Oral Ketamine in the Treatment of Depression and Anxiety in Patients With Cancer
Condition: Cancer; Depression; Anxiety
MeSH terms: Depression; Depressive Disorder; Anxiety Disorders
Intervention: Ketamine; Placebo
Intervention description: Single dose (0.5 mg/kg) of liquid ketamine 10mg/mL solution taken by mouth; Single dose of liquid placebo solution taken by mouth
Intervention MeSH terms: Ketamine
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 5.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: cancer; depression; anxiety; palliative care

Summary:

      Depression is common in patients with cancer. Current medications for depression, while
      effective, take several weeks to take effect. Ketamine has emerged as a drug with promise for
      cancer patients. In two reported cases, a single dose of ketamine induced rapid and
      moderately sustained symptom reduction in depression and anxiety with no adverse side
      effects. Benefit was seen in as little as 1 hour and sustained up to 30 days. This study is a
      randomized, double-blind, placebo-controlled investigation testing whether a single dose of
      ketamine improves depression and anxiety relative to placebo in patients with cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with cancer

          -  Outpatient status at the time of study entry

          -  18 years of age or older

          -  Life expectancy of at least 1 month

          -  Regular access to a telephone (for safety reasons)

          -  Reliable transportation to follow-up visits

          -  Caregiver observation available for 24 hours after the dose

          -  Histologically-proven malignancy

          -  Depression score of >11 on the Hospital Anxiety and Depression Scale (HADS)

          -  Provision of informed consent

          -  Able to complete the patient questionnaires alone or with assistance

          -  Able to speak and read English

          -  May receive other psycho-active medications while on the study i.e. opiates, except as
             defined within the exclusion criteria

          -  May receive psychotherapy from an outside provider at the beginning and/or during the
             course of the study

        Exclusion Criteria:

          -  Obvious cognitive dysfunction or Mini Mental Status Exam score <20

          -  Antidepressants started or dose changed within 8 weeks of the beginning of the study
             or during the study

          -  Benzodiazepines prescribed for psychiatric indications that have been started or dose
             change within 2 weeks of the beginning of study enrollment

          -  Suicidal ideation or a suicide attempt within the last year

          -  Patients with current or past psychosis not from delirium

          -  Females who are pregnant or nursing

          -  Unable to take oral medications

          -  Primary or metastatic brain malignancy

          -  Gastrointestinal tract obstruction

          -  Prior adverse reaction to or other contraindication to ketamine

          -  Substance abuse or dependence, as defined by Diagnostic and Statistical Manual of
             Mental Disorders-IV (DSM-IV) criteria, within the last 90 days