Clinical trial NCT03109717: Structural and Functional Connectivity of Brainstem Monoamine Pathways in Treatment Resistant Depression
Official title: Structural and Functional Connectivity of Brainstem Monoamine Pathways in Treatment Resistant Depression
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Treatment Resistant Depression
Keywords: Treatment Resistant Depression
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2017-04-12
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Treatment Resistant Depression and Healthy Controls

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.

Eligibility 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.

Primary outcomes:
measure: Brainstem Structural Connectivity (Sc)
timeFrame: 2 years
measure: Brainstem Functional Connectivity (Fc)
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
measure: 17-item Hamilton Depression Rating Scale
timeFrame: 2 years
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Amit Anand, MD
role: PRINCIPAL_INVESTIGATOR
References: