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

Completed

• Conditions: Treatment Resistant Depression
• Interventions: Drug: Monoamine Oxidase Inhibitor (MAOI)

• Registration Number: NCT03109717
• Lead Sponsor: Kathryn O'Connor

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 Description

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.

Study Timeline

• Study Start: 2016-07
• Study First Submitted: 2017-03-01
• Study First Submitted QC: 2017-04-10
• Study First Posted: 2017-04-12
• Primary Completion: 2020-11
• Study Completion: 2021-05
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-15
• Last Update Posted: 2021-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Treatment Resistant Depression	Monoamine Oxidase Inhibitor (MAOI)	Screened for eligibility using several psychiatric assessments. If qualifies to participate in the study, will have to stop any antidepressants that they are taking to prepare for the use of Monoamine Oxidase Inhibitor(MAOI). After a two week washout period, subjects will have an fMRI and will be started on a MAOI. Then be followed for 8 weeks, part of routine care.

Primary Outcome Measures

Name	Time	Method
Brainstem Structural Connectivity (Sc)	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)	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.

Trial Locations

Locations (1)

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States