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

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01680172
• Other study ID #: 12-001156
• Status: Terminated
• Phase: Phase 2
• First received: September 4, 2012
• Last updated: January 29, 2016
• Start date: August 2012
• Est. completion date: February 2015

Study information

• Verified date: January 2016
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Cancer
• Depression
• Depressive Disorder

Intervention

Drug:
• Ketamine
Single dose (0.5 mg/kg) of liquid ketamine 10mg/mL solution taken by mouth
• Placebo
Single dose of liquid placebo solution taken by mouth

Locations

Country	Name	City	State
United States	Mayo Clinic in Arizona	Scottsdale	Arizona
United States	Yuma Regional Medical Center	Yuma	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Baseline, 120 minutes	No
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.	Baseline, 120 minutes	No