Depression and Transcranial Direct Current Stimulation (tDCS)

NCT ID: NCT00256438

Last Updated: 2006-07-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-02-28

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.

Conditions

Depression

Keywords

Depression; Transcranial Direct Current Stimulation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

Transcranial Direct Current Stimulation

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The University of New South Wales

OTHER

Sponsor Role: lead

Principal Investigators

Perminder P Sachdev, FRANZCP PhD

Role: PRINCIPAL_INVESTIGATOR

University of NSW

Colleen K Loo, FRANZCP, MD

Role: PRINCIPAL_INVESTIGATOR

University of NSW

Locations

Black Dog Institute Building, School of Psychiatry, University of NSW

Sydney, New South Wales, Australia

Site Status: RECRUITING

Countries

Australia

Central Contacts

Colleen K Loo, FRANZCP, MD

Role: CONTACT

Phone: 02 9382 3721

Email: colleen.loo@unsw.edu.au

Perminder P Sachdev, FRANZCP PhD

Role: CONTACT

Phone: 02 9382 3763

Email: p.sachdev@unsw.edu.au

Facility Contacts

Melissa Pigot, BSc

Role: primary

Other Identifiers

05125

Identifier Type: -

Identifier Source: org_study_id