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Ketamine Versus Placebo for Treatment Resistant Major Depressive Disorder

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Cristina Cusin, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01667926
First received: August 15, 2012
Last updated: April 18, 2017
Last verified: April 2017
Results First Received: March 2, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Major Depressive Disorder
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
Outpatients were recruited primarily through referrals.

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

Subject will receive 6 infusions of ketamine over three weeks.

Ketamine: ketamine infusions twice a week for three weeks, total of 6 infusions as augmentation of ongoing antidepressant regimen.

Placebo

Subjects will receive 6 infusions of normal saline over 3 weeks.

Placebo

Screen Fail/No Baseline

Participants who signed informed consent and were screened but did not meet study inclusion/exclusion criteria.

Participants in the screen fail group were not randomized to either Ketamine nor placebo and did not receive any infusions.


Participant Flow:   Overall Study
    Ketamine   Placebo   Screen Fail/No Baseline
STARTED   13   13   11 
COMPLETED   8   9   0 [1] 
NOT COMPLETED   5   4   11 
Withdrawal by Subject                1                2                2 
Physician Decision                0                0                1 
Time committment                0                0                2 
Inclusion/Exclusion Criteria                0                0                5 
Lost to Follow-up                1                2                1 
Side effects                3                0                0 
[1] Participants in the screen fail group were not randomized in the study.



  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

Subject will receive 6 infusions of ketamine over three weeks.

Ketamine: ketamine infusions twice a week for three weeks, total of 6 infusions as augmentation of ongoing antidepressant regimen.

Placebo

Subjects will receive 6 infusions of normal saline over 3 weeks.

Placebo

Total Total of all reporting groups

Baseline Measures
   Ketamine   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 13   13   26 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      13 100.0%      13 100.0%      26 100.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 45.5  (13.6)   45.3  (11.7)   45.4  (12.4) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      7  53.8%      3  23.1%      10  38.5% 
Male      6  46.2%      10  76.9%      16  61.5% 
Region of Enrollment 
[Units: Participants]
Count of Participants
     
United States   13   13   26 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Hamilton Depression Rating Scale - Suicidal Ideation (HDRS-SI)   [ Time Frame: up to 4 months ]

2.  Secondary:   HDRS-28 Total   [ Time Frame: up to 5 months ]


  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
No text entered.


  More Information
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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: 6177263855
e-mail: ccusin@mgh.harvard.edu



Responsible Party: Cristina Cusin, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01667926     History of Changes
Other Study ID Numbers: 2012-P-001042
Study First Received: August 15, 2012
Results First Received: March 2, 2017
Last Updated: April 18, 2017