Trial Outcomes & Findings for Oral Ketamine in the Treatment of Depression and Anxiety in Patients With Cancer (NCT NCT01680172)

Last Updated: 2016-02-29

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

5 participants

Primary outcome timeframe

Baseline, 120 minutes

Results posted on

2016-02-29

Participant Flow

Participants were recruited at Mayo Clinic in Scottsdale, Arizona from 2012 to 2014.

Participant milestones

Participant milestones
Measure	Ketamine Single dose of ketamine (0.5 mg/kg) Ketamine: Single dose of ketamine (0.5 mg/kg)	Placebo Single dose of placebo Placebo: Single dose of placebo
Overall Study STARTED	3	2
Overall Study COMPLETED	3	2
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ketamine n=3 Participants Single dose of ketamine (0.5 mg/kg) Ketamine: Single dose of ketamine (0.5 mg/kg)	Placebo n=2 Participants Single dose of placebo Placebo: Single dose of placebo	Total n=5 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment United States	3 participants n=5 Participants	2 participants n=7 Participants	5 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 120 minutes

Population: Study was terminated early due to slow accrual.

Outcome measures

Outcome measures
Measure	Ketamine n=3 Participants Single dose of ketamine (0.5 mg/kg) Ketamine: Single dose of ketamine (0.5 mg/kg)	Placebo n=2 Participants Single dose of placebo Placebo: Single dose of placebo
Hospital Anxiety and Depression Scale - Anxiety Score (HADS-A) HADS-A score at baseline	12.3 units on a scale Standard Deviation 2.5	16.5 units on a scale Standard Deviation 4.9
Hospital Anxiety and Depression Scale - Anxiety Score (HADS-A) HADS-A Score at 120 minutes post dose	7.7 units on a scale Standard Deviation 3.8	11.0 units on a scale Standard Deviation 5.7

PRIMARY outcome

Timeframe: Baseline, 120 minutes

Population: Study was terminated early due to slow accrual.

Outcome measures

Outcome measures
Measure	Ketamine n=3 Participants Single dose of ketamine (0.5 mg/kg) Ketamine: Single dose of ketamine (0.5 mg/kg)	Placebo n=2 Participants Single dose of placebo Placebo: Single dose of placebo
Hospital Anxiety Depression Scale- Depression Score (HADS-D) HADS-D Score at baseline	12.7 units on a scale Standard Deviation 1.5	14.5 units on a scale Standard Deviation 2.1
Hospital Anxiety Depression Scale- Depression Score (HADS-D) HADS-D Score 120 minutes post dose	11.7 units on a scale Standard Deviation 2.3	10.5 units on a scale Standard Deviation 3.5

Adverse Events

Ketamine

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Robert Bright, MD

Mayo Clinic

Phone: 480-301-4853

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Ketamine n=3 participants at risk Single dose of ketamine (0.5 mg/kg) Ketamine: Single dose of ketamine (0.5 mg/kg)	Placebo n=2 participants at risk Single dose of placebo Placebo: Single dose of placebo
Cardiac disorders Rapid Heart Rate	33.3% 1/3 • Number of events 1 • 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.	50.0% 1/2 • Number of events 1 • 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.
General disorders Headache	66.7% 2/3 • Number of events 2 • 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.	50.0% 1/2 • Number of events 1 • 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.
General disorders Impaired Concentration	0.00% 0/3 • 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.	100.0% 2/2 • Number of events 2 • 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.
Gastrointestinal disorders Vomiting	0.00% 0/3 • 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.	50.0% 1/2 • Number of events 1 • 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.
Cardiac disorders Chest Pain	33.3% 1/3 • Number of events 1 • 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.	0.00% 0/2 • 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.
Respiratory, thoracic and mediastinal disorders Shortness of breath	66.7% 2/3 • Number of events 2 • 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.	100.0% 2/2 • Number of events 2 • 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.
General disorders Drowsiness	66.7% 2/3 • Number of events 2 • 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.	100.0% 2/2 • Number of events 2 • 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.
General disorders Dizziness	33.3% 1/3 • Number of events 1 • 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.	50.0% 1/2 • Number of events 1 • 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.
General disorders Lightheaded	33.3% 1/3 • Number of events 1 • 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.	50.0% 1/2 • Number of events 1 • 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.
General disorders Confusion	33.3% 1/3 • Number of events 1 • 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.	50.0% 1/2 • Number of events 1 • 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.
General disorders Disorientation	33.3% 1/3 • Number of events 1 • 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.	50.0% 1/2 • Number of events 1 • 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.
General disorders Feeling high	33.3% 1/3 • Number of events 1 • 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.	0.00% 0/2 • 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.
General disorders Feeling of floating	33.3% 1/3 • Number of events 1 • 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.	0.00% 0/2 • 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.
Nervous system disorders Tingling sensation on skin	33.3% 1/3 • Number of events 1 • 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.	50.0% 1/2 • Number of events 1 • 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.
Psychiatric disorders Impaired judgement	33.3% 1/3 • Number of events 1 • 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.	50.0% 1/2 • Number of events 1 • 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.