DepressionPhase 1/2NCT00256438
Depression and Transcranial Direct Current Stimulation (tDCS)
A Phase 1/2 study testing Transcranial Direct Current Stimulation in people with Depression, run by The University of New South Wales at 1 site in Australia.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depression
- What is being tested?
- Transcranial Direct Current Stimulation
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteAustralia
- Study dates
- Feb 2006to not given
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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- On antipsychotic, anticonvulsant or benzodiazepine medication which cannot be withdrawn.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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Australia1 site, 1 recruiting
- Recruiting
Black Dog Institute Building, School of Psychiatry, University of NSW
Sydney, New South Wales, 2031
Melissa Pigot, BSc, 02 9382 3720, m.pigot@unsw.edu.au
About this study
Official title: The Treatment of Depression Using Transcranial Direct Current Stimulation (tDCS): a Pilot Study.
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.
Read the 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
- Being tested
- Transcranial Direct Current Stimulation
- Keywords
- Depression, Transcranial Direct Current Stimulation
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2005 (estimated)
- Study startFeb 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 20 participants
Sponsor and investigators
- Lead sponsor
- The University of New South Wales
- Sponsor type
- University, hospital or other
- Investigators
- Perminder P Sachdev, FRANZCP PhD, Principal investigator, University of NSWColleen K Loo, FRANZCP, MD, Principal investigator, University of NSW
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00256438
- Sponsor's protocol ID
- 05125
- Status last verified
- Jul 2006
- First submitted
- 17 Nov 2005
- Last updated
- 10 Jul 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Treatment of Depression Using Transcranial Direct Current Stimulation (tDCS): a Pilot Study.
- ClinicalTrials.gov ID
- NCT00256438
- Acronym / sponsor ID
- 05125
- Conditions
- Depression
- Keywords
- Depression, Transcranial Direct Current Stimulation
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants
- Lead sponsor
- The University of New South WalesUniversity, hospital or other
- Study start
- Feb 2006
- First posted
- 21 Nov 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial Direct Current Stimulation | Device | – |
Primary outcome
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
5 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2006.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Perminder P Sachdev, FRANZCP PhD principal investigator
University of NSW
Colleen K Loo, FRANZCP, MD principal investigator
University of NSW
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Transcranial Direct Current Stimulation in people with Depression, run by The University of New South Wales at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jul 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Colleen K Loo, FRANZCP, MD (02 9382 3721, colleen.loo@unsw.edu.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All measures at baseline and after each 5 treatments:. The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2006.