Major Depressive DisorderESAPNCT03548545
tDCS as add-on Treatment to Cognitive-Behavior Therapy in People With MDD
A study testing tDCS in people with Major Depressive Disorder and CBT, run by University of Minho at 1 site in Portugal.
Trial summary
This is a parallel randomized, double-blinded, sham-controlled clinical trial in which a total of 72 drug-naïve MDD subjects (36 per arm) are randomized to one of two groups: Cognitive-Behavior Therapy (CBT) combined with either active or sham tDCS. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Major Depressive Disorder, CBT, Transcranial Direct Current Stimulation
- What is being tested?
- tDCS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 sitePortugal
- Study dates
- 28 Mar 2018to 31 Dec 2020
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1)Aged 18-75 years;
- 2)Unipolar, nonpsychotic MDD;
- 3)Score in the MADRS between 7 and 34(mild to moderate depression);
- 4)Low risk of suicide;
- 5)Able to sign informed consent
Who cannot join
- 1)Any contraindication to receive tDCS(such as metal in the head, implanted brain medical devices);
- 2)any significant or unstable neurologic or psychiatric disorder other than MDD;2) history of substance abuse within the past 6-months;
- 3)Any personality disorders; and
- 5)any severe life-threatening Axis III disorders or concurrent medical condition likely to worsen patient's functional status in next 6-months such as; cancer, terminal heart, kidney, or liver disease.
Trial locations and contacts
1 site in 1 country.
Portugal1 site, 1 recruiting
- Recruiting
School of Psychology, University of Minho
Braga, 4710-057
Sandra Carvalho, PhD, +351253604661, sandrarc@psi.uminho.pt
About this study
Official title: Trancranial Direct Current Stiimulation as add-on Treatment to Cognitive-Behavior Therapy in People With Major Depression
This is a parallel randomized, double-blinded, sham-controlled clinical trial in which a total of 72 drug-naïve MDD subjects (36 per arm) are randomized to one of two groups: Cognitive-Behavior Therapy (CBT) combined with either active or sham tDCS.
The primary outcome is mood improvement, as measured by the Montgomery-Asberg Depression Rating Scale (MADRS). The secondary outcome is to test whether tDCS combined with CBT can engage the proposed mechanistic target, of restoring the prefrontal imbalance and connectivity, by changes over EEG.
Read the detailed description
Major Depression Disorder (MDD) is widely recognized as a staggering global healthcare challenge, as well as a potentially lethal illness. In Portugal, 7% of the population is diagnosed with depression every year, and suicide is responsible for more than a thousand deaths annually.
The current standard care for MDD involves the use of psychotherapy, antidepressant medication, or a combination of both. However, approximately 30% of people suffering from MDD exhibit depressive symptoms despite the appropriate psychological and pharmacological treatments. One option is to combine several treatments, usually by the use of drug augmentations and/or combinations of different drugs, which often increases the risk of adverse effects. Thus, it is important to study non-pharmacological interventions targeting mechanisms not directly involved with the regulation of neurotransmitters.
Cognitive-behavioral Therapy (CBT) is a well-established, and empirically-supported non-pharmacological treatment for depression, including for those that have not responded to antidepressants. However, several patients remain refractory to CBT.
tDCS is a safe, non-invasive, rather inexpensive, easy to administrate, and well-tolerated neuromodulatory technique. Several studies, including studies from our group, already shown that tDCS can be effective in MDD. However, tDCS seems to have a better effect when used as an add-on treatment to other intervention.
What is not known so far are the effects of using tDCS as add-on intervention to CBT on MDD symptoms.
Therefore, this is a parallel randomized, double-blinded, sham-controlled clinical trial in which a total of 72 first-episode MDD subjects (36 per arm) will be randomized to one of two groups: CBT combined with either active or sham tDCS. The design and the tDCS parameters will be similar to the SELECT trial by Brunoni et al. (2013).
The primary outcome is mood improvement, as measured by the Montgomery-Asberg Depression Rating Scale (MADRS). The secondary outcome is to test whether tDCS combined with CBT can engage the proposed mechanistic target, of restoring the prefrontal imbalance and connectivity, by changes over resting-state EEG and fMRI.
