Treatment Resistant DepressionMAOINCT03109717
Structural and Functional Connectivity of Brainstem Monoamine Pathways in Treatment Resistant Depression
An observational study of Treatment Resistant Depression, run by Kathryn O'Connor at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Treatment Resistant Depression
- What is being tested?
- Monoamine Oxidase Inhibitor (MAOI)
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2016to May 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Treatment Resistant Depression and Healthy Controls
Who may be able to join
- age: 18 - 65 yrs.;
- satisfy criteria for DSM-IV major depressive disorder (MDD);
- 17-item Hamilton Depression Rating Scale (17-item HDRS) score > 18;
- 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);
- able to give informed consent;
- no use of alcohol in the past 1 week and negative urine toxicology screen;
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- MAOI treatment indicated as assessed by an independent psychiatrist not affiliated with the study;
- voluntary consent to treatment with an MAOI after reviewing all other options and agree to follow safeguards and precautions during treatment.
- ages 18-65 years and ability to give voluntary informed consent;
- no history of psychiatric illness or substance abuse or dependence;
- no significant family history of psychiatric or neurological illness;
- not currently taking any prescription or centrally acting medications; no use of alcohol in the past 1 week;
- and no serious medical or neurological illness.
Who cannot join
- schizophrenia, schizoaffective or primary anxiety disorder;
- serious medical or neurological illness;
- history of significant head injury;
- on fluoxetine treatment;
- on lithium or have received ECT or rTMS in the last 3 months to avoid long-term effects of such medications;
- substance or alcohol dependence in the past 6 months or substance abuse in the past 3 months;
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- unable to give informed consent.
- pregnant or breast-feeding;
- metallic implants or other contraindication to MRI.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- Monoamine Oxidase Inhibitor (MAOI)
- Keywords
- Treatment Resistant Depression
- Medical subject headings
- Depressive Disorder, Treatment-Resistant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Monoamine Oxidase Inhibitor (MAOI)Drug
Also called Monoamine Oxidase Inhibitor
Monoamine Oxidase Inhibitor
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Monoamine Oxidase Inhibitor (MAOI) | |
| Healthy Control | Screen for eligibility, then MRI. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brainstem Structural Connectivity (Sc)
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.
Measured: 2 years
Brainstem Functional Connectivity (Fc)
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2017
- Study startJul 2016
- Primary completionNov 2020
- Study completionMay 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Treatment Resistant DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kathryn O'Connor
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kathryn O'Connor, The Cleveland Clinic
- Investigators
- Amit Anand, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03109717
- Sponsor's protocol ID
- 15-1372
- Acronym
- MAOI
- Status last verified
- Jun 2021
- First submitted
- 1 Mar 2017
- Last updated
- 18 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Structural and Functional Connectivity of Brainstem Monoamine Pathways in Treatment Resistant Depression
- ClinicalTrials.gov ID
- NCT03109717
- Acronym / sponsor ID
- MAOI / 15-1372
- Conditions
- Treatment Resistant Depression
- Keywords
- Treatment Resistant Depression
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Kathryn O'ConnorUniversity, hospital or other
- Study start
- Jul 2016 (actual)
- Primary completion
- Nov 2020 (actual)
- Study completion
- May 2021 (actual)
- First posted
- 12 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Resistant Depression | – | Drug: Monoamine Oxidase Inhibitor (MAOI)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. |
| Healthy Control | – | –Screen for eligibility, then MRI. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Treatment Resistant Depression and Healthy Controls
Key inclusion criteria (13 listed)
- age: 18 - 65 yrs.;
- satisfy criteria for DSM-IV major depressive disorder (MDD);
- 17-item Hamilton Depression Rating Scale (17-item HDRS) score > 18;
- 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);
- able to give informed consent;
Key exclusion criteria (9 listed)
- schizophrenia, schizoaffective or primary anxiety disorder;
- serious medical or neurological illness;
- history of significant head injury;
- on fluoxetine treatment;
- on lithium or have received ECT or rTMS in the last 3 months to avoid long-term effects of such medications;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Monoamine Oxidase Inhibitor (MAOI)Also: Monoamine Oxidase InhibitorMonoamine Oxidase Inhibitor | Drug | Treatment Resistant Depression |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amit Anand, MD principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Treatment Resistant Depression, run by Kathryn O'Connor at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brainstem Structural Connectivity (Sc) (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2021.