NCT02596698

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2015

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 13, 2015

Completed
18 days until next milestone

Study Start

First participant enrolled

October 31, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 4, 2015

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2018

Completed
Last Updated

February 5, 2020

Status Verified

January 1, 2020

Enrollment Period

2.4 years

First QC Date

October 13, 2015

Last Update Submit

January 31, 2020

Conditions

DepressionBipolar DisorderBipolar Disorder Not Otherwise SpecifiedUnspecified Mood Disorder

Keywords

Mood Disorder

Outcome Measures

Primary Outcomes (1)

  • 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

    Baseline

Secondary Outcomes (4)

  • MRI Data

    Up to 6 weeks after baseline

  • Saliva Cortisol

    Up to 6 weeks of baseline

  • Beck Depression Inventory (BDI-II)

    Baseline and within 6 weeks of baseline

  • Children's Depression Rating Scale - Revised (CDRS-R)

    Baseline

Study Arms (2)

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

Eligibility Criteria

Age13 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Ambulatory Research Center (ARC)

Minneapolis, Minnesota, 55454, United States

Location

Center for Magnetic Resonance Research

Minneapolis, Minnesota, 55455, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

We will keep de-identified saliva and blood samples for analysis until the completion of the study. Samples will then be destroyed.

MeSH Terms

Conditions

DepressionBipolar DisorderMood Disorders

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorBipolar and Related DisordersMental Disorders

Study Officials

  • Kathryn R Cullen, MD

    University of Minnesota

    PRINCIPAL INVESTIGATOR

  • Ana Andreazza, PhD

    University of Toronto, Ontario

    PRINCIPAL INVESTIGATOR

  • Bonnie Klimes-Dougan, PhD

    University of Minnesota

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 13, 2015

First Posted

November 4, 2015

Study Start

October 31, 2015

Primary Completion

March 31, 2018

Study Completion

March 31, 2018

Last Updated

February 5, 2020

Record last verified: 2020-01

Locations

US(2)