Brain MRI (Magnetic Resonance Imaging) Scans of Patients With Treatment Resistant Depression (TRD) and Healthy Controls

NCT01162434 | Completed

• 2 other identifiers: UoB111210/H0102/15
• Study Type: observational
• Target: 21
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Mental Disorders

Keywords

Treatment resistant depression; Deep brain stimulation; Brain volumetric analysis

Outcome Measures

Primary Outcomes (3)

• 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.

  6 months

• Whole brain analysis

  Whole brain MRI volumetric comparison between TRD patients undergoing DBS and healthy volunteers.

  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.

  6 months

Study Arms (2)

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.

Eligibility Criteria

• Age: 26 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• Up to 12 females and 4 males, sex, handedness and age (±5 years) matched for the DBS patients.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Bristol: lead
• North Bristol NHS Trust: collaborator

Study Sites (1)

Bristol Royal Infirmary

Bristol, BS2 8HW, United Kingdom

Location

MeSH Terms

Conditions

Mental Disorders; Depressive Disorder, Treatment-Resistant

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders

Study Officials

• Andrea Malizia, MD

  University of Bristol

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 13, 2010
• First Posted: July 14, 2010
• Study Start: February 1, 2010
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: July 12, 2012

Record last verified: 2011-08

Locations

GB (1)