Oral Ketamine in the Treatment of Depression and Anxiety in Patients With Cancer
Stopped early · Phase 2 · Has a placebo group
Conditions studied: Cancer, Depression, Anxiety
In brief
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.
Key facts
- Study ID
- NCT01680172
- Run by
- Mayo Clinic
- People needed
- 5
- Starts
- 2012-08-01
- Expected to finish
- 2015-02-01
- Last updated by the study team
- 2016-02-29
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Mayo Clinic in Arizona — Scottsdale, Arizona, United States
- Yuma Regional Medical Center — Yuma, Arizona, United States
Full record on ClinicalTrials.gov
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