DepressionNCT02596698
Mitochondrial Dysfunction, Inflammation, and White Matter Integrity in Youth With Mood Disorders
An observational study of Depression and Bipolar Disorder, run by University of Minnesota at 2 sites in United States.
Trial summary
This study consists of three separate appointments including a clinical assessment (interview and questionnaires), a blood draw, a social stress test, and a brain MRI. Read more about this study
- Who is it for?
- Ages 13 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression, Bipolar Disorder, Bipolar Disorder Not Otherwise Specified
- How many people
- 54 participants
- Where
- 2 sitesUnited States
- Study dates
- 31 Oct 2015to 31 Mar 2018
- 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 13 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Adolescents with mood disorders will be recruited from the University of Minnesota outpatient and inpatient clinical services, through physician referral, and through community postings. Recruitment of healthy controls will be done through flyers and online postings in the community.
Who may be able to join
- Age 13-18 years old
- Both child and guardian are English speaking
- Has a diagnosis of a depressive disorder, a bipolar spectrum disorder (type 1, type 2, Unspecified), or an unspecified mood disorder based on the Diagnostic Statsitical Manual 5 (DSM-5)
- Does not meet criteria for any psychiatric disorders based on the DSM-5
- Does not have a family history of psychotic or mood disorders in first degree relative
Who cannot join
- Past history of brain damage, a seizure disorder, increased intracranial pressure, history of head trauma with loss of consciousness for >15 minutes, history of stroke, mental retardation, or other serious neurological disorder
- MRI contraindications such as braces, metal implants, implanted medical devices, or claustrophobia
- Intelligence quotient < 80
- Severe or acute medical illness
- A history of current (past 3 months) substance disorder (defined by DSM-5) with the exception of Nicotine
- Refusal to cooperate with study procedures
- Active suicidal ideation with intent
- Self-injury that requires medical attention (e.g. stitches) or gets significantly worse during the course of the study
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Ambulatory Research Center (ARC)
Minneapolis, Minnesota, 55454
Center for Magnetic Resonance Research
Minneapolis, Minnesota, 55455
About this study
This study consists of three separate appointments including a clinical assessment (interview and questionnaires), a blood draw, a social stress test, and a brain MRI.
Read the detailed description
This is a research study looking at the biology of mood disorders in youth. The investigator ask participants to come in for three visits. The first visit includes a diagnostic interview, some questionnaires, and a blood draw. The blood draw will take place at the Fairview Outpatient Lab. A trained technician will take about 4 teaspoons of blood from the participant's arm. This sample will be sent to Dr. Andreazza in Toronto, Ontario for further analysis. No results will be shared with the participant.
The second visit would take place at the Fairview Riverside Ambulatory Research Center (ARC). This appointment will include the Trier Social Stress Test (TSST). For this, participants will be asked to prepare a short speech for 5 minutes and deliver that speech for in front of an audience with another task to follow. This task will be videotaped. After the participant has completed the speech task, the participant will be asked to complete a number of laptop games which will test for things like attention and memory. Participants will be asked to provide 5 saliva samples throughout the course of this visit so the investigators can look at Cortisol which is a hormone naturally found in saliva. The investigators will also ask participants to complete an additional set of 5 spit samples at home during the course of a normal day and bring those back to their next appointment.
The third visit would take place at the Center for Magnetic Resonance Research (CMRR) and would include a brain MRI. The MRI scan is noninvasive and takes about 2 hours. Participants will be asked to provide a urine sample and complete a urine toxicology screen (drug test) and pregnancy test (if female) prior to the MRI scan. Participants may not participate if drug or pregnancy testing is positive. The MRI involves taking pictures of the brain, from which measures of the integrity of certain brain tissues can be derived. For the scan, participants will be asked to lie down quietly on a scanner bed. Once they are inside the scanner, it will start to take pictures. While in the scanner, participants will be doing things like resting, or listening to music.
- Conditions
- Depression, Bipolar Disorder, Bipolar Disorder Not Otherwise Specified, Unspecified Mood Disorder
- Keywords
- Mood Disorder
- Medical subject headings
- Depression, Bipolar Disorder, Mood Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Adolescents with Mood Disorders | Teens aged 13-18 with a diagnosis of a mood disorder. | |
| Adolescents with no Mental Health Diagnoses | 13-18, no psychiatric d/o diagnosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Analysis
Blood samples will be analysed for mitochondrial dysfunction and resulting oxidative damage to lipids, and protein and messenger ribonucleic acid levels of inflammatory cytokines
Measured: Baseline
Secondary outcomes (4)
MRI Data
White matter integrity. Diffusion imaging data will be processed, following registration and motion correction, using a probabilistic tractography approach that will define and extract parameters such as fractional anisotrophy and radial diffusion from fiber bundles of interest. In this study we will focus on white matter tracts connecting fronto-limbic brain regions. Details about the tractography procedures can be found at http://surfer.nmr.mgh.harvard.edu/fswiki/Tracula
Measured: Up to 6 weeks after baseline
Saliva Cortisol
Stress Functioning. Saliva samples from the Trier Social Stress Test will be stored in a freezer and sent as a complete batch to Trier, Germany. We will conduct repeated measures ANOVA tests on the cortisol data and examine group and group x time interactions. We will calculate the Area Under the Curve for each person's pattern of cortisol responses over time, and these values will be used in multivariate regression analyses below.
Measured: Up to 6 weeks of baseline
Beck Depression Inventory (BDI-II)
Measures levels of depression in participants. Has information on suicidal ideation. If participants are suicidal, a member of research staff will talk with the participant and develop a safety plan with the adolescent and their parent.
