Unipolar Major Depressive DisorderNCT01875419
Non-invasive Brain Stimulation and Cognitive Processing in Depression
A study testing Transcranial direct current stimulation (tDCS) and Cognitive Behavioural Therapy in people with Unipolar Major Depressive Disorder, run by University College, London at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Unipolar Major Depressive Disorder
- What is being tested?
- Transcranial direct current stimulation (tDCS) and Cognitive Behavioural Therapy
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 22 Jul 2014to 20 Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
UCL Institute of Cognitive Neuroscience
London, WC1N 3AR
About this study
Official title: Neural, Cognitive, and Clinical Effects of Prefrontal Cortex Stimulation to Enhance Psychotherapy in Depression: a Double-blind Randomized Controlled Trial
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.
Read the detailed description
We propose to investigate the effect of applying transcranial direct current stimulation (tDCS) over the left dorsolateral prefrontal cortex (LDLPFC) immediately prior to each of 8 sessions of cognitive behavioural therapy (CBT), a type of psychological therapy. In addition we will investigate whether tDCS effects on CBT are due to changes in cognitive control using both behavioural and neuroimaging measures.
We hypothesize that tDCS, thanks to its enduring effects, should improve the benefits of CBT, through the enhancement of cognitive control in the patient.
Null hypothesis: mood and cognitive performance will be equivalent in depressed individuals who undergo tDCS and those who undergo sham stimulation.
Experimental hypothesis: mood and cognitive performance will be improved in depressed individuals who undergo tDCS relative to those who undergo sham stimulation.
Sixty patients suffering from depression will be recruited, and a double-blind, sham-controlled, randomised design will be used. This design means that neither participants nor researchers are aware of the conditions they have been assigned to, and has been chosen to eliminate participant expectancy ("placebo") effects and researcher bias. To ensure that 30 participants are included in each group, we will use a balanced assignment algorithm at entry into the study, which will maximise statistical power. Since the results of a study of this type have never previously been reported (to our knowledge), clinical equipoise exists, mandating the use of a sham stimulation arm. Patients with depression will be randomly assigned to one of two groups: tDCS or sham stimulation. To ensure that 30 participants are included in each group, we will use a balanced assignment algorithm at entry into the study. The whole study will be spread over 16 weeks for each participant with the following time course:
- start: baseline MRI brain scan while completing a cognitive control task; measures of depressive symptoms
- weeks 1 to 8: one session per week of tDCS or sham stimulation (20 min, while completing a cognitive control task) immediately followed by CBT (1 hour); measures of depressive symptoms
- end of week 8: post-treatment MRI scan while completing a cognitive control task and measures of depressive symptoms
- week 9 to 16: up to one session per week of CBT as usual (1 hour) without stimulation
- end of week 16, or end of CBT (whichever is sooner): measures of depressive symptoms
MRI scans will have two purposes, (1) localising the area of the DLPFC for stimulation, and (2) comparing brain responses to a cognitive control task before and after treatment.
The tDCS will be delivered using neuroConn stimulators. A 1 milliamp (mA) current will be delivered for 20 minutes through damp sponges soaked in saline solution and attached to the head of the patient using a cap. One electrode will be placed on the forehead over the LDLPFC, and the other on the left shoulder blade or left cheek to record baseline electrical signal. In the sham condition, there will be a brief current change at the beginning and end of each stimulation session, in order to mimic the effect of an actual stimulation, but no current will be delivered in between.
CBT sessions will be delivered weekly, immediately after the tDCS or sham stimulation for the first 8 weeks, and provided by qualified psychological therapists as part of standard National Health Services (NHS) care.
Mood will be assessed before the start of the study (first MRI scan), each week for the 8 week stimulation phase, at the second MRI scan and after 16 weeks, using the Montgomery and Asberg Depression Rating Scale (MADRS).
Patients will perform a task to assess their cognitive control abilities during the MRI scans, as well as during each of the 8 stimulation sessions. During this task, visual stimuli will be presented to the subject, who will have to make different responses to these stimuli by pressing buttons on a response box.
- Conditions
- Unipolar Major Depressive Disorder
- Being tested
- Transcranial direct current stimulation (tDCS), Cognitive Behavioural Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial direct current stimulation (tDCS)Device
Also called NeuroConn DC-STIMULATOR PLUS, number 0061.
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.
Cognitive Behavioural TherapyBehavioural
8 sessions of one hour (once weekly) immediately after tDCS or sham stimulation
| Study group | Role | What they receive |
|---|---|---|
| Patients tDCS | Experimental | A group of 30 patients will receive active tDCS stimulation once a week for 8 weeks, immediately prior to CBT. Receives: 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. Receives: Behavioral: Cognitive Behavioural Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Beck Depression Inventory (BDI) score
BDI scores will constitute a self-report measure of depression symptoms over the course of the trial.
Measured: Change from Baseline BDI score at 8 sessions
Beck Depression Inventory (BDI) score
BDI scores will constitute a self-report measure of depression.
Measured: 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.
Measured: Change from Baseline HAMD at 8 CBT sessions
Secondary outcomes (2)
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.
Measured: Week 0 (Baseline), 1, 2, 3, 4, 5, 6, 7, 8, and 9
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.
