Back to resultsOral Ketamine in the Treatment of Depression and Anxiety in Patients With Cancer
Primary Purpose
Cancer, Depression, Anxiety
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Ketamine
Placebo
Sponsored by
About this trial
This is an interventional supportive care trial for Cancer focused on measuring cancer, depression, anxiety, palliative care
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
Sites / Locations
- Mayo Clinic in Arizona
- Yuma Regional Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Ketamine
Placebo
Arm Description
Single dose of ketamine (0.5 mg/kg)
Single dose of placebo
Outcomes
Primary Outcome Measures
Hospital Anxiety and Depression Scale - Anxiety Score (HADS-A)
Hospital Anxiety and Depression Scale (HADS) is a fourteen item scale. Seven of the items relate to anxiety and seven relate to depression. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 (no symptoms) and 21 (severe symptoms) for either anxiety or depression. Cut-offs for identifying psychiatric distress has been reported in the literature to be >10 for anxiety and >8 for depression.
Hospital Anxiety Depression Scale- Depression Score (HADS-D)
Hospital Anxiety and Depression Scale (HADS) is a fourteen item scale. Seven of the items relate to anxiety and seven relate to depression. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 (no symptoms) and 21 (severe symptoms) for either anxiety or depression. Cut-offs for identifying psychiatric distress has been reported in the literature to be >10 for anxiety and >8 for depression.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01680172
Brief Title
Oral Ketamine in the Treatment of Depression and Anxiety in Patients With Cancer
Official Title
Oral Ketamine in the Treatment of Depression and Anxiety in Patients With Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Terminated
Why Stopped
Slow enrollment
Study Start Date
August 2012 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
February 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer, Depression, Anxiety
Keywords
cancer, depression, anxiety, palliative care
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ketamine
Arm Type
Experimental
Arm Description
Single dose of ketamine (0.5 mg/kg)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Single dose of placebo
Intervention Type
Drug
Intervention Name(s)
Ketamine
Other Intervention Name(s)
Ketalar
Intervention Description
Single dose (0.5 mg/kg) of liquid ketamine 10mg/mL solution taken by mouth
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Single dose of liquid placebo solution taken by mouth
Primary Outcome Measure Information:
Title
Hospital Anxiety and Depression Scale - Anxiety Score (HADS-A)
Description
Hospital Anxiety and Depression Scale (HADS) is a fourteen item scale. Seven of the items relate to anxiety and seven relate to depression. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 (no symptoms) and 21 (severe symptoms) for either anxiety or depression. Cut-offs for identifying psychiatric distress has been reported in the literature to be >10 for anxiety and >8 for depression.
Time Frame
Baseline, 120 minutes
Title
Hospital Anxiety Depression Scale- Depression Score (HADS-D)
Description
Hospital Anxiety and Depression Scale (HADS) is a fourteen item scale. Seven of the items relate to anxiety and seven relate to depression. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 (no symptoms) and 21 (severe symptoms) for either anxiety or depression. Cut-offs for identifying psychiatric distress has been reported in the literature to be >10 for anxiety and >8 for depression.
Time Frame
Baseline, 120 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert P. Bright, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Arizona
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Facility Name
Yuma Regional Medical Center
City
Yuma
State/Province
Arizona
ZIP/Postal Code
85364
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Oral Ketamine in the Treatment of Depression and Anxiety in Patients With Cancer
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