Status:
COMPLETED
Bipolar Proteomic Assay Validation Study
Lead Sponsor:
Myriad Genetic Laboratories, Inc.
Collaborating Sponsors:
University of Minnesota
Conditions:
Major Depressive Disorder, Bipolar I and Bipolar II
Eligibility:
All Genders
18-70 years
Brief 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.
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....
Eligibility Criteria
Inclusion
- 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)
Exclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2016
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
November 8 2018
Estimated Enrollment :
261 Patients enrolled
Trial Details
Trial ID
NCT02746367
Start Date
March 1 2016
End Date
November 8 2018
Last Update
May 14 2020
Active Locations (5)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Iowa Health Care, Department of Psychiatry
Iowa City, Iowa, United States, 52242
2
University of Minnesota (UMN) Department of Psychiatry
Minneapolis, Minnesota, United States, 55414
3
Lindner Center of HOPE/University of Cincinnati College of Medicine
Mason, Ohio, United States, 45040
4
University of Pittsburgh Western Psychiatric Institute and Clinic
Pittsburgh, Pennsylvania, United States, 15213