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Ketamine Versus Placebo for Treatment Resistant Major Depressive Disorder

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ClinicalTrials.gov Identifier: NCT01667926
Recruitment Status : Completed
First Posted : August 17, 2012
Results First Posted : April 20, 2017
Last Update Posted : April 20, 2017
Sponsor:
Information provided by (Responsible Party):
Cristina Cusin, MD, Massachusetts General Hospital

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
Enrollment 37

Recruitment Details Outpatients were recruited primarily through referrals.
Pre-assignment Details  
Arm/Group Title Ketamine Placebo Screen Fail/No Baseline
Hide Arm/Group Description

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.

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

Placebo

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.

Period Title: Overall Study
Started 13 13 11
Completed 8 9 0 [1]
Not Completed 5 4 11
Reason Not Completed
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.
Arm/Group Title Ketamine Placebo Total
Hide Arm/Group Description

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.

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

Placebo

Total of all reporting groups
Overall Number of Baseline Participants 13 13 26
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 13 participants 26 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, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 13 participants 13 participants 26 participants
45.5  (13.6) 45.3  (11.7) 45.4  (12.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 13 participants 26 participants
Female
7
  53.8%
3
  23.1%
10
  38.5%
Male
6
  46.2%
10
  76.9%
16
  61.5%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 13 participants 13 participants 26 participants
13
 100.0%
13
 100.0%
26
 100.0%
1.Primary Outcome
Title Hamilton Depression Rating Scale - Suicidal Ideation (HDRS-SI)
Hide Description The HDRS-SI score consists of a single item on the Hamilton Depression Rating Scale (HDRS). Scores range from 0 to 4, with 0 representing no suicidal ideation, and 4 representing a suicide attempt.
Time Frame up to 4 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ketamine Placebo
Hide Arm/Group Description:

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.

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

Placebo

Overall Number of Participants Analyzed 8 9
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.6  (1.4) 1.6  (1.4)
2.Secondary Outcome
Title HDRS-28 Total
Hide Description Hamilton Depression Rating Scale Total scores after completing 6 infusions. Scores may range from 0-81 with higher scores indicating greater depression severity. HDRS-28 score ≤ 7 was considered remission.
Time Frame up to 5 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ketamine Placebo
Hide Arm/Group Description:

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.

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

Placebo

Overall Number of Participants Analyzed 8 9
Mean (Standard Deviation)
Unit of Measure: units on a scale
20.2  (11.1) 20.0  (10.7)
Time Frame up to 3 months
Adverse Event Reporting Description Adverse events were tracked from Baseline to three months after final infusion in a naturalistic "follow-up" phase.
 
Arm/Group Title Ketamine Placebo
Hide Arm/Group Description

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.

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

Placebo

All-Cause Mortality
Ketamine Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Ketamine Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/13 (15.38%)      0/13 (0.00%)    
Infections and infestations     
Unrelated hospitalization * [1]  1/13 (7.69%)  1 0/13 (0.00%)  0
Psychiatric disorders     
Worsening Depression * [2]  2/13 (15.38%)  2 0/13 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
[1]
The subject was hospitalized due to syncope. This event very unlikely related to the study medication, due to the significant time delay between the final infusion and the episodes of syncope. The most probable explanation is a viral infection.
[2]
Participant was hospitalized due to worsening depression and suicidal ideation. Study team was notified by the participant via phone call or email.
Show Other (Not Including Serious) Adverse Events Hide 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   3/13 (23.08%)      1/13 (7.69%)    
General disorders     
Ketamine side effects * [1]  2/13 (15.38%)  3 0/13 (0.00%)  0
Diarrhea *  1/13 (7.69%)  1 0/13 (0.00%)  0
Blood Pressure elevated *  1/13 (7.69%)  1 0/13 (0.00%)  0
Psychiatric disorders     
Psychiatric Hospitalization *  0/13 (0.00%)  0 1/13 (7.69%)  1
*
Indicates events were collected by non-systematic assessment
[1]
Including dizziness, fever, fainting, and detachment from reality
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
Responsible Party: Cristina Cusin, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01667926     History of Changes
Other Study ID Numbers: 2012-P-001042
First Submitted: August 15, 2012
First Posted: August 17, 2012
Results First Submitted: March 2, 2017
Results First Posted: April 20, 2017
Last Update Posted: April 20, 2017