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NMDA Receptor Antagonist

Ketamine for Bipolar Depression

Phase 2
Waitlist Available
Led By Brian Barnett, MD
Research Sponsored by Brian Barnett
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Meet DSM-5 criteria for a current Major Depressive Episode and lifetime Bipolar I disorder or Bipolar II disorder as determined by both a clinician's diagnostic evaluation and confirmed with the MINI International Neuropsychiatric Interview (MINI 7.0.2)
A current depressive episode that has lasted a minimum of 4 weeks
Must not have
Ketamine treatment within the past 3 months
Taking a benzodiazepine at a dose equivalent to lorazepam 2 mg/day or higher
Timeline
Screening 3 weeks
Treatment Varies
Follow Up three weeks after treatment initiation
Awards & highlights
No Placebo-Only Group

Summary

"This trial is observing patients with bipolar depression who haven't responded to treatment, and they are being given ketamine intravenously. The study also includes using fMRI to understand the effects of ketamine

Who is the study for?
This trial is for individuals with bipolar depression who haven't improved with standard treatments. Participants will receive intravenous ketamine and undergo brain scans using fMRI. Specific eligibility details are not provided.
What is being tested?
The study observes the effects of IV ketamine on patients with treatment-resistant bipolar depression, while also monitoring changes in their brain activity through functional magnetic resonance imaging (fMRI).
What are the potential side effects?
Ketamine may cause side effects such as disorientation, nausea, increased blood pressure, mood swings, or dissociative experiences during infusion. The fMRI procedure is generally safe but can be uncomfortable due to loud noises and confined space.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with a major depressive episode and bipolar disorder.
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I have been experiencing a depressive episode for at least 4 weeks.
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I have tried at least 2 different mental health medications for 4 weeks each.
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I am between 18 and 75 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have not taken ketamine in the last 3 months.
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I am taking a strong anxiety medication daily.
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I am allergic to ketamine or take medication that interacts with it.
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I have a severe illness or neurological disorder.
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I do not have severe heart, liver, kidney diseases, brain or spinal cord tumors, uncontrolled epilepsy, or glaucoma.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~three weeks after treatment initiation
This trial's timeline: 3 weeks for screening, Varies for treatment, and three weeks after treatment initiation for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Acute Response Changes in Subgenual Cingulate Functional Connectivity
Secondary study objectives
Acute Response Baseline Structural Connectivity
Suicidal Ideation Changes in Subgenual Cingulate Functional Connectivity
Sustained Response Changes in Subgenual Cingulate Functional Connectivity

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Open-label Ketamine TRBDExperimental Treatment2 Interventions
Outpatients with treatment resistant bipolar depression referred by their clinical providers for intravenous ketamine treatment
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ketamine
2011
Completed Phase 4
~1120

Find a Location

Who is running the clinical trial?

Brian BarnettLead Sponsor
The Cleveland ClinicLead Sponsor
1,052 Previous Clinical Trials
1,371,094 Total Patients Enrolled
Brian Barnett, MDPrincipal InvestigatorThe Cleveland Clinic
~13 spots leftby Jul 2025
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