Oral Ketamine in the Treatment of Depression and Anxiety in Patients with Cancer
Study type: Interventional What is this?
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study phase: II What is this?
During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.
- Scottsdale/Phoenix, Arizona: 12-001156
NCT ID: NCT01680172
Sponsor Protocol Number: 12-001156
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.
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.
See eligibility 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 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
- 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
Participating Mayo Clinic locations
Study statuses change often. Please contact us for help.
|Mayo Clinic Location
Mayo Clinic principal investigator
Robert Bright, M.D.
Closed for enrollment
Cancer Center Clinical Trials Referral Office