FMRI of Patients Receiving IV Ketamine for Treatment Resistant Bipolar Depression

NCT ID: NCT06620042

Last Updated: 2025-11-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-12
• Study Completion Date: 2025-10-31

Brief Summary

This is a prospective open-label observational study of patients with treatment resistant bipolar depression referred for intravenous ketamine, with an interventional component of fMRI.

Detailed Description

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.

Conditions

Bipolar Depression; Treatment Resistant Bipolar Depression

Keywords

ketamine; bipolar depression; bipolar disorder; bipolar

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Open-label Ketamine TRBD

Outpatients with treatment resistant bipolar depression referred by their clinical providers for intravenous ketamine treatment

Group Type: OTHER

Ketamine

Intervention Type: DRUG

Open-label Ketamine

Functional magnetic resonance imaging (fMRI)

Intervention Type: OTHER

Functional magnetic resonance imaging (fMRI) of the brain

Interventions

Ketamine

Open-label Ketamine

Intervention Type: DRUG

Functional magnetic resonance imaging (fMRI)

Functional magnetic resonance imaging (fMRI) of the brain

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Written informed consent before any study related procedures are performed

2. Males/females at least 18 years of age but no older than 75 years of age

3. Meet DSM-5 criteria for a current Major Depressive Episode and lifetime Bipolar I disorder or Bipolar II disorder as determined by both:

A. a clinician's diagnostic evaluation and B. confirmed with the MINI International Neuropsychiatric Interview (MINI 7.0.2)

4. A current depressive episode that has lasted a minimum of 4 weeks as determined by both:

A. a clinician's diagnostic evaluation and B. confirmed with the MINI International Neuropsychiatric Interview (MINI 7.0.2)

5. Meet all the following criteria on symptom rating scales at screening:

A. Montgomery Asberg Depression Rating Scale (MADRS) score ≥20 B. Young Mania Rating Scale (YMRS) score of ≤ 5 C. QIDS-SR-16 score of ≥ 11

6. Have had ≥ 2 adequate trials of mood stabilizers, antipsychotics (only those FDA approved for bipolar depression), or antidepressants or augmentation strategies during their lifetime. An adequate trial is defined as 4 weeks of medication at the minimum FDA approved dose.

7. In the opinion of the investigator, the patient is willing and able to comply with scheduled visits, treatment plan, and other trial procedures for the duration of the study.

Exclusion Criteria

1. Meet DSM-5 criteria for schizophrenia, schizophreniform disorder, schizoaffective disorder, mental retardation, or pervasive developmental disorder

3. The patient is pregnant or breast feeding

4. The patient has a severe medical illness or severe neurological disorder

5. The patient has a known ketamine allergy or is taking a medication that may significantly interact with ketamine (see Appendix)

6. Diagnosis of psychotic features during the current depressive episode or within the past 6 months

7. Was previously enrolled in the trial

8. Active moderate or severe substance use disorder within the last 3 months (no exclusion for tobacco use disorder of any severity)

9. Current episode of mania/hypomania or mixed episode according to MINI or study clinician

10. MRI contraindications

• Severe head trauma
• Claustrophobia incompatible with scanning
• Cardiac pacemaker
• Implanted cardiac defibrillator
• Aneurysm brain clip
• Inner ear implant
• Prior history as a metal worker and/or certain metallic objects in the body -- must complete MRI screening form and be approved by MRI technologist before each scan
• History of clinically significant vertigo middle ear disorder, or double vision

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Brian Barnett

OTHER

Sponsor Role: lead

Responsible Party

Brian Barnett

Staff Physician

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Brian Barnett, MD

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Locations

Cleveland Clinic Lutheran Hospital

Cleveland, Ohio, United States

Cleveland Clinic Lutheran Hospital

Ohio City, Ohio, United States

Countries

United States

Other Identifiers

23-1345

Identifier Type: -

Identifier Source: org_study_id