NCT03572426

Brief Summary

Genotype 164 adults to evaluate six selected single nucleotide polymorphisms (SNPs) (rs1006737, rs10994336, rs10994133, rs2238071, rs1051375, rs1024582) for use as a genetic biomarker to differentiate between bipolar depression and unipolar depression.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
164

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

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

June 13, 2018

Completed
Same day until next milestone

Study Start

First participant enrolled

June 13, 2018

Completed
15 days until next milestone

First Posted

Study publicly available on registry

June 28, 2018

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 4, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 4, 2019

Completed
Last Updated

July 10, 2019

Status Verified

July 1, 2019

Enrollment Period

10 months

First QC Date

June 13, 2018

Last Update Submit

July 8, 2019

Conditions

Bipolar Disorder

Outcome Measures

Primary Outcomes (1)

  • Logistic Regression

    Logistic regression will be used to examine a genetic risk score using a risk allele count as the independent variable, with a diagnosis of BD versus MDD versus those with no mood diagnosis as the dependent variable.

    1 year

Secondary Outcomes (3)

  • Genetic Risk Score

    1 year

  • Family History

    1 year

  • Adverse Childhood Experiences Scale

    1 year

Study Arms (3)

Bipolar

Diagnosed as having at least 1 lifetime manic episode by the MINI

Other: genotyping all subjects

Depression

Diagnosed as having at least 1 Major Depressive Episode by the MINI

Other: genotyping all subjects

Healthy Controls

Does not meet Criteria for any mood disorder diagnosis (MDD, BD, dysthymia)

Other: genotyping all subjects

Interventions

genotyping all subjectsOTHER

genotyping using SNaPshot genotyping method.

BipolarDepressionHealthy Controls

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Caucasian and Latino

You may qualify if:

  • presenting to one of 4 Denver Metro Area clinics
  • Subjects must fall into one of 3 diagnostic categories, bipolar, MDD, or no mood symptoms.

You may not qualify if:

  • Inability to provide informed consent
  • history of TBI
  • history of untreated seizure disorder
  • substance abuse in the last 8 hours
  • moderate-severe substance abuse disorder diagnosed in the last 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Helen and Arthur E Johnson Depression Center

Aurora, Colorado, 80045, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Buccal Swab collect with genotyping done by SNaPshot.

MeSH Terms

Conditions

Bipolar Disorder

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental Disorders

Study Officials

  • Kristiana Avery, PhD-c

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 13, 2018

First Posted

June 28, 2018

Study Start

June 13, 2018

Primary Completion

April 4, 2019

Study Completion

April 4, 2019

Last Updated

July 10, 2019

Record last verified: 2019-07

Locations

US(1)