Mood DisordersAuRANCT04298944
Association of Mood With Risk for Atherosclerosis
An observational study of Mood Disorders and Hypertension, run by Johns Hopkins University at 1 site in United States.
Trial summary
The investigators will aim to determine the association of mood disorders (MDO) with preclinical and clinical cardiovascular (CVD) risk factors among children. The investigators will also aim to identify traditional and non traditional predictors of CVD risk among children with MDO. Read more about this study
- Who is it for?
- Ages Up to 22 years
- Conditions the study is for
- Mood Disorders, Hypertension, Overweight and Obesity
- What is being tested?
- Cardiovascular Assessments, Actigraphy and Laboratory assessments
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Mar 2020to 31 May 2022
- How long will I take part?
- 7 Days
- 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 Up to 22 years
- All sexes
- Child, Adult
Study population: Children and young adults up to 22 years of age who belong to either of the following groups: 1. overweight/obese and no history of mood disorders 2. overweight/obese with a mood disorder 3. not overweight/obese with a mood disorder
Who may be able to join
- Children Ages ≤ 22 years old
- Enrolled in the CHAMPION Trial and have agreed to be contacted for future studies or children who visit PMP clinic and have MDO and a healthy weight or participants in the Be-HealthY Cohort whose data indicate no history of MDO.
Who cannot join
- Not able to speak English
- Unable to lie supine
- Significant Arrhythmia
- If participant has used vaso-active drugs the morning of the test (tobacco, caffeine decongestants, or asthma medications).
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins School of Medicine Division of Pediatric Nephrology
Baltimore, Maryland, 21287
About this study
Official title: AuRA Study: Association of Mood With Risk for Atherosclerosis
The investigators will aim to determine the association of mood disorders (MDO) with preclinical and clinical cardiovascular (CVD) risk factors among children.
The investigators will also aim to identify traditional and non traditional predictors of CVD risk among children with MDO.
Read the detailed description
This research is being done to determine if mood disorders in children have an impact on stiffness of arteries and/or cause the arteries to not work as well and if MDOs impact blood pressure over a 24 hour period of time.The investigators also want to determine if children with mood disorders have any risk factors or blood tests that can predict how stiff arteries are or how well arteries function and if these are associated with cardiovascular disease risk. The investigators also want to determine if children with mood disorders have greater adverse childhood experiences, worse emotional regulation and poorer quality of sleep. The investigators hope that information from this study could help in earlier detection of cardiovascular disease risk in children.
- Conditions
- Mood Disorders, Hypertension, Overweight and Obesity, Vascular Stiffness, Sleep, Elevated Blood Pressure
- Being tested
- Cardiovascular Assessments, Actigraphy, Laboratory assessments, Emotional/ Behavioural assessments
- Medical subject headings
- Mood Disorders, Hypertension, Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiovascular AssessmentsDiagnostic test
Participants will undergo the following cardiovascular assessments: 24-hour blood pressure monitoring, arterial stiffness measurements, endothelial function measurements.
ActigraphyDiagnostic test
Participants will wear an actigraph device for 7 days to measure participant's activity and sleep
Laboratory assessmentsDiagnostic test
Participants will provide blood and urine samples for laboratory assessments.
Emotional/ Behavioural assessmentsBehavioural
Emotional /Behavioral well being will be determined by questionnaires: Pediatrics Adverse Childhood Experiences Questionnaire (ACEs Q), Childrens Emotion Management Scale Questionnaire (CEMS) and Behavior Assessment System for Children (BASC)
| Study group | Role | What they receive |
|---|---|---|
| BeHealthY Cohort | Children from BeHealthY cohort who are obese/overweight but do not have mood disorders are eligible for this study. The children will be given additional questionnaires to assess emotional/behavioral well being. Receives: Diagnostic Test: Cardiovascular Assessments; Diagnostic Test: Actigraphy; Diagnostic Test: Laboratory assessments; Behavioral: Emotional/ Behavioural assessments | |
| CHAMPION trial Cohort | Children who are overweight/obese and have severe mental illness, and who have agreed to be contacted for future research.
Tests will be done on all participants which includes cardiovascular assessments, actigraphy, laboratory assessments and emotional/behavioral assessments. Receives: Diagnostic Test: Cardiovascular Assessments; Diagnostic Test: Actigraphy; Diagnostic Test: Laboratory assessments; Behavioral: Emotional/ Behavioural assessments | |
| Pediatric Medical Psychiatric (PMP) Clinic Cohort | Children from the PMP Clinic who have severe mental illness but healthy weight. Tests will be done on all participants which includes cardiovascular assessments, actigraphy, laboratory assessments and emotional/behavioral assessments. Receives: Diagnostic Test: Cardiovascular Assessments; Diagnostic Test: Actigraphy; Diagnostic Test: Laboratory assessments; Behavioral: Emotional/ Behavioural assessments |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arterial stiffness as assessed by Pulse wave velocity
This will be determined from Pulse wave velocity (m/sec) done at the study visit
Measured: 1 day
Arterial stiffness as assessed by Ambulatory Arterial Stiffness Index (AASI)
The Ambulatory Arterial Stiffness Index will be determined from data obtained from vascular measures and during 24-hour ambulatory blood pressure monitoring. Arterial stiffness increases as the regression slope approaches 0 and the AASI approaches 1.
