Bipolar DisorderNCT03572426
Ion Channel Genetic Biomarkers: Diagnostic Capabilities in the Assessment of Bipolar Disorder
An observational study of Bipolar Disorder, run by University of Colorado, Denver at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Bipolar Disorder
- What is being tested?
- genotyping all subjects
- How many people
- 164 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jun 2018to 4 Apr 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Adult, Older adult
Study population: Caucasian and Latino
Who may be able to join
- presenting to one of 4 Denver Metro Area clinics
- Subjects must fall into one of 3 diagnostic categories, bipolar, MDD, or no mood symptoms.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Helen and Arthur E Johnson Depression Center
Aurora, Colorado, 80045
About this study
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.
Read the 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.
- Conditions
- Bipolar Disorder
- Being tested
- genotyping all subjects
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
genotyping all subjectsOther
genotyping using SNaPshot genotyping method.
| Study group | Role | What they receive |
|---|---|---|
| Bipolar | Diagnosed as having at least 1 lifetime manic episode by the MINI Receives: Other: genotyping all subjects | |
| Depression | Diagnosed as having at least 1 Major Depressive Episode by the MINI Receives: Other: genotyping all subjects | |
| Healthy Controls | Does not meet Criteria for any mood disorder diagnosis (MDD, BD, dysthymia) Receives: Other: genotyping all subjects |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (3)
Genetic Risk Score
Genetic risk score of selected SNPsrs1006737, rs10994336, rs10994133, rs2238071, rs1051375, rs1024582
Measured: 1 year
Family History
Positive family history of bipolar disorder in a first degree relative
Measured: 1 year
Adverse Childhood Experiences Scale
0-10 item scale assessing for adversity experienced during childhood
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2018
- Study start13 Jun 2018
- Primary completion4 Apr 2019
- Study completion4 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 164 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Sigma Theta Tau
- Responsible party
- Sponsor
- Investigators
- Kristiana Avery, PhD-c, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03572426
- Sponsor's protocol ID
- 17-1578
- Status last verified
- Jul 2019
- First submitted
- 13 Jun 2018
- Last updated
- 10 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ion Channel Genetic Biomarkers: Diagnostic Capabilities in the Assessment of Bipolar Disorder
- ClinicalTrials.gov ID
- NCT03572426
- Acronym / sponsor ID
- 17-1578
- Conditions
- Bipolar Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 164 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- Sigma Theta Tau
- Study start
- 13 Jun 2018 (actual)
- Primary completion
- 4 Apr 2019 (actual)
- Study completion
- 4 Apr 2019 (actual)
- First posted
- 28 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Bipolar | – | Other: genotyping all subjectsDiagnosed as having at least 1 lifetime manic episode by the MINI |
| Depression | – | Other: genotyping all subjectsDiagnosed as having at least 1 Major Depressive Episode by the MINI |
| Healthy Controls | – | Other: genotyping all subjectsDoes not meet Criteria for any mood disorder diagnosis (MDD, BD, dysthymia) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Caucasian and Latino
Key inclusion criteria (2 listed)
- presenting to one of 4 Denver Metro Area clinics
- Subjects must fall into one of 3 diagnostic categories, bipolar, MDD, or no mood symptoms.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| genotyping all subjectsgenotyping using SNaPshot genotyping method. | Other | Bipolar, Depression, Healthy Controls |
Primary outcome
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.
3 secondary outcomes
Genetic Risk Score
Time frame: 1 year
Family History
Time frame: 1 year
Adverse Childhood Experiences Scale
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kristiana Avery, PhD-c principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bipolar Disorder, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Logistic Regression (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2019.