Unipolar Major Depressive Disorder Clinical Trial
Official title:
Neural, Cognitive, and Clinical Effects of Prefrontal Cortex Stimulation to Enhance Psychotherapy in Depression: a Double-blind Randomized Controlled Trial
Verified date | May 2018 |
Source | University College, London |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 30 |
Est. completion date | September 20, 2017 |
Est. primary completion date | March 7, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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 - Standard exclusion criteria for MRI scanning: pregnancy, breast feeding, any immovable metal in the body, weight above 250 lbs, claustrophobia - tDCS safety criteria: skin disease or skin treatment that could potentially cause irritation with electrical stimulation |
Country | Name | City | State |
---|---|---|---|
United Kingdom | UCL Institute of Cognitive Neuroscience | London |
Lead Sponsor | Collaborator |
---|---|
University College, London |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | Cognitive Control Performance | Evolution of behavioral performance on the cognitive control task over the course of the trial, performed inside the scanner at baseline and after session 8, and during tDCS stimulation once a week for 8 weeks. | Week 0 (Baseline), 1, 2, 3, 4, 5, 6, 7, 8, and 9 | |
Secondary | Functional Magnetic Resonance Imaging (fMRI) data | Brain responses to the cognitive control task in the LDLPFC and other relevant brain region will be analysed and compared after relative to before treatment. | Change from Baseline brain responses to the cognitive control task at week 9 |