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tDCS as add-on Treatment to Cognitive-Behavior Therapy in People With MDD (ESAP)

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ClinicalTrials.gov Identifier: NCT03548545
Recruitment Status : Recruiting
First Posted : June 7, 2018
Last Update Posted : June 15, 2018
Sponsor:
Collaborator:
Fundação para a Ciência e a Tecnologia
Information provided by (Responsible Party):
Sandra Carvalho, University of Minho

Brief 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.

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.


Condition or disease Intervention/treatment Phase
Major Depressive Disorder CBT Transcranial Direct Current Stimulation Device: tDCS Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Participant, Care Provider, Outcomes Assessor)
Masking Description: Both the Participant, the outcome assessor and the Psychologist providing the CBT will be blinded to the type of the stimulation that the subject is receiving. Unblinding will occur at the end of the participation in the study and subjects that received sham tDCS will have the chance to receive the active tDCS.
Primary Purpose: Treatment
Official Title: Trancranial Direct Current Stiimulation as add-on Treatment to Cognitive-Behavior Therapy in People With Major Depression
Actual Study Start Date : March 28, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: CBT combined with active tDCS
Subjects allocated to this arm will receive cognitive-behavior therapy combined with active tDCS over the dorsolateral prefrontal cortex.
Device: tDCS
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.
Other Name: CBT

Sham Comparator: CBT combined with sham tDCS
Subjects allocated to this arm will receive cognitive-behavior therapy combined with sham tDCS over the dorsolateral prefrontal cortex.
Device: tDCS
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.
Other Name: CBT




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. EEG activity [ Time Frame: Reduction of the inter-hemispheric imbalance over DLPFC at 4-week post-intervention sessions ]
    EEG alpha activity over the prefrontal cortex



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03548545


Locations
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Portugal
School of Psychology, University of Minho Recruiting
Braga, Portugal, 4710-057
Contact: Sandra Carvalho, PhD    +351253604661    sandrarc@psi.uminho.pt   
Sponsors and Collaborators
University of Minho
Fundação para a Ciência e a Tecnologia
Investigators
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Principal Investigator: Sandra R Carvalho, PhD Cipsi, School of Psychology, University of Minho

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Responsible Party: Sandra Carvalho, PhD, University of Minho
ClinicalTrials.gov Identifier: NCT03548545     History of Changes
Other Study ID Numbers: SECVS 174/2017
First Posted: June 7, 2018    Key Record Dates
Last Update Posted: June 15, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Sandra Carvalho, University of Minho:
MDD
CBT
tDCS

Additional relevant MeSH terms:
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Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms