Using ketamine and fMRI to treat bipolar depression
Functional Magnetic Resonance Imaging of Patients Receiving Intravenous Ketamine for Treatment Resistant Bipolar Depression
PHASE2 · The Cleveland Clinic · NCT06620042
This study is testing if ketamine infusions can help people with bipolar depression who haven't found relief from other treatments, while also looking at changes in brain activity.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | The Cleveland Clinic (other) |
| Locations | 2 sites (Cleveland, Ohio and 1 other locations) |
| Trial ID | NCT06620042 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of intravenous ketamine on patients with treatment-resistant bipolar depression through a prospective open-label observational approach. Participants will receive ketamine infusions twice weekly for three weeks, with their response measured using the QIDS-SR-16 score. Functional magnetic resonance imaging (fMRI) will be conducted before the first infusion and after the treatment series to assess brain activity changes. Non-responders will conclude their participation after the acute series, while responders will continue with weekly infusions for an additional three weeks.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with a diagnosis of bipolar I or II disorder experiencing a major depressive episode that has not responded to previous treatments.
Not a fit: Patients who do not meet the criteria for treatment-resistant bipolar depression or those with a current manic episode may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a novel treatment option for patients suffering from treatment-resistant bipolar depression.
How similar studies have performed: Previous studies have shown promising results with ketamine for treatment-resistant depression, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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
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
Where this trial is running
Cleveland, Ohio and 1 other locations
- Cleveland Clinic Lutheran Hospital — Cleveland, Ohio, United States (NOT_YET_RECRUITING)
- Cleveland Clinic Lutheran Hospital — Ohio City, Ohio, United States (RECRUITING)
Study contacts
- Principal investigator: Brian Barnett, MD — The Cleveland Clinic
- Study coordinator: Katelyn Schwesinger, RN
- Email: psychresearch@ccf.org
- Phone: 216 425 7426
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Bipolar Depression, Treatment Resistant Bipolar Depression, ketamine, bipolar depression, bipolar disorder, bipolar