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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Bipolar Disorder

Intervention / Treatment
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* Other: genotyping all subjects


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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