Major Depressive DisorderPhase 2/3NCT01149213
Follow-up Study of Transcranial Direct Current Stimulation to Treat Major Depressive Disorder
A Phase 2/3 study testing transcranial direct current stimulation in people with Major Depressive Disorder, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
The investigators purpose is to follow remitted patients from their previous study using transcranial direct current stimulation (tDCS); as to verify whether this treatment prevents relapse. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- transcranial direct current stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteBrazil
- Study dates
- Jun 2010to Mar 2012
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients from previous studies (ID:USP-HU-001 and ID:USP-HU-002) who:
- received tDCS and responded.
- received tDCS + sertraline and responded.
- received sertraline or placebo and did not respond, and thereafter received tDCS during the cross-over phase and responded.
Who cannot join
- Patients from previous studies who:
- received tDCS and did not respond.
- received tDCS + sertraline and did not respond.
- received sertraline or placebo and responded.
- did not respond during the crossover phase.
- do not wish to participate in the present study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Follow-up Study on Remitted Patients With Major Depressive Disorder Using Transcranial Direct Current Stimulation
The investigators purpose is to follow remitted patients from their previous study using transcranial direct current stimulation (tDCS); as to verify whether this treatment prevents relapse.
Read the detailed description
Our first ongoing study (Efficacy Study of Transcranial Direct Current Stimulation (tDCS) to Treat Major Depressive Disorder) addresses whether tDCS is an effective treatment for depression treatment. The purpose of the present study is to determine whether tDCS is also an effective strategy for sustaining remission.
We will enroll patients who presented remission using tDCS from our previous study and offer them to tDCS every other week for three months, than once a month for another three months. We will address whether tDCS prevents relapse by assessing depression scores once a month, using a time-to-event analysis.
The importance of the present study is to determine whether tDCS is able to sustain remission during long-term follow-up of depressed patients.
- Conditions
- Major Depressive Disorder
- Being tested
- transcranial direct current stimulation
- Keywords
- Major depressive disorder, follow-up, relapse, remission, transcranial direct current stimulation
- Medical subject headings
- Depressive Disorder, Major, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcranial direct current stimulationDevice
tDCS will be applied at 2mA/30 minutes, every other week during the first three months than once a month during the next three months.
| Study group | Role | What they receive |
|---|---|---|
| Transcranial Direct Current Stimulation | Experimental | In active stimulation, the anode is placed over the left dorsolateral prefrontal cortex and the cathode is placed over the right prefrontal cortex. They are located five centimeters ventrally of the primary motor area, which are located five centimeters laterally of the central point of the scalp (which is located on the intersection of the sagittal and median curves). The device will deliver a charge of 2mA for 30 minutes.
The patient will receive tDCS every other week during the first three months, then once a month during the next three months. Receives: Device: transcranial direct current stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relapse from depression
Once a month, we will address whether the patient has relapsed.
Relapse criteria:
- 2 consecutive MADRS scores > 12 or
- any MADRS scores > 15 or
- suicidal attempt or
- severe suicidal ideation or
- psychiatric hospitalization
Measured: Week 4
Relapse from depression
Same as above.
Measured: Week 8
Relapse from depression
Same as above.
Measured: Week 12
Relapse from depression
Same as above.
Measured: Week 16
Relapse from depression
Same as above.
Measured: Week 20
Relapse from depression
Same as above.
Measured: Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2010 (estimated)
- Study startJun 2010
- Primary completionDec 2011
- Study completionMar 2012
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.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andre Brunoni, University of Sao Paulo
- Investigators
- Andre R Brunoni, MD, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01149213
- Sponsor's protocol ID
- USP-HU-003
- Status last verified
- Mar 2012
- First submitted
- 22 Jun 2010
- Last updated
- 27 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Follow-up Study on Remitted Patients With Major Depressive Disorder Using Transcranial Direct Current Stimulation
- ClinicalTrials.gov ID
- NCT01149213
- Acronym / sponsor ID
- USP-HU-003
- Conditions
- Major Depressive Disorder
- Keywords
- Major depressive disorder, follow-up, relapse, remission, transcranial direct current stimulation
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Dec 2011 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 23 Jun 2010 (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.
The investigators purpose is to follow remitted patients from their previous study using transcranial direct current stimulation (tDCS); as to verify whether this treatment prevents relapse.
Detailed description
Our first ongoing study (Efficacy Study of Transcranial Direct Current Stimulation (tDCS) to Treat Major Depressive Disorder) addresses whether tDCS is an effective treatment for depression treatment. The purpose of the present study is to determine whether tDCS is also an effective strategy for sustaining remission.
We will enroll patients who presented remission using tDCS from our previous study and offer them to tDCS every other week for three months, than once a month for another three months. We will address whether tDCS prevents relapse by assessing depression scores once a month, using a time-to-event analysis.
The importance of the present study is to determine whether tDCS is able to sustain remission during long-term follow-up of depressed patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Transcranial Direct Current Stimulation | Experimental | Device: transcranial direct current stimulationIn active stimulation, the anode is placed over the left dorsolateral prefrontal cortex and the cathode is placed over the right prefrontal cortex. They are located five centimeters ventrally of the primary motor area, which are located five centimeters laterally of the central point of the scalp (which is located on the intersection of the sagittal and median curves). The device will deliver a charge of 2mA for 30 minutes. The patient will receive tDCS every other week during the first three months, then once a month during the next three months. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- received tDCS and responded.
- received tDCS + sertraline and responded.
- received sertraline or placebo and did not respond, and thereafter received tDCS during the cross-over phase and responded.
Key exclusion criteria (6 listed)
- received tDCS and did not respond.
- received tDCS + sertraline and did not respond.
- received sertraline or placebo and responded.
- did not respond during the crossover phase.
- do not wish to participate in the present 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 direct current stimulationtDCS will be applied at 2mA/30 minutes, every other week during the first three months than once a month during the next three months. | Device | Transcranial Direct Current Stimulation |
Primary outcome
Relapse from depression
Time frame: Week 4
Once a month, we will address whether the patient has relapsed. Relapse criteria: * 2 consecutive MADRS scores > 12 or * any MADRS scores > 15 or * suicidal attempt or * severe suicidal ideation or * psychiatric hospitalization
Relapse from depression
Time frame: Week 8
Same as above.
Relapse from depression
Time frame: Week 12
Same as above.
Relapse from depression
Time frame: Week 16
Same as above.
Relapse from depression
Time frame: Week 20
Same as above.
Relapse from depression
Time frame: Week 24
Same as above.
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 2012.
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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.
Andre R Brunoni, MD principal investigator
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing transcranial direct current stimulation in people with Major Depressive Disorder, run by University of Sao Paulo at 1 site in Brazil.
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 6 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 2012. 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 Brazil. 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 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?
Relapse from depression (time frame: Week 4). 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 27 Mar 2012.