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

Participant Flow

Recruitment Details	Participants were recruited at Mayo Clinic in Scottsdale, Arizona from 2012 to 2014.
Pre-assignment Details


Arm/Group Title	Ketamine	Placebo
Arm/Group Description	Single dose of ketamine (0.5 mg/kg)...	Single dose of placebo ...
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

Baseline Characteristics

Arm/Group Title		Ketamine	Placebo	Total
Arm/Group Description		Single dose of ketamine (0.5 mg/kg)...	Single dose of placebo ...	Total of all reporting groups
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
Baseline Analysis Population Description		[Not Specified]
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
United States		3	2	5

Outcome Measures

1.Primary Outcome


Title	Hospital Anxiety and Depression Scale - Anxiety Score (HADS-A)
Description	Hospital Anxiety and Depression Scale (HADS) is a fourteen item scale....
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

Outcome Measure Data

Analysis Population Description

Study was terminated early due to slow accrual.


Arm/Group Title	Ketamine	Placebo
Arm/Group Description:	Single dose of ketamine (0.5 mg/kg)...	Single dose of placebo ...
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)
Description	Hospital Anxiety and Depression Scale (HADS) is a fourteen item scale....
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

Outcome Measure Data

Analysis Population Description

Study was terminated early due to slow accrual.


Arm/Group Title	Ketamine	Placebo
Arm/Group Description:	Single dose of ketamine (0.5 mg/kg)...	Single dose of placebo ...
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)

Adverse Events

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
Arm/Group Description	Single dose of ketamine (0.5 mg/kg)...		Single dose of placebo ...
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	--/--		--/--
Serious Adverse Events Serious Adverse Events
	Ketamine		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/3 (0.00%)		0/2 (0.00%)
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

Limitations and Caveats

The study was terminated due to slow accrual rate. Data analysis limited to 5 participants.

More Information

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
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

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