RECRUITING

FMRI of Patients Receiving IV Ketamine for Treatment Resistant Bipolar Depression

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.

Study Overview

Study Details

Study overview

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.

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

FMRI of Patients Receiving IV Ketamine for Treatment Resistant Bipolar Depression

Condition
Bipolar Depression
Intervention / Treatment

-

Contacts and Locations

Cleveland

Cleveland Clinic Lutheran Hospital, Cleveland, Ohio, United States, 44113

Ohio City

Cleveland Clinic Lutheran Hospital, Ohio City, Ohio, United States, 44113

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • 5. Meet all the following criteria on symptom rating scales at screening:
  • 6. Have had ≥ 2 adequate trials of mood stabilizers, antipsychotics, 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, uncontrolled epilepsy 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 substance use disorder within the last 3 months
  • 9. Current episode of mania/hypomania or mixed episode according to MINI or study clinician
  • 10. Taking a benzodiazepine at a dose equivalent to lorazepam 2 mg/day or higher
  • 11. Ketamine treatment within the past 3 months
  • 12. 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, seizure disorder, middle ear disorder, or double vision

Ages Eligible for Study

18 Years to 75 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Brian Barnett,

Brian Barnett, MD, PRINCIPAL_INVESTIGATOR, The Cleveland Clinic

Study Record Dates

2025-12-01