Bipolar Proteomic Assay Validation Study

NCT ID: NCT02746367

Last Updated: 2020-05-14

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 261 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-03-31
• Study Completion Date: 2018-11-08

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. 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.

Conditions

Major Depressive Disorder, Bipolar I and Bipolar II

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

MDD

Patients diagnosed with Major Depressive Disorder

Diagnostic test (LDT)

Intervention Type: OTHER

Proteomic assay

BPI

Patients diagnosed with bipolar I

Diagnostic test (LDT)

Intervention Type: OTHER

Proteomic assay

BPII

Patients diagnosed with bipolar II

Diagnostic test (LDT)

Intervention Type: OTHER

Proteomic assay

Interventions

Diagnostic test (LDT)

Proteomic assay

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Minnesota

OTHER

Sponsor Role: collaborator

Myriad Genetic Laboratories, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Countries

United States

Other Identifiers

EP-001

Identifier Type: -

Identifier Source: org_study_id