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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Supportive Care
Conditions Cancer
Depression
Anxiety
Interventions Drug: Ketamine
Drug: Placebo
Enrollment 5
Recruitment Details Participants were recruited at Mayo Clinic in Scottsdale, Arizona from 2012 to 2014.
Pre-assignment Details  
Arm/Group Title Ketamine Placebo
Hide Arm/Group Description

Single dose of ketamine (0.5 mg/kg)

Ketamine: Single dose of ketamine (0.5 mg/kg)

Single dose of placebo

Placebo: Single dose of placebo

Period Title: Overall Study
Started 3 2
Completed 3 2
Not Completed 0 0
Arm/Group Title Ketamine Placebo Total
Hide Arm/Group Description

Single dose of ketamine (0.5 mg/kg)

Ketamine: Single dose of ketamine (0.5 mg/kg)

Single dose of placebo

Placebo: Single dose of placebo

Total of all reporting groups
Overall Number of Baseline Participants 3 2 5
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 2 participants 5 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
3
 100.0%
0
   0.0%
3
  60.0%
>=65 years
0
   0.0%
2
 100.0%
2
  40.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 2 participants 5 participants
Female
2
  66.7%
1
  50.0%
3
  60.0%
Male
1
  33.3%
1
  50.0%
2
  40.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 3 participants 2 participants 5 participants
3 2 5
1.Primary Outcome
Title Hospital Anxiety and Depression Scale - Anxiety Score (HADS-A)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Study was terminated early due to slow accrual.
Arm/Group Title Ketamine Placebo
Hide Arm/Group Description:

Single dose of ketamine (0.5 mg/kg)

Ketamine: Single dose of ketamine (0.5 mg/kg)

Single dose of placebo

Placebo: Single dose of placebo

Overall Number of Participants Analyzed 3 2
Mean (Standard Deviation)
Unit of Measure: units on a scale
HADS-A score at baseline 12.3  (2.5) 16.5  (4.9)
HADS-A Score at 120 minutes post dose 7.7  (3.8) 11.0  (5.7)
2.Primary Outcome
Title Hospital Anxiety Depression Scale- Depression Score (HADS-D)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Study was terminated early due to slow accrual.
Arm/Group Title Ketamine Placebo
Hide Arm/Group Description:

Single dose of ketamine (0.5 mg/kg)

Ketamine: Single dose of ketamine (0.5 mg/kg)

Single dose of placebo

Placebo: Single dose of placebo

Overall Number of Participants Analyzed 3 2
Mean (Standard Deviation)
Unit of Measure: units on a scale
HADS-D Score at baseline 12.7  (1.5) 14.5  (2.1)
HADS-D Score 120 minutes post dose 11.7  (2.3) 10.5  (3.5)
Time Frame Adverse events were evaluated at baseline, 60 minutes and 120 minutes after study drug administration and Days 2, 7, 14 and 28 after study drug administration.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Ketamine Placebo
Hide Arm/Group Description

Single dose of ketamine (0.5 mg/kg)

Ketamine: Single dose of ketamine (0.5 mg/kg)

Single dose of placebo

Placebo: Single dose of placebo

All-Cause Mortality
Ketamine Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Ketamine Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/3 (0.00%)      0/2 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Ketamine Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/3 (100.00%)      2/2 (100.00%)    
Cardiac disorders     
Rapid Heart Rate   1/3 (33.33%)  1 1/2 (50.00%)  1
Chest Pain   1/3 (33.33%)  1 0/2 (0.00%)  0
Gastrointestinal disorders     
Vomiting   0/3 (0.00%)  0 1/2 (50.00%)  1
General disorders     
Headache   2/3 (66.67%)  2 1/2 (50.00%)  1
Impaired Concentration   0/3 (0.00%)  0 2/2 (100.00%)  2
Drowsiness   2/3 (66.67%)  2 2/2 (100.00%)  2
Dizziness   1/3 (33.33%)  1 1/2 (50.00%)  1
Lightheaded   1/3 (33.33%)  1 1/2 (50.00%)  1
Confusion   1/3 (33.33%)  1 1/2 (50.00%)  1
Disorientation   1/3 (33.33%)  1 1/2 (50.00%)  1
Feeling high   1/3 (33.33%)  1 0/2 (0.00%)  0
Feeling of floating   1/3 (33.33%)  1 0/2 (0.00%)  0
Nervous system disorders     
Tingling sensation on skin   1/3 (33.33%)  1 1/2 (50.00%)  1
Psychiatric disorders     
Impaired judgement   1/3 (33.33%)  1 1/2 (50.00%)  1
Respiratory, thoracic and mediastinal disorders     
Shortness of breath   2/3 (66.67%)  2 2/2 (100.00%)  2
Indicates events were collected by systematic assessment
The study was terminated due to slow accrual rate. Data analysis limited to 5 participants.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Robert Bright, MD
Organization: Mayo Clinic
Phone: 480-301-4853
EMail: bright.robert@mayo.edu
Layout table for additonal information
Responsible Party: Robert P. Bright, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01680172     History of Changes
Other Study ID Numbers: 12-001156
First Submitted: September 4, 2012
First Posted: September 7, 2012
Results First Submitted: January 29, 2016
Results First Posted: February 29, 2016
Last Update Posted: February 29, 2016