Measured: 1 day
Arterial stiffness as assessed by Augmentation Index
The Augmentation Index (measured as a percentage) will be determined from a vascular assessment and data obtained during 24-hour ambulatory blood pressure monitoring. A greater Augmentation Index represents a stiffer, less compliant vessel.
Measured: 1 day
Endothelial function as assessed by Laser Doppler flow perfusion
The percent change in mean blood flow will be determined from Laser Doppler flow perfusion measurements obtained using a heating protocol.
Measured: 1 day
Mean Blood pressure (mmHg)
Mean daytime systolic blood pressure in millimeters of mercury (mmHg) will be determined from 24-hour blood pressure monitoring.
Measured: 1 day
Secondary outcomes (3)
Pediatric Adverse Childhood Events (ACEs) score
The Pediatric ACEs questionnaire contains 17 yes or no questions about stressful or traumatic life events. Greater exposure to adverse childhood experiences (ACEs) is associated with poorer physical and mental health. Some researchers have suggested that an ACEs score of greater than or equal to 3 or 4 significantly increases the risk for health problems, however, there is no widely accepted threshold for how many ACEs endorsed is clinically significant or more predictive of these problems.
Measured: 1 day
Children's Emotion Management Scale (CEMS) score
The Children's Emotional management scale is a questionnaire that consists of 33 questions (3 point Likert scale) examining youth's ability to regulate appropriately the youth's negative emotions (i.e. anger, sadness, and worry). Generally, poorer emotion regulation capabilities are associated with poorer health outcomes, with most research looking at CV outcomes in adults.
Measured: 1 day
Behavior Assessment for Children (BASC) score
The Behavior Assessment for Children is a questionnaire that consists of 189 questions (True/False and 4 point Likert scale). It is a broad behavioral screening measure commonly used in child and adolescent psychology and psychiatric settings.It has three primary scales: internalizing (e.g., depression, anxiety), externalizing (e.g., aggression, hyperactivity), and total problems (combination of internalizing and externalizing plus attention problems and withdrawal subscales). Scores between 60-69 are considered "at risk" for clinical problems and scores of 70+ are considered clinically significant presence of those symptoms. Any scores that are not in this range are considered to be within normal limits and not indicative of difficulties.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2020
- Study start11 Mar 2020
- Primary completion31 May 2022
- Study completion31 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mood DisordersStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- 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
- Cross-sectional
- Enrolment
- 37 participants (actual)
- Target duration
- 7 Days
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Tammy M Brady, M.D, PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04298944
- Sponsor's protocol ID
- IRB00226838
- Other IDs
- P50MH115842-01
- Acronym
- AuRA
- Status last verified
- Aug 2022
- First submitted
- 4 Mar 2020
- Last updated
- 23 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AuRA Study: Association of Mood With Risk for Atherosclerosis
- ClinicalTrials.gov ID
- NCT04298944
- Acronym / sponsor ID
- AuRA / IRB00226838
- Conditions
- Mood Disorders, Hypertension, Overweight and Obesity, Vascular Stiffness, Sleep, Elevated Blood Pressure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 11 Mar 2020 (actual)
- Primary completion
- 31 May 2022 (actual)
- Study completion
- 31 May 2022 (actual)
- First posted
- 6 Mar 2020 (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.
The investigators will aim to determine the association of mood disorders (MDO) with preclinical and clinical cardiovascular (CVD) risk factors among children.
The investigators will also aim to identify traditional and non traditional predictors of CVD risk among children with MDO.
