Bipolar Proteomic Assay Validation Study

Completed

Conditions studied: Major Depressive Disorder, Bipolar I and Bipolar II

In brief

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.

Key facts

Study ID

NCT02746367

Run by

Myriad Genetic Laboratories, Inc.

People needed

261

Starts

2016-03-01

Expected to finish

2018-11-08

Last updated by the study team

2020-05-14

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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.

Where it is running

• University of Iowa Health Care, Department of Psychiatry — Iowa City, Iowa, United States
• University of Minnesota (UMN) Department of Psychiatry — Minneapolis, Minnesota, United States
• Lindner Center of HOPE/University of Cincinnati College of Medicine — Mason, Ohio, United States
• University of Pittsburgh Western Psychiatric Institute and Clinic — Pittsburgh, Pennsylvania, United States
• University of Texas Health Science Center — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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