Bipolar Proteomic Assay Validation Study

NCT02746367 | Completed

• 1 other identifier: EP-001
• Study Type: observational
• Target: 261
• Locations: 1 country
• Sites: 5

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.

Conditions

Major Depressive Disorder, Bipolar I and Bipolar II

Outcome Measures

Primary Outcomes (1)

• Agreement between the model derived diagnosis (based on panel of serum proteomic markers) and the clinical diagnosis (confirmed by the SCID DSM-5)

  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.

  Baseline

Secondary Outcomes (2)

• Self-report clinical rating scales (IDS-SR30, PHQ-9, MDQ, HCL-32 and TEMPS-A)

  Baseline, Week 2 and Week 8

• Changes in proteomic markers at Week 2 and Week 8

  Week 2 and Week 8

Other Outcomes (3)

• Treatment response (> 50% improvement in MADRS score)

  Baseline, Week 8

• Remission (MADRS score < 8)

  Baseline, Week 8

• Antidepressant-induced hypo/mania (YMRS score > 12)

  Baseline, Week 2, Week 4, Week 6

Study Arms (3)

MDD

Patients diagnosed with Major Depressive Disorder

Other: Diagnostic test (LDT)

BPI

Patients diagnosed with bipolar I

Other: Diagnostic test (LDT)

BPII

Patients diagnosed with bipolar II

Other: Diagnostic test (LDT)

Interventions

Diagnostic test (LDT) OTHER

Proteomic assay

BPI; BPII; MDD

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients seeking treatment for new on-set depression from academic programs and affiliated community mental health facilities (inpatient and outpatient

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
• 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.

Sponsors & Collaborators

• Myriad Genetic Laboratories, Inc.: lead
• University of Minnesota: collaborator

Study Sites (5)

University of Iowa Health Care, Department of Psychiatry

Iowa City, Iowa, 52242, United States

Location

University of Minnesota (UMN) Department of Psychiatry

Minneapolis, Minnesota, 55414, United States

Location

Lindner Center of HOPE/University of Cincinnati College of Medicine

Mason, Ohio, 45040, United States

Location

University of Pittsburgh Western Psychiatric Institute and Clinic

Pittsburgh, Pennsylvania, 15213, United States

Location

University of Texas Health Science Center

San Antonio, Texas, 78229, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Telbivudine

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Thymidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2016
• First Posted: April 21, 2016
• Study Start: March 1, 2016
• Primary Completion: November 8, 2018
• Study Completion: November 8, 2018
• Last Updated: May 14, 2020

Record last verified: 2019-03

Locations

US (5)