Major Depressive Disorder, Bipolar I and Bipolar II Clinical Trial
Official title:
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
| NCT number | NCT02746367 |
| Other study ID # | EP-001 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | March 2016 |
| Est. completion date | November 8, 2018 |
| Verified date | March 2019 |
| Source | Myriad Genetic Laboratories, Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 261 |
| Est. completion date | November 8, 2018 |
| Est. primary completion date | November 8, 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 70 Years |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| United States | University of Iowa Health Care, Department of Psychiatry | Iowa City | Iowa |
| United States | Lindner Center of HOPE/University of Cincinnati College of Medicine | Mason | Ohio |
| United States | University of Minnesota (UMN) Department of Psychiatry | Minneapolis | Minnesota |
| United States | University of Pittsburgh Western Psychiatric Institute and Clinic | Pittsburgh | Pennsylvania |
| United States | University of Texas Health Science Center | San Antonio | Texas |
| Lead Sponsor | Collaborator |
|---|---|
| Myriad Genetic Laboratories, Inc. | University of Minnesota |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Treatment response (> 50% improvement in MADRS score) | Distinguish responders from non-responders by measuring MADRS and determine if baseline or treatment-emergent changes in proteomic markers predict treatment response. | Baseline, Week 8 | |
| Other | Remission (MADRS score < 8) | Distinguish remitters from non-remitters by measuring MADRS and determine if baseline or treatment-emergent changes in proteomic markers predict treatment response. | Baseline, Week 8 | |
| Other | Antidepressant-induced hypo/mania (YMRS score > 12) | Compare incidence of antidepressant-induced hypo/manic episodes (defined as YMRS score > 12) to changes in proteomic markers to predict treatment response. | Baseline, Week 2, Week 4, Week 6 | |
| Primary | 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 | Self-report clinical rating scales (IDS-SR30, PHQ-9, MDQ, HCL-32 and TEMPS-A) | 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. | Baseline, Week 2 and Week 8 | |
| Secondary | Changes in proteomic markers at 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. | Week 2 and Week 8 |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
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