Bipolar Proteomic Assay Validation Study
- Conditions
- Major Depressive Disorder, Bipolar I and Bipolar II
- Interventions
- Other: Diagnostic test (LDT)
- Registration Number
- NCT02746367
- Lead Sponsor
- Myriad Genetic Laboratories, Inc.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 261
- 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)
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description BPI Diagnostic test (LDT) Patients diagnosed with bipolar I MDD Diagnostic test (LDT) Patients diagnosed with Major Depressive Disorder BPII Diagnostic test (LDT) Patients diagnosed with bipolar II
- Primary Outcome Measures
Name Time Method Agreement between the model derived diagnosis (based on panel of serum proteomic markers) and the clinical diagnosis (confirmed by the SCID DSM-5) 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.
- Secondary Outcome Measures
Name Time Method Self-report clinical rating scales (IDS-SR30, PHQ-9, MDQ, HCL-32 and TEMPS-A) Baseline, Week 2 and Week 8 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.
Changes in proteomic markers at Week 2 and Week 8 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.
Trial Locations
- Locations (5)
Lindner Center of HOPE/University of Cincinnati College of Medicine
🇺🇸Mason, Ohio, United States
University of Iowa Health Care, Department of Psychiatry
🇺🇸Iowa City, Iowa, United States
University of Pittsburgh Western Psychiatric Institute and Clinic
🇺🇸Pittsburgh, Pennsylvania, United States
University of Minnesota (UMN) Department of Psychiatry
🇺🇸Minneapolis, Minnesota, United States
University of Texas Health Science Center
🇺🇸San Antonio, Texas, United States