Unipolar DepressionPhase 2/3NCT01562184
Investigating tDCS as a Treatment for Unipolar and Bipolar Depression
A Phase 2/3 study testing Soterix tDCS device in people with Unipolar Depression and Bipolar Depression, run by The University of New South Wales at 6 sites in 2 countries.
Trial summary
Transcranial direct current stimulation (tDCS) is a novel treatment approach for depression that has shown promising efficacy in four recent double-blind, randomized, sham-controlled trials (RCT) and a meta-analysis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Unipolar Depression, Bipolar Depression
- What is being tested?
- Soterix tDCS device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 6 sitesin 2 countries
- Study dates
- Jun 2012to Oct 2015
- Phase
- Phase 2/3
- 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
- 18 years of age or above.
- Meets criteria for a DSM-IV Major Depressive Episode with duration of at least 4 weeks.
- Total score ≥ 20 on the Montgomery-Asberg Depression Rating Scale at study entry.
Who cannot join
- Current episode duration greater than 3 years.
- Failed more than 3 adequate antidepressant trials in current episode.
- DSM-IV psychotic disorder.
- Drug or alcohol abuse or dependence (preceding 3 months).
- Inadequate response to ECT in the current episode of depression.
- Rapid clinical response required, e.g., high suicide risk.
Show all 11Show fewer
- Significant acute suicide risk, defined as follows: suicide attempt within the previous 6 months that required medical treatment; or ≥ 2 suicide attempts in the past 12 months; or has a clear-cut plan for suicide and states that they cannot guarantee that they will call their regular psychiatrist or the investigator if the impulse to implement the plan becomes substantial during the study; or in the investigator's opinion, is likely to attempt suicide within the next 6 months.
- 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.
- Concurrent long acting benzodiazepines, ritalin or dexamphetamine medication.
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
United States5 sites
Emory University
Atlanta, Georgia, 30322
Rowan University
Cherry Hill, New Jersey, 08002
University of Texas Southwestern
Dallas, Texas, 75390
Duke University
Durham, North Carolina, 27710
Sheppard Pratt
Towson, Maryland, 21285
Australia1 site
University of New South Wales / Black Dog Institute
Sydney, New South Wales, 2031
About this study
Official title: A Controlled Trial of Transcranial Direct Current Stimulation as a Treatment for Unipolar and Bipolar Depression
Transcranial direct current stimulation (tDCS) is a novel treatment approach for depression that has shown promising efficacy in four recent double-blind, randomized, sham-controlled trials (RCT) and a meta-analysis. This study is a RCT of tDCS in depressed patients, testing its efficacy in both unipolar and bipolar depression. Mood, cognitive test performance and biomarkers will be measured during the trial.
- Conditions
- Unipolar Depression, Bipolar Depression
- Being tested
- Sham tDCS device, Soterix tDCS device
- Medical subject headings
- Depressive Disorder, Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sham tDCS deviceDevice
Sham tDCS
Soterix tDCS deviceDevice
Active tDCS
| Study group | Role | What they receive |
|---|---|---|
| Active tDCS | Active comparator | Active tDCS Receives: Device: Soterix tDCS device |
| Sham tDCS | Sham comparator | Sham tDCS Receives: Device: Sham tDCS device |
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: 12 weeks
Secondary outcomes (2)
Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR)
Measured: 12 weeks
Montreal Cognitive Assessment (MoCA): Global Cognitive Function
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2012 (estimated)
- Study startJun 2012
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Unipolar 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of New South Wales
- Sponsor type
- University, hospital or other
- Collaborators
- Duke University, Emory University, Sheppard Pratt Health System, University of Medicine and Dentistry of New Jersey, University of Texas
- Responsible party
- Principal investigator, Colleen Loo, The University of New South Wales
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01562184
- Sponsor's protocol ID
- HC11515
- Other IDs
- #11T-005
- Status last verified
- Nov 2015
- First submitted
- 21 Mar 2012
- Last updated
- 2 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Martin DM, McClintock SM, Aaronson ST, Alonzo A, Husain MM, Lisanby SH, McDonald WM, Mohan A, Nikolin S, O'Reardon J, Weickert CS, Loo CK. Pre-treatment attentional processing speed and antidepressant response to transcranial direct current stimulation: Results from an international randomized controlled trial. Brain Stimul. 2018 Nov-Dec;11(6):1282-1290. doi: 10.1016/j.brs.2018.08.011. Epub 2018 Aug 23.
