Oral Ketamine in the Treatment of Depression and Anxiety in Patients With Cancer
Ketamine
+ Placebo
Behavior+3
+ Mental Disorders
+ Behavioral Symptoms
Supportive Care Study
Summary
Study start date: August 1, 2012
Actual date on which the first participant was enrolled.Depression is common in patients with cancer. Current antidepressants, while effective, have an onset of action of at least several weeks. Ketamine has emerged as a drug with promise for cancer patients. It has been shown to potentiate opiate analgesic effects. Single dose parenteral and enteral administration studies in medically healthy treatment-resistant depressed patients have shown rapid relief of symptoms. A recent two patient case series reported a rapid and moderately sustained symptom reduction in depression and anxiety in palliative care patients following a single dose of oral ketamine 0.5 mg/kg, with no adverse effects. Benefit was seen as little as 1 hour after the administration and sustained up to 30 days. These case reports generate hypotheses of efficacy for ketamine in the treatment of depression and anxiety in patients with cancer. This study is a randomized, double-blind, placebo-controlled investigation of these hypotheses.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.5 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Supportive Care Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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 Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
ExperimentalGroup II
PlaceboStudy Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 2 locations
Yuma Regional Medical Center
Yuma, United States