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Completed

NCT Number: NCT03572426

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

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.

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Key information

Conditions

Bipolar Disorder Bipolar and Related Disorders Mental Disorders Mood Disorders

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Helen and Arthur E Johnson Depression Center

Aurora, Colorado, 80045, United States

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

genotyping all subjects

Other

genotyping using SNaPshot genotyping method.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • Sigma Theta Tau

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jun 28, 2018
Registry last updated
Jul 10, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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