PubMed 30172724Loo CK, Husain MM, McDonald WM, Aaronson S, O'Reardon JP, Alonzo A, Weickert CS, Martin DM, McClintock SM, Mohan A, Lisanby SH; International Consortium of Research in tDCS (ICRT). International randomized-controlled trial of transcranial Direct Current Stimulation in depression. Brain Stimul. 2018 Jan-Feb;11(1):125-133. doi: 10.1016/j.brs.2017.10.011. Epub 2017 Oct 27.
PubMed 29111077
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Controlled Trial of Transcranial Direct Current Stimulation as a Treatment for Unipolar and Bipolar Depression
- ClinicalTrials.gov ID
- NCT01562184
- Acronym / sponsor ID
- HC11515
- Conditions
- Unipolar Depression, Bipolar Depression
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- The University of New South WalesUniversity, hospital or other
- Collaborators
- Duke University, Emory University, Sheppard Pratt Health System, University of Medicine and Dentistry of New Jersey, University of Texas
- Study start
- Jun 2012
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 23 Mar 2012 (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 treatment approach for depression that has shown promising efficacy in four recent double-blind, randomized, sham-controlled trials (RCT) and a meta-analysis. This study is a RCT of tDCS in depressed patients, testing its efficacy in both unipolar and bipolar depression. Mood, cognitive test performance and biomarkers will be measured during the trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active tDCS | Active comparator | Device: Soterix tDCS deviceActive tDCS |
| Sham tDCS | Sham comparator | Device: Sham tDCS deviceSham tDCS |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years of age or above.
- Meets criteria for a DSM-IV Major Depressive Episode with duration of at least 4 weeks.
- Total score ≥ 20 on the Montgomery-Asberg Depression Rating Scale at study entry.
Key exclusion criteria (11 listed)
- Current episode duration greater than 3 years.
- Failed more than 3 adequate antidepressant trials in current episode.
- DSM-IV psychotic disorder.
- Drug or alcohol abuse or dependence (preceding 3 months).
- Inadequate response to ECT in the current episode of depression.
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 |
|---|---|---|
| Sham tDCS deviceSham tDCS | Device | Sham tDCS |
| Soterix tDCS deviceActive tDCS | Device | Active tDCS |
Primary outcome
Montgomery Asberg Depression Rating Scale for Depression (MADRS)
Time frame: 12 weeks
2 secondary outcomes
Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR)
Time frame: 12 weeks
Montreal Cognitive Assessment (MoCA): Global Cognitive Function
Time frame: 8 weeks
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 Dec 2015.
- Derived from this study: PubMed 30172724Martin DM, McClintock SM, Aaronson ST, Alonzo A, Husain MM, Lisanby SH, McDonald WM, Mohan A, Nikolin S, O'Reardon J, Weickert CS, Loo CK. Pre-treatment attentional processing speed and antidepressant response to transcranial direct current stimulation: Results from an international randomized controlled trial. Brain Stimul. 2018 Nov-Dec;11(6):1282-1290. doi: 10.1016/j.brs.2018.08.011. Epub 2018 Aug 23.
- Derived from this study: PubMed 29111077Loo CK, Husain MM, McDonald WM, Aaronson S, O'Reardon JP, Alonzo A, Weickert CS, Martin DM, McClintock SM, Mohan A, Lisanby SH; International Consortium of Research in tDCS (ICRT). International randomized-controlled trial of transcranial Direct Current Stimulation in depression. Brain Stimul. 2018 Jan-Feb;11(1):125-133. doi: 10.1016/j.brs.2017.10.011. Epub 2017 Oct 27.
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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.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Soterix tDCS device in people with Unipolar Depression and Bipolar Depression, run by The University of New South Wales at 6 sites in 2 countries.
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 3 inclusion and 11 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 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States, 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01562184, which also lists 2 linked publications.
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 Dec 2015.