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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 : Recruiting
First Posted : June 28, 2018
Last Update Posted : June 28, 2018
Sponsor:
Collaborator:
Sigma Theta Tau
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Bipolar Disorder 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.

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Study Type : Observational
Estimated 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 : June 13, 2018
Estimated Primary Completion Date : April 1, 2019
Estimated Study Completion Date : December 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bipolar Disorder

Group/Cohort 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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Genetic Risk Score [ Time Frame: 1 year ]
    Genetic risk score of selected SNPsrs1006737, rs10994336, rs10994133, rs2238071, rs1051375, rs1024582

  2. Family History [ Time Frame: 1 year ]
    Positive family history of bipolar disorder in a first degree relative

  3. Adverse Childhood Experiences Scale [ Time Frame: 1 year ]
    0-10 item scale assessing for adversity experienced during childhood


Biospecimen Retention:   Samples With DNA
Buccal Swab collect with genotyping done by SNaPshot.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Caucasian and Latino
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03572426


Contacts
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Contact: Kristiana Avery, PhD-c 303-481-3451 ext 2 kristiana.avery@ucdenver.edu

Locations
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United States, Colorado
Helen and Arthur E Johnson Depression Center Recruiting
Aurora, Colorado, United States, 80045
Contact: Kristiana Avery, PhD-c    303-481-3451 ext 2    kristiana.avery@ucdenver.edu   
Sponsors and Collaborators
University of Colorado, Denver
Sigma Theta Tau
Investigators
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Principal Investigator: Kristiana Avery, PhD-c University of Colorado, Denver

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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT03572426     History of Changes
Other Study ID Numbers: 17-1578
First Posted: June 28, 2018    Key Record Dates
Last Update Posted: June 28, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Disease
Bipolar Disorder
Pathologic Processes
Bipolar and Related Disorders
Mental Disorders