Mental DisordersNCT01162434
Brain MRI (Magnetic Resonance Imaging) Scans of Patients With Treatment Resistant Depression (TRD) and Healthy Controls
An observational study of Mental Disorders, run by University of Bristol at 1 site in United Kingdom.
Trial summary
Treatment resistant depression (TRD) is a major health concern, with 10% of patients with major depressive disorder not responding to conventional treatments. The investigators propose to compare the MRI (magnetic resonance imaging) brain scans of patients with TRD, which were collected during surgical planning for… Read more about this study
- Who is it for?
- Ages 26 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Mental Disorders
- How many people
- 21 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2010to Feb 2012
- Phase
- Observational
- 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 26 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Patients who have received Deep Brain Stimulation (DBS) for Treatment Resistant Depression at Frenchay Hospital, UK., and healthy volunteers who are matched to the DBS patients, sampled from the local area.
Who may be able to join
- Up to 12 females and 4 males, sex, handedness and age (±5 years) matched for the DBS patients.
Who cannot join
- Current or past psychiatric disorder as assessed with MINI and clinical interview.
- Significant head injury.
- Standard MRI risk criteria (metallic clips or pins in body, pacemaker, aneurysm clips, pregnancy, possibility of metal in eyes including history of traumatic eye injury, shrapnel or bullet injuries).
- Inability to lie in the scanner for whatever reason (e.g. claustrophobia).
- Current acute medical illness.
- Started on new medicines in the last two months that the investigator feels may interfere with the study.
- Any medical condition that in the principle investigator's opinion is not matched in the DBS sample (e.g. epilepsy, diabetes, cardiac/hepatic/renal failure but not hypertension).
- The investigator feels that the volunteer is unsuitable for the research protocol, or unable or unwilling to comply with study procedures.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Volumetric Brain MRI (Magnetic Resonance Imaging) Comparison of Patients With Treatment Resistant Depression (TRD) Undergoing Deep Brain Stimulation (DBS) With Age, Sex and Education Matched Healthy Controls
Treatment resistant depression (TRD) is a major health concern, with 10% of patients with major depressive disorder not responding to conventional treatments. The investigators propose to compare the MRI (magnetic resonance imaging) brain scans of patients with TRD, which were collected during surgical planning for deep brain stimulation, with age, sex, handedness and education-matched healthy volunteer controls, to investigate anatomical differences, specifically the volume of certain brain structures.
Read the detailed description
All the patients treated at Frenchay Hospital, UK, with deep brain stimulation (DBS) for treatment resistant depression (TRD) will be given a Patient Information Sheet, and asked if they would like to participate in this research related to their condition. If they indicate they would like to participate, patients will be asked to sign a separate informed consent form (ICF) to give permission for their previously collected MRI scan to be used for this new research purpose. Information on handedness of the patients has not been previously collected, so patients will be given a short questionnaire to determine their handedness. The patients will not be required to perform any further tasks.
For each patient that agrees to participate in the study, two healthy matched control participants will be recruited. Participants will be recruited from an existing volunteer database and by local advertisements.
Respondents interested in participating will be given a letter of invite and a participant information sheet. They will be asked several basic questions including contact details, health status, age, sex, handedness, highest qualification achieved, and scanning requirements in order to assess their basic suitability for the study. If suitable, participants will be invited to attend a screening visit. Here, the informed consent form will be signed, then their medical history will be taken, and they will be given a MINI neuropsychiatric evaluation to assess their physical and mental status. Females who have the possibility of being pregnant will be asked to provide a urine sample to check they are not pregnant, and will be required to use adequate contraception until after their scan.
If suitable, participants will complete two computerised tests of mood. Then they will have a scan date booked at Frenchay hospital. At the scanning visit, participants will be assessed for any changes in health since their screening visit, and then will complete an MRI scan. The same scanner with the same sequences will be used for the healthy controls that were used for the patients. Two sequences will be collected: a coronal T1 FFE (fast field echo) volume acquisition and an axial high resolution T2 limited volume acquisition where 16 slices are collected with 8 above the ACPC (anterior commissure posterior commissure) plane and 8 below. These sequences match the sequences that our DBS patients have had and will allow both automated anatomical quantitative analysis (using Statistical Parametric Mapping version 5 (SPM5)) and quantitative description of other MRI signals such as white matter bright spots. Participants will receive no payment, but can have a printout of their scan if they wish.
The scans will then be analysed and compared to the patient scans.
- Conditions
- Mental Disorders
- Keywords
- Treatment resistant depression, Deep brain stimulation, Brain volumetric analysis
- Medical subject headings
- Mental Disorders, Depressive Disorder, Treatment-Resistant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients | Up to 8 patients who have received Deep Brain Stimulation for Treatment Resistant Depression at Frenchay Hospital (UK) will be recruited. | |
| Healthy volunteers | Up to 16 healthy volunteers, matched to the DBS patients on age, sex, handedness, and education, will be recruited. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Region of interest analysis
Comparison of RoI volumes of specific brain structures between patients with TRD undergoing deep brain stimulation (DBS) and healthy volunteers. Specific brain regions are: hippocampus, orbitofrontal cortex and subgenual cingulate, amygdala, dorsal anterior cingulate cortex, and dorsomedial prefrontal cortex.
Measured: 6 months
Whole brain analysis
Whole brain MRI volumetric comparison between TRD patients undergoing DBS and healthy volunteers.
