Major DepressionHAT-DCSNCT02894736
Home-Administered Trial of Direct Current Stimulation
A study testing Soterix tDCS machine in people with Major Depression, run by The University of New South Wales at 1 site in Australia.
Trial summary
Transcranial Direct Current Stimulation (tDCS) is a novel non-invasive brain stimulation treatment that is effective with no significant side effects. It can potentially be self-administered by patients in their own homes with remote monitoring, substantially reducing treatment costs and increasing accessibility… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Major Depression
- What is being tested?
- Soterix tDCS machine
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteAustralia
- Study dates
- Mar 2016to Jul 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
- Subject meets criteria for a DSM-IV Major Depressive Episode, lasting more than 4 weeks
- Total MADRS score ≥ 20
Who cannot join
- Diagnosis of any DSM-IV psychotic disorder
- History of drug or alcohol abuse or dependence in the preceding 3 months
- High suicide risk
- Clinically defined neurological disorder or insult
- Metal in the cranium or skull defects
- Skin lesions on the scalp (e.g. cuts, abrasions, rashes) at the proposed electrode sites
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Home-administered Transcranial Direct Current Stimulation (tDCS) Treatment for Depression
Transcranial Direct Current Stimulation (tDCS) is a novel non-invasive brain stimulation treatment that is effective with no significant side effects. It can potentially be self-administered by patients in their own homes with remote monitoring, substantially reducing treatment costs and increasing accessibility, including to remote areas. This study will evaluate the feasibility and efficacy of home-administered tDCS treatment for depression.
- Conditions
- Major Depression
- Being tested
- Soterix tDCS machine
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Soterix tDCS machineDevice
Soterix tDCS machine - miniCT supervised neuromodulation system
| Study group | Role | What they receive |
|---|---|---|
| Active tDCS | Experimental | Soterix tDCS machine is used to administer active stimulation Receives: Device: Soterix tDCS machine |
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: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2016 (estimated)
- Study startMar 2016
- Primary completionMar 2018
- Study completionJul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 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
- Angelo Alonzo, BSc(Hons)/BA, PhD, Principal investigator, University of New South Wales / Black Dog Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02894736
- Sponsor's protocol ID
- HC15010
- Acronym
- HAT-DCS
- Status last verified
- Aug 2018
- First submitted
- 5 Sep 2016
- Last updated
- 2 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home-administered Transcranial Direct Current Stimulation (tDCS) Treatment for Depression
- ClinicalTrials.gov ID
- NCT02894736
- Acronym / sponsor ID
- HAT-DCS / HC15010
- Conditions
- Major Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- The University of New South WalesUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Mar 2018 (actual)
- Study completion
- Jul 2018 (actual)
- First posted
- 9 Sep 2016 (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 novel non-invasive brain stimulation treatment that is effective with no significant side effects. It can potentially be self-administered by patients in their own homes with remote monitoring, substantially reducing treatment costs and increasing accessibility, including to remote areas. This study will evaluate the feasibility and efficacy of home-administered tDCS treatment for depression.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Active tDCS | Experimental | Device: Soterix tDCS machineSoterix tDCS machine is used to administer active 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)
- Subject meets criteria for a DSM-IV Major Depressive Episode, lasting more than 4 weeks
- Total MADRS score ≥ 20
Key exclusion criteria (7 listed)
- Diagnosis of any DSM-IV psychotic disorder
- History of drug or alcohol abuse or dependence in the preceding 3 months
- High suicide risk
- Clinically defined neurological disorder or insult
- Metal in the cranium or skull defects
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 |
|---|---|---|
| Soterix tDCS machineSoterix tDCS machine - miniCT supervised neuromodulation system | Device | Active tDCS |
Primary outcome
Montgomery Asberg Depression Rating Scale for Depression (MADRS)
Time frame: 6 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 2 Aug 2018.
Related trials for Major Depression
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
RecruitingPhase 4
Biomarker-Guided Antidepressant Selection
Depression - Major Depressive Disorder, Treatment-resistant Depression (TRD)
Recruiting
Targeting Network Dysfunction in Apathy of Late-life Depression Using Digital Therapeutics
Major Depressive Disorder, Apathy
RecruitingObservational study
Student Precarity and Psychiatry
Depressive Disorder, Major, Generalized Anxiety Disorder
Not yet recruiting
Acute Intermittent Hypoxia Therapy for Depression
Major Depressive Disorder (MDD)
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.
Angelo Alonzo, BSc(Hons)/BA, PhD principal investigator
University of New South Wales / Black Dog Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Soterix tDCS machine in people with Major 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 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 2 Aug 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: 6 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 2 Aug 2018.