The UTHealth Ketamine Project

Thus, in the current study we want to naturalistically explore the antidepressant effects of
serial slow IV infusions (40 minutes) of ketamine at a dose of 0.5 mg/kg, over a treatment
period of 8 weeks in an academic psychiatric hospital. This is a minimal sedation treatment.
The primary outcome measure of this study will be remission estimated based on the severity
of depressive scores. After the 8 weeks of treatment, there will be a four week observational
period. During the observational period, participants will receive treatment as usual and
will be contacted over the phone for follow-up questions regarding their overall health
status, mood and clinical state. They will also complete a neurocognitive task at the end of
the 4 week observational period

Inclusion Criteria:

- patients with major depressive disorder (MDD) or bipolar disorder (BD)

- patients with documented treatment resistant disorder (TRD) (according to Diagnostic
Statistical Manual (DSM-IV TR)), and who have failed (defined as patient does not
reach remission within the 8 week trial of an antidepressant or combination at a
therapeutic dose) of at least two trials of first line evidence-based treatments
and/or electroconvulsive therapy (ECT)

Exclusion Criteria:

- Being younger than 18 of age or older than 65.

- Diagnosed with intellectual disability, e.g. mental retardation (MR),
neurodegenerative diseases, e.g. early-onset neurocognitive disturbances such as
frontotemporal dementia (FTD) or behavioral disorders, e.g. adult onset Attention
Deficit Hyperactivity Disorder (ADHD).

- Diagnosed with bipolar disorder not otherwise specified (BD-NOS) or rapid cycling BD

- Diagnosed with personality disorders (PD).

- Previously or currently diagnosed with psychosis (schizoaffective disorder - SAD) or
schizophrenia - SCZ).

- Current major medical problems that affect brain anatomy, neurochemistry, or function,
e.g., obstructive sleep apnea requiring Continuous Positive Airway Pressure (CPAP),
liver insufficiency, kidney insufficiency, cardiovascular problems, systemic
infections, cancer, auto-immune diseases, and any brain disorder (seizure disorder,
stroke, dementia, degenerative neurologic diseases); history of any brain diseases,
including seizures, stroke, meningitis, encephalitis, dementia, degenerative brain
diseases, and head injury with loss of consciousness for any period of time.

- Diagnosed specifically with a cardiovascular disorders such as Arrhythmias, Chronic
Heart Failure, Myocardial Infarction (MI) or suffering from Chronic Obstructive
Pulmonary Disease (COPD) or asthma. Suffering from uncontrolled hypertension or
diastolic BP over 100. Cardiac clearance prior to enrolling in the study/medical
records from physician will be required per patient's primary care physician (PCP).

- Patients with increased risk of laryngospasm, active upper respiratory infections,
respiratory depression, increased intracranial pressure, hyperthyroidism, or
porphyria.

- Current substance abuse or dependence. Only patients who achieved stable, full
remission for at least 6 months will be included.

- Pregnancy or Breast feeding. All female in reproductive age will undergo pregnancy
tests. Female participants will be required to provide evidence of use of
contraceptives during the course of the study.

- Unable to understand the design and requirements of the study

- Unable to sign the informed consent for any reason

- An assigned responsible adult has provided assent to assist in patient's study
participation. The responsible adult agrees to be present at each study appointment as
well as provide transportation to study appointments for the patient.