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NCT03572426 Clinical Trial

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

Bipolar Disorder Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03572426
Other study ID # 17-1578
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 13, 2018
Est. completion date April 4, 2019

Study information
Verified date July 2019
Source University of Colorado, Denver
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 164
Est. completion date April 4, 2019
Est. primary completion date April 4, 2019
Accepts healthy volunteers
Gender All
Age group 18 Years to 80 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Other:
• genotyping all subjects
genotyping using SNaPshot genotyping method.

Locations
Country Name City State
United States Helen and Arthur E Johnson Depression Center Aurora Colorado

Sponsors (2)
Lead Sponsor Collaborator
University of Colorado, Denver Sigma Theta Tau

Country where clinical trial is conducted

United States, 

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