BIOMARKER DISCOVERY PROJECT

ABOUT THE BIOMARKER DISCOVERY PROJECT

This program has been generously funded by a gift from a University of Michigan Comprehensive Depression Center donor.

This multi-site (Mayo ClinicUniversity of CincinnatiUniversity of PennsylvaniaJohns HopkinsUniversity of MichiganUniversity of California San Francisco) open label clinical trial is designed to identify biomarkers of  acute  response patterns to ketamine in 40 (100) patients with treatment resistant depression (TRD) with suicidal ideation/attempt. The primary outcome will be remission as defined by a Montgomery Åsberg Depression Scale (MÅDRS) score ≤9. The secondary outcome measures include reduction of suicidality as defined by a 50% reduction in the Suicide Status Form (SSF II-R) score and self-report remission of symptoms as defined by a Quick Inventory of Depressive Symptomatology Self-Report of ≤5. Exploratory biomarker outcomes include baseline to endpoint change in serum kynurenic acid and WBC stimulated mTOR, AKT, and GSK3 signaling.

The therapeutic potential of ketamine (i.e. rapid symptom relief and response in treatment-resistant patients) has stimulated considerable interest in the psychiatric community, and the clinical use of ketamine infusion for the treatment of depression is now an intense focus of research worldwide. However, further progress is challenged by the absence of reliable and valid predictors of antidepressive response to ketamine. Reliable biomarkers of ketamine response would allow clinicians to better assess which patients would be the best candidates for ketamine treatment. In this trial, investigators from seven NNDC sites will enroll a total of 100 patients with treatment resistant unipolar or bipolar major depression and provide three low-dose IV ketamine infusions (0.5 mg/kg over 100 minutes) and measure their depressive symptom responses. Blood-based biomarkers will be developed using blood samples from study subjects, taken prior to (predictive biomarkers) and following ketamine treatment (change biomarkers). This program has been generously funded by a gift from a University of Michigan Comprehensive Depression Center donor.

Visit the ClinicalTrials.gov page: “The BIO-K Study: A Single-Arm, Open-Label, Biomarker Development Clinical Trial of Ketamine for Non-Psychotic Unipolar Major Depression and Bipolar I or II Depression”

PRIMARY INVESTIGATORS

JOHN F. GREDEN, MD

University of Michigan
Steering Committee

MARK FRYE, MD

Mayo Clinic
Steering Committee

SAGAR PARIKH, MD

University of Michigan
Steering Committee
Data Collection & Management Team

WILLIAM BOBO, MD

Mayo Clinic
Steering Committee

SRIJAN SEN, PHD

University of Michigan
Steering Committee

CHERYL MCCULLUMSMITH, MD, PHD

University of Cincinnati

FERNANDO S. GOES, MD

Johns Hopkins University

MICHAEL THASE, MD

University of Pennsylvania

ANDREW GODDARD, MD

University of California San Francisco