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

This study has been terminated.
(Slow enrollment)
Sponsor:
Information provided by (Responsible Party):
Robert P. Bright, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01680172
First received: September 4, 2012
Last updated: January 29, 2016
Last verified: January 2016
Results First Received: January 29, 2016  
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
Conditions: Cancer
Depression
Anxiety
Interventions: Drug: Ketamine
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were recruited at Mayo Clinic in Scottsdale, Arizona from 2012 to 2014.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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


Participant Flow:   Overall Study
    Ketamine     Placebo  
STARTED     3     2  
COMPLETED     3     2  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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

Total Total of all reporting groups

Baseline Measures
    Ketamine     Placebo     Total  
Number of Participants  
[units: participants]
  3     2     5  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     3     0     3  
>=65 years     0     2     2  
Gender  
[units: participants]
     
Female     2     1     3  
Male     1     1     2  
Region of Enrollment  
[units: participants]
     
United States     3     2     5  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Hospital Anxiety and Depression Scale - Anxiety Score (HADS-A)   [ Time Frame: Baseline, 120 minutes ]

2.  Primary:   Hospital Anxiety Depression Scale- Depression Score (HADS-D)   [ Time Frame: Baseline, 120 minutes ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The study was terminated due to slow accrual rate. Data analysis limited to 5 participants.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Robert Bright, MD
Organization: Mayo Clinic
phone: 480-301-4853
e-mail: bright.robert@mayo.edu



Responsible Party: Robert P. Bright, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01680172     History of Changes
Other Study ID Numbers: 12-001156
Study First Received: September 4, 2012
Results First Received: January 29, 2016
Last Updated: January 29, 2016
Health Authority: United States: Institutional Review Board