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

Sponsor
University of Colorado, Denver (Other)
Overall Status
Completed
CT.gov ID
NCT03572426
Collaborator
Sigma Theta Tau (Other)
164
1
9.7
16.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: genotyping all subjects

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 Design

Study Type:
Observational
Actual Enrollment :
164 participants
Observational Model:
Cohort
Time Perspective:
Cross-Sectional
Official Title:
Ion Channel Genetic Biomarkers: Diagnostic Capabilities in the Assessment of Bipolar Disorder
Actual Study Start Date :
Jun 13, 2018
Actual Primary Completion Date :
Apr 4, 2019
Actual Study Completion Date :
Apr 4, 2019

Arms and Interventions

Arm Intervention/Treatment
Bipolar

Diagnosed as having at least 1 lifetime manic episode by the MINI

Other: genotyping all subjects
genotyping using SNaPshot genotyping method.

Depression

Diagnosed as having at least 1 Major Depressive Episode by the MINI

Other: genotyping all subjects
genotyping using SNaPshot genotyping method.

Healthy Controls

Does not meet Criteria for any mood disorder diagnosis (MDD, BD, dysthymia)

Other: genotyping all subjects
genotyping using SNaPshot genotyping method.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. Genetic Risk Score [1 year]

    Genetic risk score of selected SNPsrs1006737, rs10994336, rs10994133, rs2238071, rs1051375, rs1024582

  2. Family History [1 year]

    Positive family history of bipolar disorder in a first degree relative

  3. Adverse Childhood Experiences Scale [1 year]

    0-10 item scale assessing for adversity experienced during childhood

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Helen and Arthur E Johnson Depression Center Aurora Colorado United States 80045

Sponsors and Collaborators

  • University of Colorado, Denver
  • Sigma Theta Tau

Investigators

  • Principal Investigator: Kristiana Avery, PhD-c, University of Colorado, Denver

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT03572426
Other Study ID Numbers:
  • 17-1578
First Posted:
Jun 28, 2018
Last Update Posted:
Jul 10, 2019
Last Verified:
Jul 1, 2019
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 10, 2019