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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
Sponsor:
Information provided by (Responsible Party):
Amit Anand, MD, The Cleveland Clinic

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
Treatment Resistant Depression 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.

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Study Type : Observational
Estimated Enrollment : 24 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 : July 2016
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Group/Cohort 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 Name: Monoamine Oxidase Inhibitor

Healthy Control
Screen for eligibility, then MRI.



Primary Outcome Measures :
  1. 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.

  2. 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.


Other Outcome Measures:
  1. 17-item Hamilton Depression Rating Scale [ Time Frame: 2 years ]
    Compare baseline and end of study Hamilton depression Rating scale and imaging correlations.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Treatment Resistant Depression and Healthy Controls
Criteria

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.

Information from the National Library of Medicine

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


Contacts
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Contact: Amit Anand, MD 216-636-2840 ananda@ccf.org
Contact: Amy Morrison, MA 216-445-2378 morrisa15@ccf.org

Locations
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United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Amy Morrison    216-445-2378    morrisa15@ccf.org   
Sponsors and Collaborators
Amit Anand, MD
Investigators
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Principal Investigator: Amit Anand, MD The Cleveland Clinic

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Responsible Party: Amit Anand, MD, Principal Investigator, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT03109717     History of Changes
Other Study ID Numbers: 15-1372
First Posted: April 12, 2017    Key Record Dates
Last Update Posted: April 17, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Amit Anand, MD, The Cleveland Clinic:
Treatment Resistant Depression
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Depressive Disorder, Treatment-Resistant
Behavioral Symptoms
Mood Disorders
Mental Disorders
Monoamine Oxidase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action