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

June 13, 2018 updated by: Sandra Carvalho, University of Minho

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

72

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Portugal
      • Braga, Portugal, 4710-057
        • Recruiting
        • School of Psychology, University of Minho
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • CBT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Reduction of the inter-hemispheric imbalance over DLPFC at 4-week post-intervention sessions

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Minho

Collaborators

Fundação para a Ciência e a Tecnologia

Investigators

  • Principal Investigator: Sandra R Carvalho, PhD, Cipsi, School of Psychology, University of Minho

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 28, 2018

Primary Completion (Anticipated)

December 31, 2019

Study Completion (Anticipated)

December 31, 2020

Study Registration Dates

First Submitted

March 28, 2018

First Submitted That Met QC Criteria

June 6, 2018

First Posted (Actual)

June 7, 2018

Study Record Updates

Last Update Posted (Actual)

June 15, 2018

Last Update Submitted That Met QC Criteria

June 13, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SECVS 174/2017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Major Depressive Disorder

Clinical Trials on tDCS

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cambodia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe