The UTHealth Ketamine Project
Condition: Treatment Resistant Depression; Major Depressive Disorder; Bipolar Disorder
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major; Bipolar Disorder; Depressive Disorder, Treatment-Resistant
Intervention: Ketamine
Intervention description: Ketamine will be infused (slow IV infusions of ketamine (0.5 mg/kg) over 40 minutes) twice weekly over a period of 4 weeks and weekly for the following 4 weeks of the study treatment period (8 weeks total).
Intervention MeSH terms: Ketamine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The primary objective of this study is to determine the effectiveness of serial infusions of
      intravenous (IV) ketamine in adults with treatment resistant depression (TRD).
    

Eligibility criteria:

        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.