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

NCT03548545 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2018-06-15

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Fundação para a Ciência e a Tecnologia

    collaborator OTHER

  • University of Minho

    lead OTHER

Principal Investigators

  • Sandra R Carvalho, PhD · Cipsi, School of Psychology, University of Minho

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-28
Primary Completion
2019-12-31
Completion
2020-12-31

Countries

  • Portugal

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03548545 on ClinicalTrials.gov