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Clinical Trials/NCT00256438
NCT00256438
Unknown
Phase 1

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

The University of New South Wales1 site in 1 country20 target enrollmentFebruary 2006
ConditionsDepression

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Depression
Sponsor
The University of New South Wales
Enrollment
20
Locations
1
Primary Endpoint
All measures at baseline and after each 5 treatments:
Last Updated
19 years ago

Overview

Brief 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.

Detailed 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.

Registry
clinicaltrials.gov
Start Date
February 2006
End Date
TBD
Last Updated
19 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility Criteria

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

Outcomes

Primary Outcomes

All measures at baseline and after each 5 treatments:

Montgomery& Asberg Depression Rating Scale

Hamilton Psychiatric Rating Scale for Depression

Clinical Global Impression-Severity

Beck Depression Inventory

Patient Global Impression-Severity

Secondary Outcomes

  • Neuropsychological assessment at baseline and after each 5 treatments:
  • Rey Auditory Verbal Learning Task
  • Digit span
  • Trail Making Test
  • Controlled Oral Word Association

Study Sites (1)

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