Major Depressive DisorderNCT01890356
Maintenance Transcranial Electrical Stimulation for Depression
A study testing Transcranial electrical stimulation in people with Major Depressive Disorder and Bipolar Disorder, run by The University of New South Wales at 1 site in Australia.
Trial summary
Transcranial electrical stimulation (TES) techniques offer a novel treatment approach for depression and have shown promising efficacy. However, there is no published data to date on their effectiveness as a maintenance treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Major Depressive Disorder, Bipolar Disorder
- What is being tested?
- Transcranial electrical stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteAustralia
- Study dates
- Jun 2013to Feb 2018
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All participants will be ≥ 18 years old.
- Participants must have experienced a significant clinical response, defined as ≥ 50% decrease from baseline scores on the Montgomery Asberg Depression Rating Scale (MADRS).
Who cannot join
- Inadequate response to acute trial of TES.
- Suicidality.
- Clinically defined neurological disorder or insult.
- Metal in the cranium, skull defects, or skin lesions on scalp (cuts, abrasions, rash) at proposed electrode sites.
- Pregnancy (women of childbearing age will be asked to undergo a urine pregnancy test prior to starting the study).
- Concurrent long acting benzodiazepines, ritalin or dexamphetamine medication.
- Treatment for depression is changed during months 3-9 of the trial.
Trial locations and contacts
1 site in 1 country.
Australia1 site
Black Dog Institute / University of New South Wales
Randwick, Sydney, New South Wales, 2031
About this study
Official title: A Study of Transcranial Electrical Stimulation (TES) as a Maintenance Treatment for Depression
Transcranial electrical stimulation (TES) techniques offer a novel treatment approach for depression and have shown promising efficacy. However, there is no published data to date on their effectiveness as a maintenance treatment. This study will investigate ways of using TES as a maintenance treatment to prevent relapse in depression.
- Conditions
- Major Depressive Disorder, Bipolar Disorder
- Being tested
- Transcranial electrical stimulation
- Keywords
- Depression, Treatment, Transcranial electrical stimulation, Maintenance
- Medical subject headings
- Depressive Disorder, Major, Bipolar Disorder, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial electrical stimulationDevice
| Study group | Role | What they receive |
|---|---|---|
| Transcranial electrical stimulation | Experimental | Not described Receives: Device: Transcranial electrical stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Montgomery Asberg Depression Rating Scale for Depression (MADRS)
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2013 (estimated)
- Study startJun 2013
- Primary completionFeb 2018
- Study completionFeb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of New South Wales
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Colleen Loo, The University of New South Wales
- Investigators
- Colleen Loo, MBBS, Principal investigator, University of New South Wales
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01890356
- Sponsor's protocol ID
- HC12499
- Status last verified
- Mar 2018
- First submitted
- 26 Jun 2013
- Last updated
- 27 Mar 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Transcranial Electrical Stimulation (TES) as a Maintenance Treatment for Depression
- ClinicalTrials.gov ID
- NCT01890356
- Acronym / sponsor ID
- HC12499
- Conditions
- Major Depressive Disorder, Bipolar Disorder
- Keywords
- Depression, Treatment, Transcranial electrical stimulation, Maintenance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- The University of New South WalesUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Feb 2018 (actual)
- Study completion
- Feb 2018 (actual)
- First posted
- 1 Jul 2013 (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 electrical stimulation (TES) techniques offer a novel treatment approach for depression and have shown promising efficacy. However, there is no published data to date on their effectiveness as a maintenance treatment. This study will investigate ways of using TES as a maintenance treatment to prevent relapse in depression.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Transcranial electrical stimulation | Experimental | Device: Transcranial electrical stimulation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All participants will be ≥ 18 years old.
- Participants must have experienced a significant clinical response, defined as ≥ 50% decrease from baseline scores on the Montgomery Asberg Depression Rating Scale (MADRS).
Key exclusion criteria (7 listed)
- Inadequate response to acute trial of TES.
- Suicidality.
- Clinically defined neurological disorder or insult.
- Metal in the cranium, skull defects, or skin lesions on scalp (cuts, abrasions, rash) at proposed electrode sites.
- Pregnancy (women of childbearing age will be asked to undergo a urine pregnancy test prior to starting the study).
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 electrical stimulation | Device | Transcranial electrical stimulation |
Primary outcome
Montgomery Asberg Depression Rating Scale for Depression (MADRS)
Time frame: 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2018.
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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.
Colleen Loo, MBBS principal investigator
University of New South Wales
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial electrical stimulation in people with Major Depressive Disorder and Bipolar Disorder, 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 2 inclusion and 7 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: finished, as of the sponsor's last update on 27 Mar 2018. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Montgomery Asberg Depression Rating Scale for Depression (MADRS) (time frame: 9 months). 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 27 Mar 2018.