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

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ClinicalTrials.gov Identifier: NCT03572426
Recruitment Status : Completed
First Posted : June 28, 2018
Last Update Posted : July 10, 2019
Sponsor:
Collaborator:
Sigma Theta Tau
Information provided by (Responsible Party):
University of Colorado, Denver

Study Description
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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.

Condition or disease Intervention/treatment
Bipolar Disorder Other: genotyping all subjects

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 Design
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Study Type : Observational
Actual Enrollment : 164 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Ion Channel Genetic Biomarkers: Diagnostic Capabilities in the Assessment of Bipolar Disorder
Actual Study Start Date : June 13, 2018
Actual Primary Completion Date : April 4, 2019
Actual Study Completion Date : April 4, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bipolar Disorder

Groups and Cohorts
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Genetic Risk Score [ Time Frame: 1 year ]
    Genetic risk score of selected SNPsrs1006737, rs10994336, rs10994133, rs2238071, rs1051375, rs1024582

  2. Family History [ Time Frame: 1 year ]
    Positive family history of bipolar disorder in a first degree relative

  3. Adverse Childhood Experiences Scale [ Time Frame: 1 year ]
    0-10 item scale assessing for adversity experienced during childhood


Biospecimen Retention:   Samples With DNA
Buccal Swab collect with genotyping done by SNaPshot.

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Caucasian and Latino
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03572426


Locations
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United States, Colorado
Helen and Arthur E Johnson Depression Center
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
Sigma Theta Tau
Investigators
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Principal Investigator: Kristiana Avery, PhD-c University of Colorado, Denver
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT03572426    
Other Study ID Numbers: 17-1578
First Posted: June 28, 2018    Key Record Dates
Last Update Posted: July 10, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Bipolar Disorder
Bipolar and Related Disorders
Mental Disorders