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

NCT ID: NCT03572426

Last Updated: 2019-07-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

164 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-06-13

Study Completion Date

2019-04-04

Brief Summary

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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

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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.

Conditions

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Bipolar Disorder

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Bipolar

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

genotyping all subjects

Intervention Type OTHER

genotyping using SNaPshot genotyping method.

Depression

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

genotyping all subjects

Intervention Type OTHER

genotyping using SNaPshot genotyping method.

Healthy Controls

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

genotyping all subjects

Intervention Type OTHER

genotyping using SNaPshot genotyping method.

Interventions

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genotyping all subjects

genotyping using SNaPshot genotyping method.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sigma Theta Tau

UNKNOWN

Sponsor Role collaborator

University of Colorado, Denver

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kristiana Avery, PhD-c

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

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Helen and Arthur E Johnson Depression Center

Aurora, Colorado, United States

Site Status

Countries

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United States

Other Identifiers

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17-1578

Identifier Type: -

Identifier Source: org_study_id

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