Major Depressive Disorder, Bipolar I and Bipolar IINCT02746367
Bipolar Proteomic Assay Validation Study
An observational study of Major Depressive Disorder, Bipolar I and Bipolar II, run by Myriad Genetic Laboratories, Inc. at 5 sites in United States.
Trial summary
The purpose of this study is to validate a set of signatures, based on a panel of proteomic markers, that discriminate BDI, BDII, and MDD in people seeking treatment for a depressive episode. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Major Depressive Disorder, Bipolar I and Bipolar II
- What is being tested?
- Diagnostic test (LDT)
- How many people
- 261 participants
- Where
- 5 sitesUnited States
- Study dates
- Mar 2016to 8 Nov 2018
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients seeking treatment for new on-set depression from academic programs and affiliated community mental health facilities (inpatient and outpatient
Who may be able to join
- Diagnosed with BDI, BDII, or MDD, confirmed with the Structured Clinical Interview for DSM-5 (SCID).
- Currently depressed for ≥4 weeks and ≤104 weeks, without psychotic features,
- MADRS score ≥ 20 (consistent with at least moderately-severe depression)
- YMRS score ≤ 8 (consistent with the absence of hypomanic symptoms)
Who cannot join
- At high risk for suicide, defined as a score ≥4 on item 10 of the MADRS
- Current depression has psychotic features, diagnosed with the SCID
- Meeting criteria for severe alcohol, cannabis, or THC use disorders, as defined by DSM-5 and confirmed by the SCID, in the past 3 months, or meeting criteria for other substance use disorders of any severity (eg. cocaine use disorder). For substances other than alcohol, cannabis, and opioids, a positive drug screen at both the screening and baseline visits is also exclusionary. Caffeine and nicotine use disorders of any severity will not be exclusionary.
- Diagnosis of borderline personality disorder, diagnosed with the Zanarini Rating Scale for Borderline Personality Disorder.
- Medical conditions with neurological sequelae (eg. stroke, brain cancer, multiple sclerosis, loss of consciousness > 30 min, HIV)
- Severe chronic pain, at the discretion of the investigator
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- Receiving treatment with high-potency immune-modulating medications, such as corticosteroids, chemotherapy, monoclonal antibodies, or disease-modifying agents for arthritis, multiple sclerosis
- Any acute unstable medical illness (at the discretion of the site investigator)
- In MDD patients: strong risk factors for bipolarity, including 1) short (1-3 day) mood elevations not meeting DSM-5 time criteria for hypomania; 2) a family history of BDI or BDII in a first-degree relative; and 3) a history of antidepressant-induced symptoms suggestive of bipolarity, particularly antidepressant-induced hypo/mania.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
University of Iowa Health Care, Department of Psychiatry
Iowa City, Iowa, 52242
Lindner Center of HOPE/University of Cincinnati College of Medicine
Mason, Ohio, 45040
University of Minnesota (UMN) Department of Psychiatry
Minneapolis, Minnesota, 55414
University of Pittsburgh Western Psychiatric Institute and Clinic
Pittsburgh, Pennsylvania, 15213
University of Texas Health Science Center
San Antonio, Texas, 78229
About this study
Official title: A Validation Study to Measure the Impact of a Proteomic Assay in Distinguishing Bipolar I Disorder, Bipolar II Disorder, and Major Depressive Disorder in People Presenting With a Major Depressive Episode
The purpose of this study is to validate a set of signatures, based on a panel of proteomic markers, that discriminate BDI, BDII, and MDD in people seeking treatment for a depressive episode.
Read the detailed description
This is a hypothesis-driven confirmatory study to validate the diagnostic signature (model) for distinguishing BDI from MDD that also aims to optimize the models to discriminate BDII from MDD and BDI. A binary classification model, using linear discriminant analysis and based on 13 a priori-defined proteomic markers will aim to distinguish BDI from MDD. An alternative binary classification model based on multiple logistic regression and using 10 a priori -defined proteomic markers will aim for the same result. To improve the predictive performance of the signatures, items from self-report mood rating scales and treatment-emergent changes in proteomic markers will be analyzed. In addition, the study will examine if baseline or early treatment-emergent changes in proteomic markers predict treatment response.
- Being tested
- Diagnostic test (LDT)
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic test (LDT)Other
Proteomic assay
| Study group | Role | What they receive |
|---|---|---|
| MDD | Patients diagnosed with Major Depressive Disorder Receives: Other: Diagnostic test (LDT) | |
| BPI | Patients diagnosed with bipolar I Receives: Other: Diagnostic test (LDT) | |
| BPII | Patients diagnosed with bipolar II Receives: Other: Diagnostic test (LDT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Agreement between the model derived diagnosis (based on panel of serum proteomic markers) and the clinical diagnosis (confirmed by the SCID DSM-5)
Linear discriminant analysis and multiple logistic regression will be used to create three diagnostic models for the proteomic markers (BDI vs MDD, BDI vs BDII and BDII vs MDD). The patient's model diagnosis will be compared to the patient's clinical diagnoses (based on SCID DSM -5) and the proportion of concordant classifications will be calculated.
Measured: Baseline
Secondary outcomes (2)
Self-report clinical rating scales (IDS-SR30, PHQ-9, MDQ, HCL-32 and TEMPS-A)
Additional clinical characterization of the patient and their depressive episode will be obtained through analysis of the self-report clinical rating scales and used to optimize the predictive performance of the proteomic signatures.
