Low Dose Intravenous Ketamine in Treatment Resistant Depression Patients
Condition: Treatment Resistant Depression
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Treatment-Resistant
Intervention: Ketamine
Intervention description: Ketamine Hydrochloride Injection
Intervention MeSH terms: Ketamine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: Open-label
Masking: None (Open Label)
Enrollment: 9.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No

Summary:

      The primary goal of the project is to study the effect of Ketamine on cortical
      neurophysiological function in TRD patients. The proposal employs robust and non-invasive
      neurophysiological techniques TMS and EEG to investigate the cortical excitability and
      oscillatory activity in patients with treatment resistant depression.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Be between 18-60 years of age

          -  Meet criteria for Treatment Resistant Depression (defined as two or more unsuccessful
             trials of antidepressants at an adequate dose for at least 4 weeks)

        Exclusion Criteria:

          -  Diagnosed with intellectual disability, eg. Mental retardation, neurodegenerative
             diseases, eg. Early onset neurocognitive disturbances such as frontotemporal dementia
             or behavioral disorders, eg. adult onset Attention Deficit Hyperactivity Disorder,

          -  Diagnosed with Bipolar Disorder (BD),

          -  Diagnosed with personality disorders,

          -  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 Hypertension,
             Arrhythmias, Chronic Heart Failure, Myocardial Infarction (MI) or suffering from
             Chronic Obstructive Pulmonary Disease (COPD) or asthma. Cardiac clearance prior to
             enrolling in the study and medical records from physician will be required per
             patient's Primary Care Physician.

          -  Patients with increased risk of laryngospasm, active upper respiratory infections,
             respiratory depression, increased intracranial pressure, thyroid disease, 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.