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

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ClinicalTrials.gov Identifier: NCT03572426
Recruitment Status : Completed
First Posted : June 28, 2018
Last Update Posted : July 10, 2019
Sponsor:
Collaborator:
Sigma Theta Tau
Information provided by (Responsible Party):
University of Colorado, Denver

Tracking Information
First Submitted Date June 13, 2018
First Posted Date June 28, 2018
Last Update Posted Date July 10, 2019
Actual Study Start Date June 13, 2018
Actual Primary Completion Date April 4, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 26, 2018)
Logistic Regression [ Time Frame: 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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: June 26, 2018)
  • Genetic Risk Score [ Time Frame: 1 year ]
    Genetic risk score of selected SNPsrs1006737, rs10994336, rs10994133, rs2238071, rs1051375, rs1024582
  • Family History [ Time Frame: 1 year ]
    Positive family history of bipolar disorder in a first degree relative
  • Adverse Childhood Experiences Scale [ Time Frame: 1 year ]
    0-10 item scale assessing for adversity experienced during childhood
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Ion Channel Genetic Biomarkers: Diagnostic Capabilities in the Assessment of Bipolar Disorder
Official Title Ion Channel Genetic Biomarkers: Diagnostic Capabilities in the Assessment of 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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Buccal Swab collect with genotyping done by SNaPshot.
Sampling Method Non-Probability Sample
Study Population Caucasian and Latino
Condition Bipolar Disorder
Intervention Other: genotyping all subjects
genotyping using SNaPshot genotyping method.
Study Groups/Cohorts
  • Bipolar
    Diagnosed as having at least 1 lifetime manic episode by the MINI
    Intervention: Other: genotyping all subjects
  • Depression
    Diagnosed as having at least 1 Major Depressive Episode by the MINI
    Intervention: Other: genotyping all subjects
  • Healthy Controls
    Does not meet Criteria for any mood disorder diagnosis (MDD, BD, dysthymia)
    Intervention: Other: genotyping all subjects
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 26, 2018)
164
Original Estimated Enrollment Same as current
Actual Study Completion Date April 4, 2019
Actual Primary Completion Date April 4, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03572426
Other Study ID Numbers 17-1578
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party University of Colorado, Denver
Study Sponsor University of Colorado, Denver
Collaborators Sigma Theta Tau
Investigators
Principal Investigator: Kristiana Avery, PhD-c University of Colorado, Denver
PRS Account University of Colorado, Denver
Verification Date July 2019