Brain MRI (Magnetic Resonance Imaging) Scans of Patients With Treatment Resistant Depression (TRD) and Healthy Controls
Condition: Mental Disorders
MeSH terms: Depression; Mental Disorders; Depressive Disorder, Treatment-Resistant
Study type: Observational

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 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.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
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.
      
Keywords: Treatment resistant depression; Deep brain stimulation; Brain volumetric analysis