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NCT03156504 · ClinicalTrials.gov registry record · Phase 4
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.
A Phase 4 study of Major Depression and Bipolar I Disorder, sponsored by Mayo Clinic.
- Completed
- Registry status
- Phase 4
- Development phase
- 75
- Enrollment target
- 4
- Study locations
NCT03156504: Completed Phase 4 study of Major Depression and Bipolar I Disorder, sponsored by Mayo Clinic.
NCT03156504 is a Phase 4 study of Major Depression and Bipolar I Disorder that has completed, run by Mayo Clinic. The registered enrollment target is 75 participants, below the 325-participant average among 28 other Major Depression trials with a reported enrollment target (77% lower). The trial reports 4 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03156504, a Phase 4 study of Major Depression and Bipolar I Disorder, has completed, sponsored by Mayo Clinic.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 75 participants
- Enrollment target
- 4
- Study locations
Study 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).
Primary Outcome
Total number of subjects with ≤ 9 MADRS score 24 hours post Ketamine infusion #3. The Montgomery Åsberg Depression Scale (MÅDRS) is a 10-item observer rating scale assessing symptoms of depression. The score ranges from 0 (no depression) to 60 (very depressed). For this study a score of less than or equal to 9 was considered clinical remission of depression.
Conditions Studied
Interventions
- DRUG Ketamine Hydrochloride
Study Locations (4)
Maryland
- Johns Hopkins Hospital - Baltimore
Michigan
- University of Michigan - Ann Arbor
Minnesota
- Mayo Clinic - Rochester
Ohio
- University of Cincinnati Medical Center - Cincinnati
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 75 participants |
| Start Date | 2017-06-01 |
| Est. Completion | 2020-03-12 |
| Phase | Phase 4 |
What the finished NCT03156504 record still lists
NCT03156504 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 75 participants, a relatively small participant target, below the 325-participant average among 28 other Major Depression trials with a reported enrollment target (77% lower).
The record links to 4 conditions, with Major Depression appearing as the primary indexed condition, and to 1 intervention - of which Ketamine Hydrochloride is the first listed.
NCT03156504 reports a single indexed study location in Maryland, Michigan, Minnesota.
Frequently Asked Questions
What is clinical trial NCT03156504 about?
NCT03156504 is a clinical study titled "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.". 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).
What is the current status of trial NCT03156504?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 75 participants. The study started on 2017-06-01. Estimated completion is 2020-03-12.
What conditions does trial NCT03156504 study?
This clinical trial studies the following conditions: Major Depression, Bipolar I Disorder, Bipolar II Disorder, Unipolar Depression.
What interventions are being tested in trial NCT03156504?
The interventions under investigation include: Ketamine Hydrochloride (DRUG).
Who is sponsoring clinical trial NCT03156504?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03156504 being conducted?
This trial has 4 study locations across Maryland, Michigan, Minnesota, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Major Depression
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03156504's enrollment target sits among peer trials
75 16th of 28 higher than 12 of 28 other Major Depression trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Major Depression trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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