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Physiological and Cognitive Biomarkers for Ketamine's Antidepressant Effects

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ClinicalTrials.gov Identifier: NCT02669043
Recruitment Status : Terminated (Funding ended.)
First Posted : January 29, 2016
Results First Posted : February 28, 2017
Last Update Posted : April 23, 2018
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Cristina Cusin, MD, Massachusetts General Hospital

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Other
Condition Depression
Intervention Drug: Ketamine
Enrollment 8
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Ketamine
Hide Arm/Group Description

All participants receive open-label ketamine

Ketamine: Intravenous ketamine 0.5mg/kg over 40 minutes

Period Title: Overall Study
Started 8
Completed 4
Not Completed 4
Reason Not Completed
Didn't meet I/E criteria             4
Arm/Group Title Ketamine
Hide Arm/Group Description

All participants receive open-label ketamine

Ketamine: Intravenous ketamine 0.5mg/kg over 40 minutes

Overall Number of Baseline Participants 8
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants
<=18 years
0
   0.0%
Between 18 and 65 years
8
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 8 participants
48.3
(34 to 64)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants
Female
6
  75.0%
Male
2
  25.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants
American Indian or Alaska Native
0
   0.0%
Asian
1
  12.5%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
7
  87.5%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 8 participants
8
HAMD Total Score   [1] 
Mean (Full Range)
Unit of measure:  Units on a scale
Number Analyzed 8 participants
28.5
(25 to 31)
[1]
Measure Description: Depression rating scale; possible scores range from 0 to 81 with higher scores indicating higher depression symptoms.
1.Primary Outcome
Title Hamilton Depression Rating Scale (HDRS, HAM-D)
Hide Description Continuous score of depression symptoms. The higher the score, the more severe the depression. HAMD scores range from 0 to 81.
Time Frame 48 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Patients who completed the study. Outcome measure was at 48 hours.
Arm/Group Title Ketamine
Hide Arm/Group Description:

All participants receive open-label ketamine

Ketamine: Intravenous ketamine 0.5mg/kg over 40 minutes

Overall Number of Participants Analyzed 4
Mean (Full Range)
Unit of Measure: units on a scale
11.5
(5 to 27)
Time Frame 4 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Ketamine
Hide Arm/Group Description

All participants receive open-label ketamine

Ketamine: Intravenous ketamine 0.5mg/kg over 40 minutes

All-Cause Mortality
Ketamine
Affected / at Risk (%)
Total   0/8 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Ketamine
Affected / at Risk (%)
Total   0/8 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Ketamine
Affected / at Risk (%)
Total   0/8 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr.Cristina Cusin
Organization: Massachusetts General Hospital
Phone: 617-726-6421
Responsible Party: Cristina Cusin, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT02669043     History of Changes
Other Study ID Numbers: 2015P002397
K23MH107776 ( U.S. NIH Grant/Contract )
First Submitted: January 27, 2016
First Posted: January 29, 2016
Results First Submitted: February 24, 2017
Results First Posted: February 28, 2017
Last Update Posted: April 23, 2018