NCT00256438

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1 depression

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 17, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 21, 2005

Completed
2 months until next milestone

Study Start

First participant enrolled

February 1, 2006

Completed
Last Updated

July 10, 2006

Status Verified

July 1, 2006

First QC Date

November 17, 2005

Last Update Submit

July 6, 2006

Conditions

Keywords

DepressionTranscranial Direct Current Stimulation

Outcome Measures

Primary Outcomes (6)

  • 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 (5)

  • Neuropsychological assessment at baseline and after each 5 treatments:

  • Rey Auditory Verbal Learning Task

  • Digit span

  • Trail Making Test

  • Controlled Oral Word Association

Interventions

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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  • On antipsychotic, anticonvulsant or benzodiazepine medication which cannot be withdrawn.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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Sydney, New South Wales, 2031, Australia

RECRUITING

MeSH Terms

Conditions

Depression

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Study Officials

  • Perminder P Sachdev, FRANZCP PhD

    University of NSW

    PRINCIPAL INVESTIGATOR
  • Colleen K Loo, FRANZCP, MD

    University of NSW

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Colleen K Loo, FRANZCP, MD

CONTACT

Perminder P Sachdev, FRANZCP PhD

CONTACT

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 17, 2005

First Posted

November 21, 2005

Study Start

February 1, 2006

Last Updated

July 10, 2006

Record last verified: 2006-07

Locations