Oral Ketamine in the Treatment of Depression and Anxiety in Patients With Advanced-Stage Cancer
18 Years
N/A
Both
Advanced Cancer
Trial Information
Oral Ketamine in the Treatment of Depression and Anxiety in Patients With Advanced-Stage Cancer
Depression is common in patients with advanced cancer. Current antidepressants, while
effective, have an onset of action of at least several weeks. Ketamine has emerged as a
drug with promise for cancer patients. It has been shown to potentiate opiate analgesic
effects. Single dose parenteral and enteral administration studies in medically healthy
treatment-resistant depressed patients have shown rapid relief of symptoms. A recent two
patient case series reported a rapid and moderately sustained symptom reduction in
depression and anxiety in palliative care patients following a single dose of oral ketamine
0.5 mg/kg, with no adverse effects. Benefit was seen as little as 1 hour after the
administration and sustained up to 30 days. These case reports generate hypotheses of
efficacy for ketamine in the treatment of depression and anxiety in patients with advanced
cancer. This study is a randomized, double-blind, placebo-controlled investigation of these
hypotheses.
Inclusion Criteria:
- Patients with advanced-stage 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 solid tumor malignancy
- Depression score of >11 on the 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care
Outcome Measure:
Hospital Anxiety and Depression Scale - Depression Score (HADS-D)
Outcome Description:
Depression score of the Hospital Anxiety and Depression Scale
Outcome Time Frame:
120 minutes
Safety Issue:
No
Principal Investigator
Robert P. Bright, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Mayo Clinic
Authority:
United States: Institutional Review Board
Study ID:
12-001156
NCT ID:
NCT01680172
Start Date:
August 2012
Completion Date:
January 2014
Related Keywords:
- Advanced Cancer
- palliative care
- Depression
- Depressive Disorder
- Neoplasms
Name | Location |
|---|---|
| Mayo Clinic in Arizona | Scottsdale, Arizona 85259-5404 |
