CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 75 enrolled
Drug / intervention
Ketamine Hydrochloridedrug
Likely dose
Ketamine Hydrochloride 0.5 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03156504
NCT03156504Phase 4Completed
CompareCT.gov

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.

Mayo Clinic·interventional·Posted May 17, 2017·Updated Mar 15, 2022

In Brief

A Phase 4 clinical trial evaluating Ketamine Hydrochloride for Major Depression and 3 related conditions. Completed, enrolled 75 participants across 4 sites.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMajor Depression, Bipolar I Disorder, Bipolar II Disorder, Unipolar Depression
CountriesUnited States
CollaboratorsNational Network of Depression Centers

Timeline

Phase 4CompletedFinished
201820192020202120222023202420252026
First PostedMay 17, 2017
Enrollment StartJun 1, 2017
Primary CompletionFeb 12, 2020
Study CompletionMar 12, 2020
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 9.1 years ago

Interventions

Ketamine Hydrochloridedrug

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