- Being tested
- tDCS
- Keywords
- MDD, CBT, tDCS
- 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.
tDCSDevice
Also called CBT
subjects will receive a total of 8-structured CBT sessions administered by a certified therapist(according to the NICE guidelines).In the first two weeks, participants will undergo 6-sessions of CBT every other day(3 CBT sessions per week) and 10 daily sessions of either active or sham tDCS(2 mA, 30 minutes).They will undergo additional booster sessions of the same intervention(active or sham tDCS followed by CBT) by week 4 and 6.
| Study group | Role | What they receive |
|---|---|---|
| CBT combined with active tDCS | Experimental | Subjects allocated to this arm will receive cognitive-behavior therapy combined with active tDCS over the dorsolateral prefrontal cortex. Receives: Device: tDCS |
| CBT combined with sham tDCS | Sham comparator | Subjects allocated to this arm will receive cognitive-behavior therapy combined with sham tDCS over the dorsolateral prefrontal cortex. Receives: Device: tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mood improvement
Mood as assessed by the Montgomery-Asberg Depression Rating Scale(MADRS)
Measured: Improvement defined as 50% decrease in the MADRS score at 4-week intervention. Cut-off points include: 0 to 6 - symptom absent, 7 to 19 - mild depression, 30 to 34 - moderate, 35 to 60 - severe depression.
Secondary outcomes (1)
EEG activity
EEG alpha activity over the prefrontal cortex
Measured: Reduction of the inter-hemispheric imbalance over DLPFC at 4-week post-intervention sessions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2018
- Study start28 Mar 2018
- Primary completion31 Dec 2019 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a parallel randomized, double blinded, sham controlled clinical trial in which a total of 72 MDD subjects(36 per arm) will be randomized to one of two groups: CBT combined with either active or sham tDCS.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Minho
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação para a Ciência e a Tecnologia
- Responsible party
- Principal investigator, Sandra Carvalho, University of Minho
- Investigators
- Sandra R Carvalho, PhD, Principal investigator, Cipsi, School of Psychology, University of Minho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03548545
- Sponsor's protocol ID
- SECVS 174/2017
- Acronym
- ESAP
- Status last verified
- Jun 2018
- First submitted
- 28 Mar 2018
- Last updated
- 15 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Carvalho S, Goncalves OF, Brunoni AR, Fernandes-Goncalves A, Fregni F, Leite J. Transcranial Direct Current Stimulation as an Add-on Treatment to Cognitive-Behavior Therapy in First Episode Drug-Naive Major Depression Patients: The ESAP Study Protocol. Front Psychiatry. 2020 Nov 3;11:563058. doi: 10.3389/fpsyt.2020.563058. eCollection 2020.
PubMed 33240121
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trancranial Direct Current Stiimulation as add-on Treatment to Cognitive-Behavior Therapy in People With Major Depression
- ClinicalTrials.gov ID
- NCT03548545
- Acronym / sponsor ID
- ESAP / SECVS 174/2017
- Keywords
- MDD, CBT, tDCS
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- University of MinhoUniversity, hospital or other
- Collaborators
- Fundação para a Ciência e a Tecnologia
- Study start
- 28 Mar 2018 (actual)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 7 Jun 2018 (actual)
- 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.
This is a parallel randomized, double-blinded, sham-controlled clinical trial in which a total of 72 drug-naïve MDD subjects (36 per arm) are randomized to one of two groups: Cognitive-Behavior Therapy (CBT) combined with either active or sham tDCS.
The primary outcome is mood improvement, as measured by the Montgomery-Asberg Depression Rating Scale (MADRS). The secondary outcome is to test whether tDCS combined with CBT can engage the proposed mechanistic target, of restoring the prefrontal imbalance and connectivity, by changes over EEG.
Detailed description
Major Depression Disorder (MDD) is widely recognized as a staggering global healthcare challenge, as well as a potentially lethal illness. In Portugal, 7% of the population is diagnosed with depression every year, and suicide is responsible for more than a thousand deaths annually.
The current standard care for MDD involves the use of psychotherapy, antidepressant medication, or a combination of both. However, approximately 30% of people suffering from MDD exhibit depressive symptoms despite the appropriate psychological and pharmacological treatments. One option is to combine several treatments, usually by the use of drug augmentations and/or combinations of different drugs, which often increases the risk of adverse effects. Thus, it is important to study non-pharmacological interventions targeting mechanisms not directly involved with the regulation of neurotransmitters.
Cognitive-behavioral Therapy (CBT) is a well-established, and empirically-supported non-pharmacological treatment for depression, including for those that have not responded to antidepressants. However, several patients remain refractory to CBT.
tDCS is a safe, non-invasive, rather inexpensive, easy to administrate, and well-tolerated neuromodulatory technique. Several studies, including studies from our group, already shown that tDCS can be effective in MDD. However, tDCS seems to have a better effect when used as an add-on treatment to other intervention.
