Ion Channel Genetic Biomarkers: Diagnostic Capabilities in the Assessment of Bipolar Disorder

July 8, 2019 updated by: University of Colorado, Denver
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Adults ages 18-80 will be recruited if they are diagnosed with bipolar disorder, major depression, or have no mood symptoms. The adults will undergo a diagnostic interview, the Mini International Neuropsychiatric Interview (MINI) for the diagnosis. The subjects will also complete the Adverse Childhood Events Scale to evaluate for a genetic x environmental interaction in detecting bipolar disorder at initial assessment. Genotyping will be done by SNaPshot genotyping method and genetic sample will be collected via buccal swab.

Study Type

Observational

Enrollment (Actual)

164

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Helen and Arthur E Johnson Depression Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Caucasian and Latino

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Bipolar
Diagnosed as having at least 1 lifetime manic episode by the MINI
Other: genotyping all subjects
genotyping using SNaPshot genotyping method.
Depression
Diagnosed as having at least 1 Major Depressive Episode by the MINI
Other: genotyping all subjects
genotyping using SNaPshot genotyping method.
Healthy Controls
Does not meet Criteria for any mood disorder diagnosis (MDD, BD, dysthymia)
Other: genotyping all subjects
genotyping using SNaPshot genotyping method.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Logistic Regression
Time Frame: 1 year
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Genetic Risk Score
Time Frame: 1 year
Genetic risk score of selected SNPsrs1006737, rs10994336, rs10994133, rs2238071, rs1051375, rs1024582
1 year
Family History
Time Frame: 1 year
Positive family history of bipolar disorder in a first degree relative
1 year
Adverse Childhood Experiences Scale
Time Frame: 1 year
0-10 item scale assessing for adversity experienced during childhood
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Colorado, Denver

Collaborators

Sigma Theta Tau

Investigators

  • Principal Investigator: Kristiana Avery, PhD-c, University of Colorado, Denver

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 13, 2018

Primary Completion (Actual)

April 4, 2019

Study Completion (Actual)

April 4, 2019

Study Registration Dates

First Submitted

June 13, 2018

First Submitted That Met QC Criteria

June 26, 2018

First Posted (Actual)

June 28, 2018

Study Record Updates

Last Update Posted (Actual)

July 10, 2019

Last Update Submitted That Met QC Criteria

July 8, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17-1578

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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