Measured: 6 months
Comparison of abnormalities
Comparison of other potential abnormalities e.g. areas of hyperintensity in white matter in specific brain volumes between patients with TRD undergoing DBS and healthy volunteers.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2010 (estimated)
- Study startFeb 2010
- Primary completionFeb 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental DisordersStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bristol
- Sponsor type
- University, hospital or other
- Collaborators
- North Bristol NHS Trust
- Investigators
- Andrea Malizia, MD, Principal investigator, University of Bristol
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01162434
- Sponsor's protocol ID
- UoB1112
- Other IDs
- 10/H0102/15
- Status last verified
- Aug 2011
- First submitted
- 13 Jul 2010
- Last updated
- 12 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Volumetric Brain MRI (Magnetic Resonance Imaging) Comparison of Patients With Treatment Resistant Depression (TRD) Undergoing Deep Brain Stimulation (DBS) With Age, Sex and Education Matched Healthy Controls
- ClinicalTrials.gov ID
- NCT01162434
- Acronym / sponsor ID
- UoB1112
- Conditions
- Mental Disorders
- Keywords
- Treatment resistant depression, Deep brain stimulation, Brain volumetric analysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of BristolUniversity, hospital or other
- Collaborators
- North Bristol NHS Trust
- Study start
- Feb 2010
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 14 Jul 2010 (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.
Treatment resistant depression (TRD) is a major health concern, with 10% of patients with major depressive disorder not responding to conventional treatments. The investigators propose to compare the MRI (magnetic resonance imaging) brain scans of patients with TRD, which were collected during surgical planning for deep brain stimulation, with age, sex, handedness and education-matched healthy volunteer controls, to investigate anatomical differences, specifically the volume of certain brain structures.
Detailed description
All the patients treated at Frenchay Hospital, UK, with deep brain stimulation (DBS) for treatment resistant depression (TRD) will be given a Patient Information Sheet, and asked if they would like to participate in this research related to their condition. If they indicate they would like to participate, patients will be asked to sign a separate informed consent form (ICF) to give permission for their previously collected MRI scan to be used for this new research purpose. Information on handedness of the patients has not been previously collected, so patients will be given a short questionnaire to determine their handedness. The patients will not be required to perform any further tasks.
For each patient that agrees to participate in the study, two healthy matched control participants will be recruited. Participants will be recruited from an existing volunteer database and by local advertisements.
Respondents interested in participating will be given a letter of invite and a participant information sheet. They will be asked several basic questions including contact details, health status, age, sex, handedness, highest qualification achieved, and scanning requirements in order to assess their basic suitability for the study. If suitable, participants will be invited to attend a screening visit. Here, the informed consent form will be signed, then their medical history will be taken, and they will be given a MINI neuropsychiatric evaluation to assess their physical and mental status. Females who have the possibility of being pregnant will be asked to provide a urine sample to check they are not pregnant, and will be required to use adequate contraception until after their scan.
If suitable, participants will complete two computerised tests of mood. Then they will have a scan date booked at Frenchay hospital. At the scanning visit, participants will be assessed for any changes in health since their screening visit, and then will complete an MRI scan. The same scanner with the same sequences will be used for the healthy controls that were used for the patients. Two sequences will be collected: a coronal T1 FFE (fast field echo) volume acquisition and an axial high resolution T2 limited volume acquisition where 16 slices are collected with 8 above the ACPC (anterior commissure posterior commissure) plane and 8 below. These sequences match the sequences that our DBS patients have had and will allow both automated anatomical quantitative analysis (using Statistical Parametric Mapping version 5 (SPM5)) and quantitative description of other MRI signals such as white matter bright spots. Participants will receive no payment, but can have a printout of their scan if they wish.
The scans will then be analysed and compared to the patient scans.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients | – | –Up to 8 patients who have received Deep Brain Stimulation for Treatment Resistant Depression at Frenchay Hospital (UK) will be recruited. |
| Healthy volunteers | – | –Up to 16 healthy volunteers, matched to the DBS patients on age, sex, handedness, and education, will be recruited. |
Who may qualify
- Ages
- 26 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients who have received Deep Brain Stimulation (DBS) for Treatment Resistant Depression at Frenchay Hospital, UK., and healthy volunteers who are matched to the DBS patients, sampled from the local area.
Key inclusion criteria (1 listed)
- Up to 12 females and 4 males, sex, handedness and age (±5 years) matched for the DBS patients.
Key exclusion criteria (8 listed)
- Current or past psychiatric disorder as assessed with MINI and clinical interview.
- Significant head injury.
- Standard MRI risk criteria (metallic clips or pins in body, pacemaker, aneurysm clips, pregnancy, possibility of metal in eyes including history of traumatic eye injury, shrapnel or bullet injuries).
- Inability to lie in the scanner for whatever reason (e.g. claustrophobia).
- Current acute medical illness.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Region of interest analysis
Time frame: 6 months
Comparison of RoI volumes of specific brain structures between patients with TRD undergoing deep brain stimulation (DBS) and healthy volunteers. Specific brain regions are: hippocampus, orbitofrontal cortex and subgenual cingulate, amygdala, dorsal anterior cingulate cortex, and dorsomedial prefrontal cortex.
Whole brain analysis
Time frame: 6 months
Whole brain MRI volumetric comparison between TRD patients undergoing DBS and healthy volunteers.
Comparison of abnormalities
Time frame: 6 months
Comparison of other potential abnormalities e.g. areas of hyperintensity in white matter in specific brain volumes between patients with TRD undergoing DBS and healthy volunteers.
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 12 Jul 2012.
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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.
Andrea Malizia, MD principal investigator
University of Bristol
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mental Disorders, run by University of Bristol 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 1 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 12 Jul 2012. 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?
Region of interest analysis (time frame: 6 months). 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 12 Jul 2012.