Clinical TrialDepressive DisordersKetaminePlaceboTerminated

Oral Ketamine in the Treatment of Depression and Anxiety in Patients With Cancer

Randomized, double-blind, placebo-controlled study (n=5) testing a single oral dose of ketamine 0.5 mg/kg versus placebo for depression and anxiety in patients with cancer.

Target Enrollment
5 participants
Study Type
Phase II interventional
Design
Randomized, quadruple Blind

Detailed Description

Ketamine has been reported to produce rapid antidepressant and anxiolytic effects; two case reports described sustained benefit after a single oral 0.5 mg/kg dose in palliative patients. This trial tested that hypothesis in oncology outpatients with clinically significant depressive symptoms.

Randomized, quadruple-blind, parallel-group design comparing a single oral liquid dose of ketamine 0.5 mg/kg to matched placebo in adults with cancer and HADS depression score >11; safety and symptom measures collected acutely and at follow-up.

Study Protocol

Preparation

sessions

Dosing

1 sessions

Integration

sessions

Study Arms & Interventions

Ketamine

experimental

Single oral dose ketamine 0.5 mg/kg (liquid)

Interventions

  • Ketamine0.5 mg/kg
    via Oral• single dose

    10 mg/mL liquid formulation taken orally

Placebo

inactive

Single oral placebo dose

Interventions

  • Placebo
    via Oral• single dose

    Matched liquid placebo

Participants

Ages
18 – 99
Sexes
Male & Female

Inclusion 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

  • 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

Study Details

  • Status
    Terminated
  • Phase
    Phase II
  • Type
    interventional
  • Design
    Randomizedquadruple Blind
  • Target Enrollment5 participants
  • Timeline
    Start: 2012-01-08
    End: 2015-01-02
  • Compounds
    KetaminePlacebo
  • Topic
    Depressive Disorders

Locations

Mayo Clinic in Arizona — Scottsdale, Arizona, United States
Yuma Regional Medical Center — Yuma, Arizona, United States

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