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

This study has been completed.
Sponsor:
Information provided by:
The University of New South Wales
ClinicalTrials.gov Identifier:
NCT00763230
First received: September 26, 2008
Last updated: April 29, 2011
Last verified: March 2011
  Purpose

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.


Condition Intervention Phase
Depressive Disorder, Major
Bipolar Disorder
Device: Transcranial direct current stimulation
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Sham-controlled Study of Transcranial Direct Current Stimulation (tDCS) as a Treatment for Depression

Resource links provided by NLM:


Further study details as provided by The University of New South Wales:

Primary Outcome Measures:
  • Montgomery Asberg Depression Rating Scale for Depression (MADRS) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Baseline (pre-treatment), post 8, 15, 23 and 30 tDCS sessions, and follow-up 1 week, 1 month, 3 months and 6 months post treatment


Secondary Outcome Measures:
  • Inventory of Depressive Symptomatology (IDS-C) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Baseline (pre-treatment), post 8, 15, 23 and 30 tDCS sessions, and follow-up 1 week, 1 month, 3 months and 6 months post treatment

  • Quick Inventory of Depressive Symptomatology - Self rated (QIDS-SR) [ Time Frame: Baseline (pre-treatment), post 8, 15, 23 and 30 tDCS sessions, and follow-up 1 week, 1 month, 3 months and 6 months post treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 68
Study Start Date: April 2008
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: active
Full active tDCS treatment
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.
Other Name: Eldith DC-Stimulator (CE certified)
Sham Comparator: sham
Placebo tDCS will be give
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.
Other Name: Eldith DC-Stimulator (CE certified)

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Meets criteria for DSM-IV Major Depressive Episode

Exclusion Criteria:

  • Diagnosis (as defined by DSM-IV) of: any psychotic disorder except bipolar disorder(lifetime); eating disorder (current or within the past year); obsessive compulsive disorder (lifetime); post-traumatic stress disorder (current or within the past year); mental retardation.
  • History of drug or alcohol abuse or dependence (as per DSM-IV criteria) within the last 3 months (except nicotine and caffeine).
  • Inadequate response to ECT in the current episode of depression.
  • Subject is on regular benzodiazepine medication which it is not clinically appropriate to discontinue.
  • Subject requires a rapid clinical response due to inanition, psychosis or high suicide risk.
  • Neurological disorder or insult, eg recent stroke (CVA), which places subject at risk of seizure or neuronal damage with tDCS.
  • Subject has metal in the cranium, skull defects, or skin lesions on scalp (cuts, abrasions, rash) at proposed electrode sites.
  • Female subject who is pregnant, or of child-bearing age, sexually active and not using reliable contraception
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00763230

Locations
Australia, New South Wales
Black Dog Institute, University of New South Wales
Randwick, New South Wales, Australia, 2031
Sponsors and Collaborators
The University of New South Wales
Investigators
Principal Investigator: Colleen Loo University of New South Wales
  More Information

Additional Information:
No publications provided by The University of New South Wales

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Associate Professor Colleen Loo, University of New South Wales
ClinicalTrials.gov Identifier: NCT00763230     History of Changes
Other Study ID Numbers: 07305, NHMRC (Australia)
Study First Received: September 26, 2008
Last Updated: April 29, 2011
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by The University of New South Wales:
Depression
Treatment
Transcranial direct current stimulation

Additional relevant MeSH terms:
Bipolar Disorder
Depression
Depressive Disorder
Depressive Disorder, Major
Disease
Affective Disorders, Psychotic
Behavioral Symptoms
Mental Disorders
Mood Disorders
Pathologic Processes

ClinicalTrials.gov processed this record on November 20, 2014