Non-invasive Brain Stimulation and Cognitive Processing in Depression

NCT01875419 | Completed DMC

• 1 other identifier: 13/0256
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Depression is a serious mental health problem that affects millions. Depression is usually treated using drugs and/or psychotherapy, but neither approach is successful for everyone, and some people do not respond to either. Therefore it is crucial that we continue to seek new methods for treating depression, and develop enhancements to existing treatments. In recent years, trials have documented improvements in depressive symptoms using noninvasive brain stimulation techniques, such as transcranial direct current stimulation, or tDCS. Our aim in this research is to investigate the effects of brain stimulation combined with psychological therapy in depression, an area that remains largely unexplored. Specifically, stimulation of the dorsolateral prefrontal cortex (DLPFC), a brain region known to work inefficiently in depression, has been shown to result in an improvement of depressive symptoms, as well as in the patient's 'cognitive control' abilities. Because 'cognitive control' processes, such as concentrating and ignoring distracting thoughts, are engaged during psychological therapies for depression, we predict that DLPFC stimulation should improve how patients respond to psychological therapy. This study has considerable implications as it will potentially benefit a large number of patients for which current treatments are ineffective.

Conditions

Unipolar Major Depressive Disorder

Outcome Measures

Primary Outcomes (3)

• Beck Depression Inventory (BDI) score

  BDI scores will constitute a self-report measure of depression symptoms over the course of the trial.

  Change from Baseline BDI score at 8 sessions

• Beck Depression Inventory (BDI) score

  BDI scores will constitute a self-report measure of depression.

  Change from Baseline BDI score at 16 sessions or when the patient ceases CBT, whichever came first

• Hamilton Depression Rating Scale (HAMD)

  HAMD scores will constitute an interview scale from baseline to end of tDCS.

  Change from Baseline HAMD at 8 CBT sessions

Secondary Outcomes (2)

• Cognitive Control Performance

  Week 0 (Baseline), 1, 2, 3, 4, 5, 6, 7, 8, and 9

• Functional Magnetic Resonance Imaging (fMRI) data

  Change from Baseline brain responses to the cognitive control task at week 9

Study Arms (2)

Patients tDCS

EXPERIMENTAL

A group of 30 patients will receive active tDCS stimulation once a week for 8 weeks, immediately prior to CBT.

Device: Transcranial direct current stimulation (tDCS); Behavioral: Cognitive Behavioural Therapy

Patients - Sham

SHAM COMPARATOR

Another group of 30 patients will receive sham stimulation once a week during 8 weeks, immediately prior to CBT.

Behavioral: Cognitive Behavioural Therapy

Interventions

Transcranial direct current stimulation (tDCS) DEVICE

Patients - tDCS arm: 1 mA current delivered for 20 minutes once a week for 8 weeks, immediately prior to CBT. Patients - Sham arm: brief current change at the beginning (0 min) and end of each stimulation session (20 min) in order to mimic the effect of an actual stimulation, but no current delivered in between.

Also known as: NeuroConn DC-STIMULATOR PLUS, number 0061.

Patients tDCS

Cognitive Behavioural Therapy BEHAVIORAL

8 sessions of one hour (once weekly) immediately after tDCS or sham stimulation

Patients - Sham; Patients tDCS

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients suffering from unipolar major depressive disorder
• First depressive episode onset before 40 years old
• Right-handedness
• English as first language
• Intention to commence a course of cognitive behavioural therapy

You may not qualify if:

• Antidepressant or other psychotropic medication at any time during the study or within previous 4 weeks (8 for fluoxetine)
• Recent illicit drug use
• Prior mixed, manic, or psychotic symptoms or other psychiatric or neurological illness
• tDCS safety criteria: skin disease or skin treatment that could potentially cause irritation with electrical stimulation

Sponsors & Collaborators

• University College, London: lead

Study Sites (1)

UCL Institute of Cognitive Neuroscience

London, WC1N 3AR, United Kingdom

Location

MeSH Terms

Interventions

Transcranial Direct Current Stimulation; Cognitive Behavioral Therapy

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques; Behavior Therapy; Psychotherapy

Study Officials

• Stephen Pilling, PhD

  University College, London

  STUDY CHAIR

• Jonathan P Roiser, PhD

  University College, London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2013
• First Posted: June 11, 2013
• Study Start: July 22, 2014
• Primary Completion: March 7, 2017
• Study Completion: September 20, 2017
• Last Updated: May 9, 2018

Record last verified: 2018-05

Locations

GB (1)