FMRI of Patients Receiving IV Ketamine for Treatment Resistant Bipolar Depression

This open-label observational trial (n=20) will investigate the effects of intravenous ketamine on treatment-resistant bipolar depression, with an interventional component of functional magnetic resonance imaging (fMRI).

The study, conducted by Brian Barnett at The Cleveland Clinic, aims to assess changes in brain connectivity following ketamine treatment.

Participants will receive ketamine infusions twice weekly for three weeks. Responders—those experiencing a ≥50% reduction in depression severity (QIDS-SR-16 score)—will undergo an additional three weeks of weekly ketamine infusions. fMRI scans will be performed before the first infusion and after the initial treatment phase to evaluate neurobiological changes. The study is expected to complete enrolment by December 2025.

Topic Depression Treatment-Resistant Depression Bipolar Disorder Neuroscience
Compound Ketamine
Country United States of America
Visit trial
Status Recruiting
Results Published No
Start date 12 November 2024
End date 01 December 2025
Phase Phase II
Design Open
Type Observational
Generation First
Participants 20
Sex All
Age 18- 75
Therapy No

Trial Details

This is a prospective open-label observational study of patients with treatment resistant bipolar depression referred for intravenous ketamine. All participants will receive an acute series of ketamine consisting of twice weekly infusions over three weeks. Non-responders will have their End of Study visits within 5 days of the last ketamine infusion. Responders (participants who achieve a greater than or equal to 50% decrease on their QIDS-SR-16 score from Baseline) will return for three weeks of continuation treatment (weekly ketamine) and then have their End of Study visit within 5 days of the last continuation treatment. All participants will undergo fMRI the prior to their first ketamine infusion, and after completion of their acute series.

Trial Number NCT06620042

Sponsors & Collaborators

The Cleveland Clinic
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Data attribution

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