Overview

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

Status:
Terminated
Trial end date:
2015-02-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Mayo Clinic
Treatments:
Ketamine
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