Anxiety, Cancer, Depression
Conditions
Keywords
cancer, depression, anxiety, palliative care
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.
Interventions
DRUGKetamine
Single dose (0.5 mg/kg) of liquid ketamine 10mg/mL solution taken by mouth
DRUGPlacebo
Single dose of liquid placebo solution taken by mouth
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hospital Anxiety and Depression Scale - Anxiety Score (HADS-A) | Baseline, 120 minutes | 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) | Baseline, 120 minutes | 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. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited at Mayo Clinic in Scottsdale, Arizona from 2012 to 2014.
Participants by arm
| Arm | Count |
|---|---|
| Ketamine Single dose of ketamine (0.5 mg/kg)
Ketamine: Single dose of ketamine (0.5 mg/kg) | 3 |
| Placebo Single dose of placebo
Placebo: Single dose of placebo | 2 |
| Total | 5 |
Baseline characteristics
| Characteristic | Ketamine | Placebo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 2 Participants | 2 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants | 0 Participants | 3 Participants |
| Region of Enrollment United States | 3 participants | 2 participants | 5 participants |
| Sex: Female, Male Female | 2 Participants | 1 Participants | 3 Participants |
| Sex: Female, Male Male | 1 Participants | 1 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 3 / 3 | 2 / 2 |
| serious Total, serious adverse events | 0 / 3 | 0 / 2 |
Outcome results
Primary
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.
Time frame: Baseline, 120 minutes
Population: Study was terminated early due to slow accrual.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ketamine | Hospital Anxiety and Depression Scale - Anxiety Score (HADS-A) | HADS-A score at baseline | 12.3 units on a scale | Standard Deviation 2.5 |
| Ketamine | Hospital Anxiety and Depression Scale - Anxiety Score (HADS-A) | HADS-A Score at 120 minutes post dose | 7.7 units on a scale | Standard Deviation 3.8 |
| Placebo | Hospital Anxiety and Depression Scale - Anxiety Score (HADS-A) | HADS-A Score at 120 minutes post dose | 11.0 units on a scale | Standard Deviation 5.7 |
| Placebo | Hospital Anxiety and Depression Scale - Anxiety Score (HADS-A) | HADS-A score at baseline | 16.5 units on a scale | Standard Deviation 4.9 |
Primary
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.
Time frame: Baseline, 120 minutes
Population: Study was terminated early due to slow accrual.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ketamine | Hospital Anxiety Depression Scale- Depression Score (HADS-D) | HADS-D Score at baseline | 12.7 units on a scale | Standard Deviation 1.5 |
| Ketamine | Hospital Anxiety Depression Scale- Depression Score (HADS-D) | HADS-D Score 120 minutes post dose | 11.7 units on a scale | Standard Deviation 2.3 |
| Placebo | Hospital Anxiety Depression Scale- Depression Score (HADS-D) | HADS-D Score at baseline | 14.5 units on a scale | Standard Deviation 2.1 |
| Placebo | Hospital Anxiety Depression Scale- Depression Score (HADS-D) | HADS-D Score 120 minutes post dose | 10.5 units on a scale | Standard Deviation 3.5 |