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

Completed

• Conditions: Bipolar Disorder
• Interventions: Other: genotyping all subjects

• Registration Number: NCT03572426
• Lead Sponsor: University of Colorado, Denver

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.

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 Timeline

• Study Start: 2018-06-13
• Study First Submitted: 2018-06-13
• Study First Submitted QC: 2018-06-26
• Study First Posted: 2018-06-28
• Primary Completion: 2019-04-04
• Study Completion: 2019-04-04
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-08
• Last Update Posted: 2019-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 164

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy Controls	genotyping all subjects	Does not meet Criteria for any mood disorder diagnosis (MDD, BD, dysthymia)
Bipolar	genotyping all subjects	Diagnosed as having at least 1 lifetime manic episode by the MINI
Depression	genotyping all subjects	Diagnosed as having at least 1 Major Depressive Episode by the MINI

Primary Outcome Measures

Name	Time	Method
Logistic Regression	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

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

Trial Locations

Locations (1)

Helen and Arthur E Johnson Depression Center; 🇺🇸 Aurora, Colorado, United States