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

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ClinicalTrials.gov Identifier: NCT01680172
Recruitment Status : Terminated (Slow enrollment)
First Posted : September 7, 2012
Results First Posted : February 29, 2016
Last Update Posted : February 29, 2016
Sponsor:
Information provided by (Responsible Party):
Robert P. Bright, Mayo Clinic

Tracking Information
First Submitted Date  ICMJE September 4, 2012
First Posted Date  ICMJE September 7, 2012
Results First Submitted Date  ICMJE January 29, 2016
Results First Posted Date  ICMJE February 29, 2016
Last Update Posted Date February 29, 2016
Study Start Date  ICMJE August 2012
Actual Primary Completion Date February 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 29, 2016)
  • Hospital Anxiety and Depression Scale - Anxiety Score (HADS-A) [ Time Frame: 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) [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 6, 2012)
  • HADS-D [ Time Frame: 120 minutes ]
    Depression score of the Hospital Anxiety and Depression Scale
  • HADS-A [ Time Frame: 120 minutes ]
    Anxiety score of the Hospital Anxiety and Depression Scale
Change History Complete list of historical versions of study NCT01680172 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Oral Ketamine in the Treatment of Depression and Anxiety in Patients With Cancer
Official Title  ICMJE Oral Ketamine in the Treatment of Depression and Anxiety in Patients With Cancer
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Cancer
  • Depression
  • Anxiety
Intervention  ICMJE
  • Drug: Ketamine
    Single dose (0.5 mg/kg) of liquid ketamine 10mg/mL solution taken by mouth
    Other Name: Ketalar
  • Drug: Placebo
    Single dose of liquid placebo solution taken by mouth
Study Arms  ICMJE
  • Experimental: Ketamine
    Single dose of ketamine (0.5 mg/kg)
    Intervention: Drug: Ketamine
  • Placebo Comparator: Placebo
    Single dose of placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: January 29, 2016)
5
Original Estimated Enrollment  ICMJE
 (submitted: September 6, 2012)
68
Actual Study Completion Date  ICMJE February 2015
Actual Primary Completion Date February 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01680172
Other Study ID Numbers  ICMJE 12-001156
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Robert P. Bright, Mayo Clinic
Study Sponsor  ICMJE Mayo Clinic
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Robert P. Bright, MD Mayo Clinic
PRS Account Mayo Clinic
Verification Date January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP