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

Sponsor
Kathryn O'Connor (Other)
Overall Status
Completed
CT.gov ID
NCT03109717
Collaborator
(none)
11
Enrollment
1
Location
58
Actual Duration (Months)
0.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Monoamine Oxidase Inhibitor (MAOI)

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 Design

Study Type:
Observational
Actual Enrollment :
11 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
Structural and Functional Connectivity of Brainstem Monoamine Pathways in Treatment Resistant Depression
Actual Study Start Date :
Jul 1, 2016
Actual Primary Completion Date :
Nov 1, 2020
Actual Study Completion Date :
May 1, 2021

Arms and Interventions

Arm Intervention/Treatment
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 Names:
  • Monoamine Oxidase Inhibitor

    		•
    Healthy Control

    Screen for eligibility, then MRI.

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    2. 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.

    Other Outcome Measures

    1. 17-item Hamilton Depression Rating Scale [2 years]

      Compare baseline and end of study Hamilton depression Rating scale and imaging correlations.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria - TRD:

    1. age: 18 - 65 yrs.;

    2. satisfy criteria for DSM-IV major depressive disorder (MDD);

    3. 17-item Hamilton Depression Rating Scale (17-item HDRS) score > 18;

    4. treatment resistance depression as defined as report of inadequate response (patient report of minimal improvement or nonresponse) despite past treatment with at least 2 different classes of antidepressants acting on the 5-HT and/or DA monoamine systems(except MAOIs) (as determined with the Antidepressant Treatment History Form (ATHF)20 with score of >3 on each of the items and verified by medical records if available);

    5. able to give informed consent;

    6. no use of alcohol in the past 1 week and negative urine toxicology screen;

    7. MAOI treatment indicated as assessed by an independent psychiatrist not affiliated with the study;

    8. voluntary consent to treatment with an MAOI after reviewing all other options and agree to follow safeguards and precautions during treatment.

    Inclusion criteria for healthy subjects

    1. ages 18-65 years and ability to give voluntary informed consent;

    2. no history of psychiatric illness or substance abuse or dependence;

    3. no significant family history of psychiatric or neurological illness;

    4. not currently taking any prescription or centrally acting medications; no use of alcohol in the past 1 week;

    5. and no serious medical or neurological illness.

    Exclusion Criteria - TRD:

    1. schizophrenia, schizoaffective or primary anxiety disorder;

    2. serious medical or neurological illness;

    3. history of significant head injury;

    4. on fluoxetine treatment;

    5. on lithium or have received ECT or rTMS in the last 3 months to avoid long-term effects of such medications;

    6. substance or alcohol dependence in the past 6 months or substance abuse in the past 3 months;

    7. unable to give informed consent.

    Exclusion criteria for both groups:

    1. pregnant or breast-feeding;

    2. metallic implants or other contraindication to MRI.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Cleveland Clinic Cleveland Ohio United States 44195

    Sponsors and Collaborators

    • Kathryn O'Connor

    Investigators

    • Principal Investigator: Amit Anand, MD, The Cleveland Clinic

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Kathryn O'Connor, Administrator, The Cleveland Clinic
    ClinicalTrials.gov Identifier:
    NCT03109717
    Other Study ID Numbers:
    • 15-1372
    First Posted:
    Apr 12, 2017
    Last Update Posted:
    Jun 18, 2021
    Last Verified:
    Jun 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Kathryn O'Connor, Administrator, The Cleveland Clinic
    Treatment Resistant Depression
    Additional relevant MeSH terms:
    Depression
    Depressive Disorder
    Depressive Disorder, Treatment-Resistant
    Monoamine Oxidase Inhibitors

    Study Results

    No Results Posted as of Jun 18, 2021