Clinical Trials

IRB Study Number 23-1345

Status Recruiting

Phase Not Applicable

Location Lutheran Hospital

Institute Neurological Institute

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 ≥ 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, after their first ketamine infusion, and after completion of their acute series.

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
5. Meet all the following criteria on symptom rating scales at screening: a). Montgomery Asberg Depression Rating Scale (MADRS) score ≥ 20 and b). Young Mania Rating Scale (YMRS) of ≤ 5
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.

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, 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
6. Diagnosis of psychotic features during the current depressive episode or within the last 6 months
7. Was previously enrolled in the trial
8. Active substance use disorder within the last 3 month
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