TerminatedPhase 2ketamine
Oral Ketamine in the Treatment of Depression and Anxiety in Patients With Cancer
Sponsored by Mayo Clinic
NCT ID
NCT01680172
Target Enrollment
5 participants
Start Date
2012-08
Est. Completion
2015-02
About This Study
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.
Conditions Studied
Interventions
- •Ketamine
- •Placebo
Eligibility
Age:18 Years - N/A
Healthy Volunteers:No
View full eligibility 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
Study Locations (2)
Mayo Clinic in Arizona
Scottsdale, Arizona, United States
Yuma Regional Medical Center
Yuma, Arizona, United States