Measured: Change from Baseline brain responses to the cognitive control task at week 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2013 (estimated)
- Study start22 Jul 2014
- Primary completion7 Mar 2017
- Study completion20 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unipolar Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephen Pilling, PhD, Study chair, University College, LondonJonathan P Roiser, PhD, Principal investigator, University College, London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01875419
- Sponsor's protocol ID
- 13/0256
- Status last verified
- May 2018
- First submitted
- 5 Jun 2013
- Last updated
- 9 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neural, Cognitive, and Clinical Effects of Prefrontal Cortex Stimulation to Enhance Psychotherapy in Depression: a Double-blind Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01875419
- Acronym / sponsor ID
- 13/0256
- Conditions
- Unipolar Major Depressive Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Study start
- 22 Jul 2014 (actual)
- Primary completion
- 7 Mar 2017 (actual)
- Study completion
- 20 Sep 2017 (actual)
- First posted
- 11 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
We propose to investigate the effect of applying transcranial direct current stimulation (tDCS) over the left dorsolateral prefrontal cortex (LDLPFC) immediately prior to each of 8 sessions of cognitive behavioural therapy (CBT), a type of psychological therapy. In addition we will investigate whether tDCS effects on CBT are due to changes in cognitive control using both behavioural and neuroimaging measures.
We hypothesize that tDCS, thanks to its enduring effects, should improve the benefits of CBT, through the enhancement of cognitive control in the patient.
Null hypothesis: mood and cognitive performance will be equivalent in depressed individuals who undergo tDCS and those who undergo sham stimulation.
Experimental hypothesis: mood and cognitive performance will be improved in depressed individuals who undergo tDCS relative to those who undergo sham stimulation.
Sixty patients suffering from depression will be recruited, and a double-blind, sham-controlled, randomised design will be used. This design means that neither participants nor researchers are aware of the conditions they have been assigned to, and has been chosen to eliminate participant expectancy ("placebo") effects and researcher bias. To ensure that 30 participants are included in each group, we will use a balanced assignment algorithm at entry into the study, which will maximise statistical power. Since the results of a study of this type have never previously been reported (to our knowledge), clinical equipoise exists, mandating the use of a sham stimulation arm. Patients with depression will be randomly assigned to one of two groups: tDCS or sham stimulation. To ensure that 30 participants are included in each group, we will use a balanced assignment algorithm at entry into the study. The whole study will be spread over 16 weeks for each participant with the following time course:
- start: baseline MRI brain scan while completing a cognitive control task; measures of depressive symptoms
- weeks 1 to 8: one session per week of tDCS or sham stimulation (20 min, while completing a cognitive control task) immediately followed by CBT (1 hour); measures of depressive symptoms
- end of week 8: post-treatment MRI scan while completing a cognitive control task and measures of depressive symptoms
- week 9 to 16: up to one session per week of CBT as usual (1 hour) without stimulation
- end of week 16, or end of CBT (whichever is sooner): measures of depressive symptoms
MRI scans will have two purposes, (1) localising the area of the DLPFC for stimulation, and (2) comparing brain responses to a cognitive control task before and after treatment.
The tDCS will be delivered using neuroConn stimulators. A 1 milliamp (mA) current will be delivered for 20 minutes through damp sponges soaked in saline solution and attached to the head of the patient using a cap. One electrode will be placed on the forehead over the LDLPFC, and the other on the left shoulder blade or left cheek to record baseline electrical signal. In the sham condition, there will be a brief current change at the beginning and end of each stimulation session, in order to mimic the effect of an actual stimulation, but no current will be delivered in between.
CBT sessions will be delivered weekly, immediately after the tDCS or sham stimulation for the first 8 weeks, and provided by qualified psychological therapists as part of standard National Health Services (NHS) care.
Mood will be assessed before the start of the study (first MRI scan), each week for the 8 week stimulation phase, at the second MRI scan and after 16 weeks, using the Montgomery and Asberg Depression Rating Scale (MADRS).
Patients will perform a task to assess their cognitive control abilities during the MRI scans, as well as during each of the 8 stimulation sessions. During this task, visual stimuli will be presented to the subject, who will have to make different responses to these stimuli by pressing buttons on a response box.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients tDCS | Experimental | Device: Transcranial direct current stimulation (tDCS), Behavioral: Cognitive Behavioural TherapyA group of 30 patients will receive active tDCS stimulation once a week for 8 weeks, immediately prior to CBT. |
| Patients - Sham | Sham comparator | Behavioral: Cognitive Behavioural TherapyAnother group of 30 patients will receive sham stimulation once a week during 8 weeks, immediately prior to CBT. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial direct current stimulation (tDCS)Also: NeuroConn DC-STIMULATOR PLUS, number 0061.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. | Device | Patients tDCS |
| Cognitive Behavioural Therapy8 sessions of one hour (once weekly) immediately after tDCS or sham stimulation | Behavioural | Patients - Sham, Patients tDCS |
Primary outcome
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.
2 secondary outcomes
Cognitive Control Performance
Time frame: Week 0 (Baseline), 1, 2, 3, 4, 5, 6, 7, 8, and 9
Functional Magnetic Resonance Imaging (fMRI) data
Time frame: Change from Baseline brain responses to the cognitive control task at week 9
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen Pilling, PhD study chair
University College, London
Jonathan P Roiser, PhD principal investigator
University College, London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial direct current stimulation (tDCS) and Cognitive Behavioural Therapy in people with Unipolar Major Depressive Disorder, run by University College, London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Beck Depression Inventory (BDI) score (time frame: Change from Baseline BDI score at 8 sessions). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2018.