COMPLETED

FMRI of Patients Receiving IV Ketamine for Treatment Resistant Bipolar Depression

Conditions

Bipolar Depression Treatment Resistant Bipolar Depression ketamine bipolar disorder bipolar

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Functional Magnetic Resonance Imaging of Patients Receiving Intravenous Ketamine for Treatment Resistant Bipolar Depression

Quick Facts

Study Start:2024-11-12

Study Completion:2025-10-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT06620042

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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: 4. A current depressive episode that has lasted a minimum of 4 weeks as determined by both: 5. Meet all the following criteria on symptom rating scales at screening: 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.	1. Meet DSM-5 criteria for schizophrenia, schizophreniform disorder, schizoaffective disorder, mental retardation, or pervasive developmental disorder 2. Meets any exclusion criteria for ketamine treatment (uncontrolled arterial hypertension, uncontrolled hyperthyroidism, severe ischemic heart disease or heart failure, severe liver or kidney disease, space occupying lesion in the brain or the spinal cord, and uncontrolled glaucoma) 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

Inclusion Criteria

Exclusion 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:
4. A current depressive episode that has lasted a minimum of 4 weeks as determined by both:
5. Meet all the following criteria on symptom rating scales at screening:
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.

1. Meet DSM-5 criteria for schizophrenia, schizophreniform disorder, schizoaffective disorder, mental retardation, or pervasive developmental disorder
2. Meets any exclusion criteria for ketamine treatment (uncontrolled arterial hypertension, uncontrolled hyperthyroidism, severe ischemic heart disease or heart failure, severe liver or kidney disease, space occupying lesion in the brain or the spinal cord, and uncontrolled glaucoma)
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

Contacts and Locations

Principal Investigator

Brian Barnett, MD

PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Study Locations (Sites)

Cleveland Clinic Lutheran Hospital

Cleveland, Ohio, 44113

United States

Cleveland Clinic Lutheran Hospital

Ohio City, Ohio, 44113

United States

Collaborators and Investigators

Sponsor: Brian Barnett

Brian Barnett, MD, PRINCIPAL_INVESTIGATOR, The Cleveland Clinic

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-11-12

Study Completion Date2025-10-31

Study Record Updates

Study Start Date2024-11-12

Study Completion Date2025-10-31

Terms related to this study

Keywords Provided by Researchers

ketamine
bipolar depression
bipolar disorder
bipolar

Additional Relevant MeSH Terms

Bipolar Depression
Treatment Resistant Bipolar Depression