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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.

NCT03156504 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2022-03-15

Study results available
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Summary

The purpose of this research study is to find out if the medication known as ketamine can help the symptoms of depression. This drug is approved by the Food and Drug Administration (FDA) but the investigators will use it for a non-FDA approved reason (depression).

Conditions

Interventions

DRUG

Ketamine Hydrochloride

Subjects will receive three IV ketamine infusions at 0.5 mg/kg, infused over 100 minutes.

Sponsors & Collaborators

  • National Network of Depression Centers

    collaborator OTHER

  • Mayo Clinic

    lead OTHER

Principal Investigators

  • Mark A Frye, MD · Mayo Clinic

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-01
Primary Completion
2020-02-12
Completion
2020-03-12
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03156504 on ClinicalTrials.gov