Measured: Baseline and within 6 weeks of baseline
Children's Depression Rating Scale - Revised (CDRS-R)
Measures levels of depression in participants. Has information on suicidal ideation. If participants are suicidal, a member of research staff will talk with the participant and develop a safety plan with the adolescent and their parent.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2015 (estimated)
- Study start31 Oct 2015
- Primary completion31 Mar 2018
- Study completion31 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- Ontario Mental Health Foundation
- Responsible party
- Sponsor
- Investigators
- Kathryn R Cullen, MD, Principal investigator, University of MinnesotaAna Andreazza, PhD, Principal investigator, University of Toronto, OntarioBonnie Klimes-Dougan, PhD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02596698
- Sponsor's protocol ID
- 1507M75201
- Status last verified
- Jan 2020
- First submitted
- 13 Oct 2015
- Last updated
- 5 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mitochondrial Dysfunction, Inflammation, and White Matter Integrity in Youth With Mood Disorders
- ClinicalTrials.gov ID
- NCT02596698
- Acronym / sponsor ID
- 1507M75201
- Conditions
- Depression, Bipolar Disorder, Bipolar Disorder Not Otherwise Specified, Unspecified Mood Disorder
- Keywords
- Mood Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- Ontario Mental Health Foundation
- Study start
- 31 Oct 2015 (actual)
- Primary completion
- 31 Mar 2018 (actual)
- Study completion
- 31 Mar 2018 (actual)
- First posted
- 4 Nov 2015 (estimated)
- 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.
This study consists of three separate appointments including a clinical assessment (interview and questionnaires), a blood draw, a social stress test, and a brain MRI.
Detailed description
This is a research study looking at the biology of mood disorders in youth. The investigator ask participants to come in for three visits. The first visit includes a diagnostic interview, some questionnaires, and a blood draw. The blood draw will take place at the Fairview Outpatient Lab. A trained technician will take about 4 teaspoons of blood from the participant's arm. This sample will be sent to Dr. Andreazza in Toronto, Ontario for further analysis. No results will be shared with the participant.
The second visit would take place at the Fairview Riverside Ambulatory Research Center (ARC). This appointment will include the Trier Social Stress Test (TSST). For this, participants will be asked to prepare a short speech for 5 minutes and deliver that speech for in front of an audience with another task to follow. This task will be videotaped. After the participant has completed the speech task, the participant will be asked to complete a number of laptop games which will test for things like attention and memory. Participants will be asked to provide 5 saliva samples throughout the course of this visit so the investigators can look at Cortisol which is a hormone naturally found in saliva. The investigators will also ask participants to complete an additional set of 5 spit samples at home during the course of a normal day and bring those back to their next appointment.
The third visit would take place at the Center for Magnetic Resonance Research (CMRR) and would include a brain MRI. The MRI scan is noninvasive and takes about 2 hours. Participants will be asked to provide a urine sample and complete a urine toxicology screen (drug test) and pregnancy test (if female) prior to the MRI scan. Participants may not participate if drug or pregnancy testing is positive. The MRI involves taking pictures of the brain, from which measures of the integrity of certain brain tissues can be derived. For the scan, participants will be asked to lie down quietly on a scanner bed. Once they are inside the scanner, it will start to take pictures. While in the scanner, participants will be doing things like resting, or listening to music.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adolescents with Mood Disorders | – | –Teens aged 13-18 with a diagnosis of a mood disorder. |
| Adolescents with no Mental Health Diagnoses | – | –13-18, no psychiatric d/o diagnosis |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Adolescents with mood disorders will be recruited from the University of Minnesota outpatient and inpatient clinical services, through physician referral, and through community postings. Recruitment of healthy controls will be done through flyers and online postings in the community.
Key inclusion criteria (5 listed)
- Age 13-18 years old
- Both child and guardian are English speaking
- Has a diagnosis of a depressive disorder, a bipolar spectrum disorder (type 1, type 2, Unspecified), or an unspecified mood disorder based on the Diagnostic Statsitical Manual 5 (DSM-5)
- Does not meet criteria for any psychiatric disorders based on the DSM-5
- Does not have a family history of psychotic or mood disorders in first degree relative
Key exclusion criteria (8 listed)
- Past history of brain damage, a seizure disorder, increased intracranial pressure, history of head trauma with loss of consciousness for >15 minutes, history of stroke, mental retardation, or other serious neurological disorder
- MRI contraindications such as braces, metal implants, implanted medical devices, or claustrophobia
- Intelligence quotient < 80
- Severe or acute medical illness
- A history of current (past 3 months) substance disorder (defined by DSM-5) with the exception of Nicotine
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Blood Analysis
Time frame: Baseline
Blood samples will be analysed for mitochondrial dysfunction and resulting oxidative damage to lipids, and protein and messenger ribonucleic acid levels of inflammatory cytokines
4 secondary outcomes
MRI Data
Time frame: Up to 6 weeks after baseline
Saliva Cortisol
Time frame: Up to 6 weeks of baseline
Beck Depression Inventory (BDI-II)
Time frame: Baseline and within 6 weeks of baseline
Children's Depression Rating Scale - Revised (CDRS-R)
Time frame: Baseline
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 5 Feb 2020.
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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.
Kathryn R Cullen, MD principal investigator
University of Minnesota
Ana Andreazza, PhD principal investigator
University of Toronto, Ontario
Bonnie Klimes-Dougan, PhD principal investigator
University of Minnesota
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depression and Bipolar Disorder, run by University of Minnesota at 2 sites 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 5 inclusion and 8 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 5 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Blood Analysis (time frame: Baseline). 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 5 Feb 2020.