DepressionTDEPNCT02016456
TMS Treatment for Depression in the National Health Service
A study testing Theta-Burst Stimulation and High frequency stimulation in people with Depression, run by Institute of Mental Health Nottingham at 1 site in United Kingdom.
Trial summary
This research programme purports to test the effectiveness of two Transcranial Magnetic Stimulation (TMS) protocols (Repetitive high frequency protocol and Theta Burst protocol) in reducing the symptoms of depression. The study also uses Magnetic Resonance Imaging (MRI) scans to improve the localization of TMS targets. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Depression
- What is being tested?
- Theta-Burst Stimulation and High frequency stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2014to Aug 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of depressive disorder (DSM-IV)
- Diagnosis of treatment resistance (at least stage 1 as defined by Thase \& Rush, 1997 for depression)
- Female or male between 18 and 70 years
Who cannot join
- History of Bipolar disorder
- Clinically relevant neurological comorbidity such as brain neoplasm, cerebral vascular events, epilepsy, neurodegenerative disorders, prior brain surgery
- Metal objects in and around body that cannot be removed
- Pregnancy
- Cardiac pacemaker or implanted medication pump
- Major unstable medical illness
- Change in prescribed medication in the 2 weeks preceding the start of TMS trial
- Current alcohol/stimulant dependence with propensity for toxic/withdrawal seizures
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Neuromodulation Unit, Nottinghamshire Healthcare NHS Trust
Nottingham, England, NG2 7UH
About this study
Official title: An Evaluation of Transcranial Magnetic Stimulation in the National Health Service
This research programme purports to test the effectiveness of two Transcranial Magnetic Stimulation (TMS) protocols (Repetitive high frequency protocol and Theta Burst protocol) in reducing the symptoms of depression. The study also uses Magnetic Resonance Imaging (MRI) scans to improve the localization of TMS targets.
- Conditions
- Depression
- Being tested
- Theta-Burst Stimulation, High frequency stimulation
- Keywords
- Transcranial Magnetic Stimulation, Neuronavigation, Magnetic Resonance Imaging
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Theta-Burst StimulationDevice
At 80% motor threshold determined using single pulse stimuli. Depending on the hemisphere determined by connectivity analysis and neuronavigation in each individual, either continuous (left prefrontal) or intermittent (right prefrontal) train of pulses will be delivered.
High frequency stimulationDevice
Left prefrontal stimulation. 120% motor threshold with a pulse sequence of 10 Hz for 4 seconds, followed by a 26 second quiet period. Treatment will last for a total of 37.5 minutes this is a total of 3,000 pulses
| Study group | Role | What they receive |
|---|---|---|
| Theta-Burst Stimulation | Experimental | Theta-Burst protocol for transcranial magnetic stimulation on dorsolateral prefrontal cortex (exact location to be determined using neuronavigation guided by Magnetic Resonance Imaging) Receives: Device: Theta-Burst Stimulation |
| High Frequency stimulation | Active comparator | High frequency Transcranial Magnetic Stimulation using the standard protocol for depression, on left dorsolateral prefrontal cortex. Receives: Device: High frequency stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of responders defined as subjects with 50% reduction in the 17-item Hamilton Depression Scale Score
Measured: 4 weeks
Secondary outcomes (1)
Mean change in Beck Depression Inventory scores
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2013 (estimated)
- Study startOct 2014
- Primary completionAug 2017
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- 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, Outcomes assessor
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Mental Health Nottingham
- Sponsor type
- University, hospital or other
- Collaborators
- Nottinghamshire Healthcare NHS Trust
- Responsible party
- Principal investigator, Sudheer Lankappa, Institute of Mental Health Nottingham
- Investigators
- Sudheer Lankappa, MRCPsych, Principal investigator, Nottinghamshire Healthcare NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02016456
- Sponsor's protocol ID
- AMH/021213
- Acronym
- TDEP
- Status last verified
- Aug 2017
- First submitted
- 15 Dec 2013
- Last updated
- 1 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of Transcranial Magnetic Stimulation in the National Health Service
- ClinicalTrials.gov ID
- NCT02016456
- Acronym / sponsor ID
- TDEP / AMH/021213
- Conditions
- Depression
- Keywords
- Transcranial Magnetic Stimulation, Neuronavigation, Magnetic Resonance Imaging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Institute of Mental Health NottinghamUniversity, hospital or other
- Collaborators
- Nottinghamshire Healthcare NHS Trust
- Study start
- Oct 2014
- Primary completion
- Aug 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 20 Dec 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.
This research programme purports to test the effectiveness of two Transcranial Magnetic Stimulation (TMS) protocols (Repetitive high frequency protocol and Theta Burst protocol) in reducing the symptoms of depression. The study also uses Magnetic Resonance Imaging (MRI) scans to improve the localization of TMS targets.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Theta-Burst Stimulation | Experimental | Device: Theta-Burst StimulationTheta-Burst protocol for transcranial magnetic stimulation on dorsolateral prefrontal cortex (exact location to be determined using neuronavigation guided by Magnetic Resonance Imaging) |
| High Frequency stimulation | Active comparator | Device: High frequency stimulationHigh frequency Transcranial Magnetic Stimulation using the standard protocol for depression, on left dorsolateral prefrontal cortex. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of depressive disorder (DSM-IV)
- Diagnosis of treatment resistance (at least stage 1 as defined by Thase \& Rush, 1997 for depression)
- Female or male between 18 and 70 years
Key exclusion criteria (8 listed)
- History of Bipolar disorder
- Clinically relevant neurological comorbidity such as brain neoplasm, cerebral vascular events, epilepsy, neurodegenerative disorders, prior brain surgery
- Metal objects in and around body that cannot be removed
- Pregnancy
- Cardiac pacemaker or implanted medication pump
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 |
|---|---|---|
| Theta-Burst StimulationAt 80% motor threshold determined using single pulse stimuli. Depending on the hemisphere determined by connectivity analysis and neuronavigation in each individual, either continuous (left prefrontal) or intermittent (right prefrontal) train of pulses will be delivered. | Device | Theta-Burst Stimulation |
| High frequency stimulationLeft prefrontal stimulation. 120% motor threshold with a pulse sequence of 10 Hz for 4 seconds, followed by a 26 second quiet period. Treatment will last for a total of 37.5 minutes this is a total of 3,000 pulses | Device | High Frequency stimulation |
Primary outcome
Proportion of responders defined as subjects with 50% reduction in the 17-item Hamilton Depression Scale Score
Time frame: 4 weeks
1 secondary outcome
Mean change in Beck Depression Inventory scores
Time frame: 4 weeks
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 1 Sep 2017.
- Related InfoLink provided by the sponsor.
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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.
Sudheer Lankappa, MRCPsych principal investigator
Nottinghamshire Healthcare NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Theta-Burst Stimulation and High frequency stimulation in people with Depression, run by Institute of Mental Health Nottingham 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 3 inclusion and 8 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 1 Sep 2017. 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. 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?
Proportion of responders defined as subjects with 50% reduction in the 17-item Hamilton Depression Scale Score (time frame: 4 weeks). 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 1 Sep 2017.