What is not known so far are the effects of using tDCS as add-on intervention to CBT on MDD symptoms.
Therefore, this is a parallel randomized, double-blinded, sham-controlled clinical trial in which a total of 72 first-episode MDD subjects (36 per arm) will be randomized to one of two groups: CBT combined with either active or sham tDCS. The design and the tDCS parameters will be similar to the SELECT trial by Brunoni et al. (2013).
The primary outcome is mood improvement, as measured by the Montgomery-Asberg Depression Rating Scale (MADRS). The secondary outcome is to test whether tDCS combined with CBT can engage the proposed mechanistic target, of restoring the prefrontal imbalance and connectivity, by changes over resting-state EEG and fMRI.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a parallel randomized, double blinded, sham controlled clinical trial in which a total of 72 MDD subjects(36 per arm) will be randomized to one of two groups: CBT combined with either active or sham tDCS.
| Arm | Type | Receives |
|---|---|---|
| CBT combined with active tDCS | Experimental | Device: tDCSSubjects allocated to this arm will receive cognitive-behavior therapy combined with active tDCS over the dorsolateral prefrontal cortex. |
| CBT combined with sham tDCS | Sham comparator | Device: tDCSSubjects allocated to this arm will receive cognitive-behavior therapy combined with sham tDCS over the dorsolateral prefrontal cortex. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 1)Aged 18-75 years;
- 2)Unipolar, nonpsychotic MDD;
- 3)Score in the MADRS between 7 and 34(mild to moderate depression);
- 4)Low risk of suicide;
- 5)Able to sign informed consent
Key exclusion criteria (4 listed)
- 1)Any contraindication to receive tDCS(such as metal in the head, implanted brain medical devices);
- 2)any significant or unstable neurologic or psychiatric disorder other than MDD;2) history of substance abuse within the past 6-months;
- 3)Any personality disorders; and
- 5)any severe life-threatening Axis III disorders or concurrent medical condition likely to worsen patient's functional status in next 6-months such as; cancer, terminal heart, kidney, or liver disease.
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 |
|---|---|---|
| tDCSAlso: CBTsubjects will receive a total of 8-structured CBT sessions administered by a certified therapist(according to the NICE guidelines).In the first two weeks, participants will undergo 6-sessions of CBT every other day(3 CBT sessions per week) and 10 daily sessions of either active or sham tDCS(2 mA, 30 minutes).They will undergo additional booster sessions of the same intervention(active or sham tDCS followed by CBT) by week 4 and 6. | Device | CBT combined with active tDCS, CBT combined with sham tDCS |
Primary outcome
Mood improvement
Time frame: Improvement defined as 50% decrease in the MADRS score at 4-week intervention. Cut-off points include: 0 to 6 - symptom absent, 7 to 19 - mild depression, 30 to 34 - moderate, 35 to 60 - severe depression.
Mood as assessed by the Montgomery-Asberg Depression Rating Scale(MADRS)
1 secondary outcome
EEG activity
Time frame: Reduction of the inter-hemispheric imbalance over DLPFC at 4-week post-intervention sessions
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2018.
- Derived from this study: PubMed 33240121Carvalho S, Goncalves OF, Brunoni AR, Fernandes-Goncalves A, Fregni F, Leite J. Transcranial Direct Current Stimulation as an Add-on Treatment to Cognitive-Behavior Therapy in First Episode Drug-Naive Major Depression Patients: The ESAP Study Protocol. Front Psychiatry. 2020 Nov 3;11:563058. doi: 10.3389/fpsyt.2020.563058. eCollection 2020.
- Individual participant dataSharing planned: Undecided
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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.
Sandra R Carvalho, PhD principal investigator
Cipsi, School of Psychology, University of Minho
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tDCS in people with Major Depressive Disorder and CBT, run by University of Minho at 1 site in Portugal.
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 5 inclusion and 4 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 15 Jun 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 Portugal. 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.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mood improvement (time frame: Improvement defined as 50% decrease in the MADRS score at 4-week intervention. Cut-off points include: 0 to 6 - symptom absent, 7 to 19 - mild depression, 30 to 34 - moderate, 35 to 60 - severe depression.). 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 NCT03548545, which also lists 1 linked publication.
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 15 Jun 2018; AzTrials last refreshed its copy on 6 Nov 2026.