Mitochondrial Dysfunction, Inflammation, and White Matter Integrity in Youth With Mood Disorders
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|ClinicalTrials.gov Identifier: NCT02596698|
Recruitment Status : Recruiting
First Posted : November 4, 2015
Last Update Posted : November 24, 2017
|Condition or disease|
|Depression Bipolar Disorder Bipolar Disorder Not Otherwise Specified Unspecified Mood Disorder|
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 Type :||Observational|
|Estimated Enrollment :||60 participants|
|Official Title:||Mitochondrial Dysfunction, Inflammation, and White Matter Integrity in Youth With Mood Disorders|
|Study Start Date :||October 2015|
|Estimated Primary Completion Date :||March 2018|
|Estimated Study Completion Date :||March 2018|
Adolescents with Mood Disorders
Teens aged 13-18 with a diagnosis of a mood disorder.
Adolescents with no Mental Health Diagnoses
Teens aged 13-18 who do not meet criteria for any psychiatric disorders.
- 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
- MRI Data [ Time Frame: Up to 6 weeks after baseline ]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
- Saliva Cortisol [ Time Frame: Up to 6 weeks of baseline ]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.
- Beck Depression Inventory (BDI-II) [ Time Frame: Baseline and within 6 weeks of baseline ]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.
- Children's Depression Rating Scale - Revised (CDRS-R) [ Time Frame: Baseline ]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.
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02596698
|Contact: Nathan A Horek, NMDemail@example.com|
|Contact: Kathryn R Cullen, MDfirstname.lastname@example.org|
|United States, Minnesota|
|Ambulatory Research Center (ARC)||Recruiting|
|Minneapolis, Minnesota, United States, 55454|
|Contact: Nathan A Horek, NMD 612-626-7635 email@example.com|
|Center for Magnetic Resonance Research||Recruiting|
|Minneapolis, Minnesota, United States, 55455|
|Contact: Nathan A Horek, NMD 612-626-7635 firstname.lastname@example.org|
|Principal Investigator:||Kathryn R Cullen, MD||University of Minnesota - Clinical and Translational Science Institute|
|Principal Investigator:||Ana Andreazza, PhD||University of Toronto, Ontario|
|Principal Investigator:||Bonnie Klimes-Dougan, PhD||University of Minnesota - Clinical and Translational Science Institute|