Clinical Trial: Structural and Functional Connectivity of Brainstem Monoamine Pathways in Treatment Resistant Depression

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: Structural and Functional Connectivity of Brainstem Monoamine Pathways in Treatment Resistant Depression

Brief Summary: Study TRD subjects' resistance to at least 2 different antidepressants, we hypothesize that because of their significant depression and treatment resistant status they are most likely to exhibit BSMN pathway abnormalities.

Detailed Summary: Potential subjects will be identified during clinical visits. If a patient qualifies to participate in the study they will have to stop any antidepressants that they are taking to prepare for the use of MAOIs. After a two week washout period, subjects will have an fMRI and will be started on a MAOI. They will then be followed up for 8 weeks, which is routine and considered standard care.
Sponsor: Amit Anand, MD

Current Primary Outcome:

  • Brainstem Structural Connectivity (Sc) [ Time Frame: 2 years ]
    Localize BSMN and measure pathway Sc using diffusion imaging to differentiate between TRD and HC. BSMN can be localized using diffusion imaging, and pathways projecting from BSMN to known targets can be identified. Methods have been developed to localize these nuclei via a combination of diffusion imaging and anatomic imaging. We will identify these nuclei and track their projections to known targets, giving rise to the VTA-NAcc, VTA-AMYG, RN-AM and RN-sgACC pathways. Probabilistic fiber tracking between these nodes will be used to determine a measure of pathway strength.
  • Brainstem Functional Connectivity (Fc) [ Time Frame: 2 years ]
    Measure BSMN pathway Fc to differentiate between TRD and HC. BSMN associated with different neuromodulators, e.g. the VTA and RN, will be associated with distinct functional networks which will be abnormal in TRD compared to HCs.


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: The Cleveland Clinic

Dates:
Date Received: March 1, 2017
Date Started: July 2016
Date Completion: February 2018
Last Updated: April 10, 2017
Last Verified: April 2017