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

NCT ID: NCT03109717

Last Updated: 2021-06-18

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 11 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-07-31
• Study Completion Date: 2021-05-31

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.

Conditions

Treatment Resistant Depression

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Monoamine Oxidase Inhibitor (MAOI)

Intervention Type: DRUG

Monoamine Oxidase Inhibitor

Healthy Control

Screen for eligibility, then MRI.

No interventions assigned to this group

Interventions

Monoamine Oxidase Inhibitor (MAOI)

Monoamine Oxidase Inhibitor

Intervention Type: DRUG

Other Intervention Names

Monoamine Oxidase Inhibitor

Eligibility Criteria

Inclusion Criteria

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.

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

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.

1. pregnant or breast-feeding;

2. metallic implants or other contraindication to MRI.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Kathryn O'Connor

OTHER

Sponsor Role: lead

Responsible Party

Kathryn O'Connor

Administrator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Amit Anand, MD

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Locations

Cleveland Clinic

Cleveland, Ohio, United States

Countries

United States

Other Identifiers

15-1372

Identifier Type: -

Identifier Source: org_study_id