Non-invasive Brain Stimulation and Cognitive Processing in Depression
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ClinicalTrials.gov Identifier: NCT01875419 |
Recruitment Status :
Completed
First Posted : June 11, 2013
Last Update Posted : May 9, 2018
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Condition or disease | Intervention/treatment | Phase |
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Unipolar Major Depressive Disorder | Device: Transcranial direct current stimulation (tDCS) Behavioral: Cognitive Behavioural Therapy | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 30 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | Neural, Cognitive, and Clinical Effects of Prefrontal Cortex Stimulation to Enhance Psychotherapy in Depression: a Double-blind Randomized Controlled Trial |
Actual Study Start Date : | July 22, 2014 |
Actual Primary Completion Date : | March 7, 2017 |
Actual Study Completion Date : | September 20, 2017 |
Arm | Intervention/treatment |
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Experimental: Patients tDCS
A group of 30 patients will receive active tDCS stimulation once a week for 8 weeks, immediately prior to CBT.
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Device: Transcranial direct current stimulation (tDCS)
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. Other Name: NeuroConn DC-STIMULATOR PLUS, number 0061. Behavioral: Cognitive Behavioural Therapy 8 sessions of one hour (once weekly) immediately after tDCS or sham stimulation |
Sham Comparator: Patients - Sham
Another group of 30 patients will receive sham stimulation once a week during 8 weeks, immediately prior to CBT.
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Behavioral: Cognitive Behavioural Therapy
8 sessions of one hour (once weekly) immediately after tDCS or sham stimulation |
- Beck Depression Inventory (BDI) score [ Time Frame: Change from Baseline BDI score at 8 sessions ]BDI scores will constitute a self-report measure of depression symptoms over the course of the trial.
- Beck Depression Inventory (BDI) score [ Time Frame: Change from Baseline BDI score at 16 sessions or when the patient ceases CBT, whichever came first ]BDI scores will constitute a self-report measure of depression.
- Hamilton Depression Rating Scale (HAMD) [ Time Frame: Change from Baseline HAMD at 8 CBT sessions ]HAMD scores will constitute an interview scale from baseline to end of tDCS.
- Cognitive Control Performance [ Time Frame: Week 0 (Baseline), 1, 2, 3, 4, 5, 6, 7, 8, and 9 ]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.
- Functional Magnetic Resonance Imaging (fMRI) data [ Time Frame: Change from Baseline brain responses to the cognitive control task at week 9 ]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.
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Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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
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): NCT01875419
United Kingdom | |
UCL Institute of Cognitive Neuroscience | |
London, United Kingdom, WC1N 3AR |
Study Chair: | Stephen Pilling, PhD | University College, London | |
Principal Investigator: | Jonathan P Roiser, PhD | University College, London |
Responsible Party: | University College, London |
ClinicalTrials.gov Identifier: | NCT01875419 |
Other Study ID Numbers: |
13/0256 |
First Posted: | June 11, 2013 Key Record Dates |
Last Update Posted: | May 9, 2018 |
Last Verified: | May 2018 |
Depressive Disorder Depressive Disorder, Major Mood Disorders Mental Disorders |