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