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

31 de enero de 2020 actualizado por: University of Minnesota
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.

Descripción general del estudio

Descripción detallada

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.

Tipo de estudio

De observación

Inscripción (Actual)

54

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

    • Minnesota
      • Minneapolis, Minnesota, Estados Unidos, 55454
        • Ambulatory Research Center (ARC)
      • Minneapolis, Minnesota, Estados Unidos, 55455
        • Center for Magnetic Resonance Research

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

13 años a 18 años (Niño, Adulto)

Acepta Voluntarios Saludables

Géneros elegibles para el estudio

Todos

Método de muestreo

Muestra no probabilística

Población de estudio

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.

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

Cohortes e Intervenciones

Grupo / Cohorte
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

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Blood Analysis
Periodo de tiempo: 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
Baseline

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
MRI Data
Periodo de tiempo: 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
Up to 6 weeks after baseline
Saliva Cortisol
Periodo de tiempo: 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.
Up to 6 weeks of baseline
Beck Depression Inventory (BDI-II)
Periodo de tiempo: 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.
Baseline and within 6 weeks of baseline
Children's Depression Rating Scale - Revised (CDRS-R)
Periodo de tiempo: 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.
Baseline

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

  • Investigador principal: Kathryn R Cullen, MD, University of Minnesota
  • Investigador principal: Ana Andreazza, PhD, University of Toronto, Ontario
  • Investigador principal: Bonnie Klimes-Dougan, PhD, University of Minnesota

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

31 de octubre de 2015

Finalización primaria (Actual)

31 de marzo de 2018

Finalización del estudio (Actual)

31 de marzo de 2018

Fechas de registro del estudio

Enviado por primera vez

13 de octubre de 2015

Primero enviado que cumplió con los criterios de control de calidad

3 de noviembre de 2015

Publicado por primera vez (Estimar)

4 de noviembre de 2015

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

5 de febrero de 2020

Última actualización enviada que cumplió con los criterios de control de calidad

31 de enero de 2020

Última verificación

1 de enero de 2020

Más información

Términos relacionados con este estudio

Palabras clave

Otros números de identificación del estudio

  • 1507M75201

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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