NCT02746367

Bipolar Proteomic Assay Validation Study

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 261 (estimated)
• Sponsor: Myriad Genetic Laboratories, Inc. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
OTHER	Diagnostic test (LDT)	Proteomic assay

Timeline

• Start date: 2016-03-01
• Primary completion: 2018-11-08
• Completion: 2018-11-08
• First posted: 2016-04-21
• Last updated: 2020-05-14

Locations

5 sites across 1 country: United States