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

This study is currently recruiting participants.
Verified February 2013 by Mayo Clinic
Sponsor:
Information provided by (Responsible Party):
Robert P. Bright, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01680172
First received: September 4, 2012
Last updated: February 1, 2013
Last verified: February 2013
History of Changes
  Purpose

Depression is common in patients with advanced 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 advanced cancer.


Condition Intervention Phase
Advanced Cancer
 Drug: Ketamine
Drug: Placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Oral Ketamine in the Treatment of Depression and Anxiety in Patients With Advanced-Stage Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Hospital Anxiety and Depression Scale - Depression Score (HADS-D) [ Time Frame: 120 minutes ] [ Designated as safety issue: No ]
    Depression score of the Hospital Anxiety and Depression Scale

  • Hospital Anxiety and Depression Scale - Anxiety Score (HADS-A) [ Time Frame: 120 minutes ] [ Designated as safety issue: No ]
    Anxiety score of the Hospital Anxiety and Depression Scale


Estimated Enrollment: 68
Study Start Date: August 2012
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ketamine
Single dose of ketamine (0.5 mg/kg)
 Drug: Ketamine
Single dose of ketamine (0.5 mg/kg)
Placebo Comparator: Placebo
Single dose of placebo
 Drug: Placebo
Single dose of placebo

Detailed Description:

Depression is common in patients with advanced 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 advanced cancer. This study is a randomized, double-blind, placebo-controlled investigation of these hypotheses.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with advanced-stage 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 solid tumor 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01680172

Contacts
Contact: Anne Bosworth 480-301-4058 bosworth.anne@mayo.edu

Locations
United States, Arizona
Mayo Clinic in Arizona Recruiting
Scottsdale, Arizona, United States, 85259
Principal Investigator: Robert P. Bright, MD            
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Robert P. Bright, MD Mayo Clinic
  More Information

No publications provided

Responsible Party: Robert P. Bright, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01680172     History of Changes
Other Study ID Numbers: 12-001156
Study First Received: September 4, 2012
Last Updated: February 1, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
palliative care

Additional relevant MeSH terms:
Depression
Depressive Disorder
Neoplasms
Behavioral Symptoms
Mood Disorders
Mental Disorders
Ketamine
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
 Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on May 16, 2013