Clinical TrialBipolar DisorderKetamineCompleted

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).

Target Enrollment
20 participants
Study Type
Phase II observational
Design
Non-randomized

Detailed Description

Prospective open-label, single-group observational study of IV ketamine for treatment-resistant bipolar depression. All participants receive an acute series of ketamine infusions twice weekly for three weeks; responders may continue weekly infusions for three additional weeks.

Functional MRI is performed prior to the first infusion and after completion of the acute series to assess neural correlates of treatment response. Responders are defined as >=50% decrease on QIDS-SR-16 from baseline.

Study Protocol

Preparation

sessions

Dosing

6 sessions

Integration

sessions

Study Arms & Interventions

Open-label Ketamine

experimental

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

Interventions

  • Ketamine
    via IV• twice weekly (acute); weekly (continuation)• 9 doses total

    Open-label IV ketamine infusions: twice weekly for 3 weeks (acute, 6 infusions); responders may receive weekly continuation x3.

  • Compound
    via Other• pre/post assessments

    Functional magnetic resonance imaging (fMRI) performed prior to first infusion and after completion of acute series.

Participants

Ages
18 – 75
Sexes
Male & Female

Inclusion 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 clinician's diagnostic evaluation and 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 clinician's diagnostic evaluation and confirmed with the MINI 7.0.2
  • 5. Meet all the following criteria on symptom rating scales at screening: MADRS score >=20; YMRS score <=5; QIDS-SR-16 score >=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

  • Exclusion Criteria:
  • 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)

Study Details

  • Status
    Completed
  • Phase
    Phase II
  • Type
    observational
  • Design
    Non-randomized
  • Target Enrollment20 participants
  • Timeline
    Start: 2024-11-12
    End: 2025-12-01
  • Compound
    Ketamine
  • Topic
    Bipolar Disorder

Locations

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

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