Clinical trial NCT02596698: Mitochondrial Dysfunction, Inflammation, and White Matter Integrity in Youth With Mood Disorders
Official title: Mitochondrial Dysfunction, Inflammation, and White Matter Integrity in Youth With Mood Disorders
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Depression
Bipolar Disorder
Bipolar Disorder Not Otherwise Specified
Unspecified Mood Disorder
Keywords: Mood Disorder
Lead sponsor: University of Minnesota
Sponsor class: OTHER
Collaborators: name: Ontario Mental Health Foundation
First posted: 2015-11-04
Enrollment: 54
Sex: ALL
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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.

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.

Eligibility criteria: Inclusion Criteria - All Participants:

* Age 13-18 years old
* Both child and guardian are English speaking

Inclusion Criteria - Patient Group:

* 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)

Inclusion Criteria - Healthy Controls

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Blood Analysis
timeFrame: Baseline
Secondary outcomes:
measure: MRI Data
timeFrame: Up to 6 weeks after baseline
measure: Saliva Cortisol
timeFrame: Up to 6 weeks of baseline
measure: Beck Depression Inventory (BDI-II)
timeFrame: Baseline and within 6 weeks of baseline
measure: Children's Depression Rating Scale - Revised (CDRS-R)
timeFrame: Baseline
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Ambulatory Research Center (ARC)
state: Minnesota
city: Minneapolis
country: United States
facility: Center for Magnetic Resonance Research
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Kathryn R Cullen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Toronto, Ontario
name: Ana Andreazza, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Minnesota
name: Bonnie Klimes-Dougan, PhD
role: PRINCIPAL_INVESTIGATOR
References: