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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03572426

Enrollment

164

Registered

2018-06-28

Start date

2018-06-13

Completion date

2019-04-04

Last updated

2019-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bipolar Disorder

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.

Interventions

OTHERgenotyping all subjects

genotyping using SNaPshot genotyping method.

Study design

Observational model

COHORT

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026