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

Overview

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.

Participation eligibility

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. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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 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

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location	Status	Contact
Scottsdale/Phoenix, Ariz. Mayo Clinic principal investigator Robert Bright, M.D.	Closed for enrollment	Contact information: Cancer Center Clinical Trials Referral Office 855-776-0015

Mayo Clinic Location

Status

Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Robert Bright, M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

More information

Publications

Publications are currently not available

Clinical Trials