Measured: Baseline, Week 2 and Week 8
Changes in proteomic markers at Week 2 and Week 8
Proteomic markers will be analyzed at weeks 2 and 8 to observe for any treatment-emergent changes to increase the predictive validity of the proteomic signatures.
Measured: Week 2 and Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2016 (estimated)
- Study startMar 2016
- Primary completion8 Nov 2018
- Study completion8 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive Disorder, Bipolar I and Bipolar IIStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 261 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Myriad Genetic Laboratories, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Minnesota
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02746367
- Sponsor's protocol ID
- EP-001
- Status last verified
- Mar 2019
- First submitted
- 12 Apr 2016
- Last updated
- 14 May 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Validation Study to Measure the Impact of a Proteomic Assay in Distinguishing Bipolar I Disorder, Bipolar II Disorder, and Major Depressive Disorder in People Presenting With a Major Depressive Episode
- ClinicalTrials.gov ID
- NCT02746367
- Acronym / sponsor ID
- EP-001
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 261 participants (estimated)
- Lead sponsor
- Myriad Genetic Laboratories, Inc.Industry (pharma, biotech, devices)
- Collaborators
- University of Minnesota
- Study start
- Mar 2016
- Primary completion
- 8 Nov 2018 (actual)
- Study completion
- 8 Nov 2018 (actual)
- First posted
- 21 Apr 2016 (estimated)
- 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.
The purpose of this study is to validate a set of signatures, based on a panel of proteomic markers, that discriminate BDI, BDII, and MDD in people seeking treatment for a depressive episode.
Detailed description
This is a hypothesis-driven confirmatory study to validate the diagnostic signature (model) for distinguishing BDI from MDD that also aims to optimize the models to discriminate BDII from MDD and BDI. A binary classification model, using linear discriminant analysis and based on 13 a priori-defined proteomic markers will aim to distinguish BDI from MDD. An alternative binary classification model based on multiple logistic regression and using 10 a priori -defined proteomic markers will aim for the same result. To improve the predictive performance of the signatures, items from self-report mood rating scales and treatment-emergent changes in proteomic markers will be analyzed. In addition, the study will examine if baseline or early treatment-emergent changes in proteomic markers predict treatment response.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MDD | – | Other: Diagnostic test (LDT)Patients diagnosed with Major Depressive Disorder |
| BPI | – | Other: Diagnostic test (LDT)Patients diagnosed with bipolar I |
| BPII | – | Other: Diagnostic test (LDT)Patients diagnosed with bipolar II |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients seeking treatment for new on-set depression from academic programs and affiliated community mental health facilities (inpatient and outpatient
Key inclusion criteria (4 listed)
- Diagnosed with BDI, BDII, or MDD, confirmed with the Structured Clinical Interview for DSM-5 (SCID).
- Currently depressed for ≥4 weeks and ≤104 weeks, without psychotic features,
- MADRS score ≥ 20 (consistent with at least moderately-severe depression)
- YMRS score ≤ 8 (consistent with the absence of hypomanic symptoms)
Key exclusion criteria (9 listed)
- At high risk for suicide, defined as a score ≥4 on item 10 of the MADRS
- Current depression has psychotic features, diagnosed with the SCID
- Meeting criteria for severe alcohol, cannabis, or THC use disorders, as defined by DSM-5 and confirmed by the SCID, in the past 3 months, or meeting criteria for other substance use disorders of any severity (eg. cocaine use disorder). For substances other than alcohol, cannabis, and opioids, a positive drug screen at both the screening and baseline visits is also exclusionary. Caffeine and nicotine use disorders of any severity will not be exclusionary.
- Diagnosis of borderline personality disorder, diagnosed with the Zanarini Rating Scale for Borderline Personality Disorder.
- Medical conditions with neurological sequelae (eg. stroke, brain cancer, multiple sclerosis, loss of consciousness > 30 min, HIV)
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 |
|---|---|---|
| Diagnostic test (LDT)Proteomic assay | Other | BPI, BPII, MDD |
Primary outcome
Agreement between the model derived diagnosis (based on panel of serum proteomic markers) and the clinical diagnosis (confirmed by the SCID DSM-5)
Time frame: Baseline
Linear discriminant analysis and multiple logistic regression will be used to create three diagnostic models for the proteomic markers (BDI vs MDD, BDI vs BDII and BDII vs MDD). The patient's model diagnosis will be compared to the patient's clinical diagnoses (based on SCID DSM -5) and the proportion of concordant classifications will be calculated.
2 secondary outcomes
Self-report clinical rating scales (IDS-SR30, PHQ-9, MDQ, HCL-32 and TEMPS-A)
Time frame: Baseline, Week 2 and Week 8
Changes in proteomic markers at Week 2 and Week 8
Time frame: Week 2 and Week 8
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 14 May 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Major Depressive Disorder, Bipolar I and Bipolar II, run by Myriad Genetic Laboratories, Inc. at 5 sites 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 4 inclusion and 9 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 14 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
Agreement between the model derived diagnosis (based on panel of serum proteomic markers) and the clinical diagnosis (confirmed by the SCID DSM-5) (time frame: Baseline). 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 14 May 2020.