impression-Severity
Secondary	Neuropsychological assessment at baseline and after each 5 treatments:
Secondary	Rey Auditory Verbal Learning Task
Secondary	Digit span
Secondary	Trail Making Test
Secondary	Controlled Oral Word Association