Mitochondrial Dysfunction, Inflammation, and White Matter Integrity in Youth With Mood Disorders

NCT ID: NCT02596698

Last Updated: 2020-02-05

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 54 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-10-31
• Study Completion Date: 2018-03-31

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.

Conditions

Depression; Bipolar Disorder; Bipolar Disorder Not Otherwise Specified; Unspecified Mood Disorder

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Adolescents with Mood Disorders

Teens aged 13-18 with a diagnosis of a mood disorder.

No interventions assigned to this group

Adolescents with no Mental Health Diagnoses

13-18, no psychiatric d/o diagnosis

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• 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

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

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ontario Mental Health Foundation

OTHER_GOV

Sponsor Role: collaborator

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kathryn R Cullen, MD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Ana Andreazza, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Toronto, Ontario

Bonnie Klimes-Dougan, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

Ambulatory Research Center (ARC)

Minneapolis, Minnesota, United States

Center for Magnetic Resonance Research

Minneapolis, Minnesota, United States

Countries

United States

Other Identifiers

1507M75201

Identifier Type: -

Identifier Source: org_study_id