Structural and Functional Connectivity of Brainstem Monoamine Pathways in Treatment Resistant Depression (MAOI)
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|ClinicalTrials.gov Identifier: NCT03109717|
Recruitment Status : Recruiting
First Posted : April 12, 2017
Last Update Posted : April 17, 2019
|Condition or disease||Intervention/treatment|
|Treatment Resistant Depression||Drug: Monoamine Oxidase Inhibitor (MAOI)|
|Study Type :||Observational|
|Estimated Enrollment :||24 participants|
|Official Title:||Structural and Functional Connectivity of Brainstem Monoamine Pathways in Treatment Resistant Depression|
|Actual Study Start Date :||July 2016|
|Estimated Primary Completion Date :||November 2020|
|Estimated Study Completion Date :||December 2021|
Treatment Resistant Depression
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.
Drug: Monoamine Oxidase Inhibitor (MAOI)
Monoamine Oxidase Inhibitor
Other Name: Monoamine Oxidase Inhibitor
Screen for eligibility, then MRI.
- 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.
- 17-item Hamilton Depression Rating Scale [ Time Frame: 2 years ]Compare baseline and end of study Hamilton depression Rating scale and imaging correlations.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03109717
|Contact: Amit Anand, MDfirstname.lastname@example.org|
|Contact: Amy Morrison, MAemail@example.com|
|United States, Ohio|
|Cleveland, Ohio, United States, 44195|
|Contact: Amy Morrison 216-445-2378 firstname.lastname@example.org|
|Principal Investigator:||Amit Anand, MD||The Cleveland Clinic|