Detailed description
This research is being done to determine if mood disorders in children have an impact on stiffness of arteries and/or cause the arteries to not work as well and if MDOs impact blood pressure over a 24 hour period of time.The investigators also want to determine if children with mood disorders have any risk factors or blood tests that can predict how stiff arteries are or how well arteries function and if these are associated with cardiovascular disease risk. The investigators also want to determine if children with mood disorders have greater adverse childhood experiences, worse emotional regulation and poorer quality of sleep. The investigators hope that information from this study could help in earlier detection of cardiovascular disease risk in children.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 7 Days
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| BeHealthY Cohort | – | Diagnostic Test: Cardiovascular Assessments, Diagnostic Test: Actigraphy, Diagnostic Test: Laboratory assessments, Behavioral: Emotional/ Behavioural assessmentsChildren from BeHealthY cohort who are obese/overweight but do not have mood disorders are eligible for this study. The children will be given additional questionnaires to assess emotional/behavioral well being. |
| CHAMPION trial Cohort | – | Diagnostic Test: Cardiovascular Assessments, Diagnostic Test: Actigraphy, Diagnostic Test: Laboratory assessments, Behavioral: Emotional/ Behavioural assessmentsChildren who are overweight/obese and have severe mental illness, and who have agreed to be contacted for future research. Tests will be done on all participants which includes cardiovascular assessments, actigraphy, laboratory assessments and emotional/behavioral assessments. |
| Pediatric Medical Psychiatric (PMP) Clinic Cohort | – | Diagnostic Test: Cardiovascular Assessments, Diagnostic Test: Actigraphy, Diagnostic Test: Laboratory assessments, Behavioral: Emotional/ Behavioural assessmentsChildren from the PMP Clinic who have severe mental illness but healthy weight. Tests will be done on all participants which includes cardiovascular assessments, actigraphy, laboratory assessments and emotional/behavioral assessments. |
Who may qualify
- Ages
- Up to 22 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Children and young adults up to 22 years of age who belong to either of the following groups: 1. overweight/obese and no history of mood disorders 2. overweight/obese with a mood disorder 3. not overweight/obese with a mood disorder
Key inclusion criteria (2 listed)
- Children Ages ≤ 22 years old
- Enrolled in the CHAMPION Trial and have agreed to be contacted for future studies or children who visit PMP clinic and have MDO and a healthy weight or participants in the Be-HealthY Cohort whose data indicate no history of MDO.
Key exclusion criteria (4 listed)
- Not able to speak English
- Unable to lie supine
- Significant Arrhythmia
- If participant has used vaso-active drugs the morning of the test (tobacco, caffeine decongestants, or asthma 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 |
|---|---|---|
| Cardiovascular AssessmentsParticipants will undergo the following cardiovascular assessments: 24-hour blood pressure monitoring, arterial stiffness measurements, endothelial function measurements. | Diagnostic test | BeHealthY Cohort, CHAMPION trial Cohort, Pediatric Medical Psychiatric (PMP) Clinic Cohort |
| ActigraphyParticipants will wear an actigraph device for 7 days to measure participant's activity and sleep | Diagnostic test | BeHealthY Cohort, CHAMPION trial Cohort, Pediatric Medical Psychiatric (PMP) Clinic Cohort |
| Laboratory assessmentsParticipants will provide blood and urine samples for laboratory assessments. | Diagnostic test | BeHealthY Cohort, CHAMPION trial Cohort, Pediatric Medical Psychiatric (PMP) Clinic Cohort |
| Emotional/ Behavioural assessmentsEmotional /Behavioral well being will be determined by questionnaires: Pediatrics Adverse Childhood Experiences Questionnaire (ACEs Q), Childrens Emotion Management Scale Questionnaire (CEMS) and Behavior Assessment System for Children (BASC) | Behavioural | BeHealthY Cohort, CHAMPION trial Cohort, Pediatric Medical Psychiatric (PMP) Clinic Cohort |
Primary outcome
Arterial stiffness as assessed by Pulse wave velocity
Time frame: 1 day
This will be determined from Pulse wave velocity (m/sec) done at the study visit
Arterial stiffness as assessed by Ambulatory Arterial Stiffness Index (AASI)
Time frame: 1 day
The Ambulatory Arterial Stiffness Index will be determined from data obtained from vascular measures and during 24-hour ambulatory blood pressure monitoring. Arterial stiffness increases as the regression slope approaches 0 and the AASI approaches 1.
Arterial stiffness as assessed by Augmentation Index
Time frame: 1 day
The Augmentation Index (measured as a percentage) will be determined from a vascular assessment and data obtained during 24-hour ambulatory blood pressure monitoring. A greater Augmentation Index represents a stiffer, less compliant vessel.
Endothelial function as assessed by Laser Doppler flow perfusion
Time frame: 1 day
The percent change in mean blood flow will be determined from Laser Doppler flow perfusion measurements obtained using a heating protocol.
Mean Blood pressure (mmHg)
Time frame: 1 day
Mean daytime systolic blood pressure in millimeters of mercury (mmHg) will be determined from 24-hour blood pressure monitoring.
3 secondary outcomes
Pediatric Adverse Childhood Events (ACEs) score
Time frame: 1 day
Children's Emotion Management Scale (CEMS) score
Time frame: 1 day
Behavior Assessment for Children (BASC) score
Time frame: 1 day
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 23 Aug 2022.
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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.
Tammy M Brady, M.D, PhD principal investigator
Johns Hopkins University
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 Mood Disorders and Hypertension, run by Johns Hopkins University 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 2 inclusion and 4 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 23 Aug 2022. 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?
Arterial stiffness as assessed by Pulse wave velocity (time frame: 1 day). The study lists 5 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 23 Aug 2022.