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Ketamine Infusion for Treatment-resistant Major Depressive Disorder

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ClinicalTrials.gov Identifier: NCT01582945
Recruitment Status : Completed
First Posted : April 23, 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 Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Major Depressive Disorder
Intervention Drug: Ketamine
Enrollment 14
Recruitment Details Patients were referred to the study by their primary psychiatrists and no compensation was provided for participation.
Pre-assignment Details Subjects underwent a psychiatric screening evaluation, physical exam, EKG, laboratory testing, and a urine screening for substances of abuse to determine study eligibility.
Arm/Group Title Treatment-resistant Depression Patients
Hide Arm/Group Description Outpatient sample of patients (18-65 years old) with treatment-resistant major depressive disorder (TRD).
Period Title: Overall Study
Started 14
Completed 12
Not Completed 2
Reason Not Completed
Intolerable side-effects             1
Scheduling conflicts             1
Arm/Group Title Treatment-resistant Depression Patients
Hide Arm/Group Description Outpatient sample of patients (18-65 years old) with treatment-resistant major depressive disorder (TRD).
Overall Number of Baseline Participants 14
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants
<=18 years
0
   0.0%
Between 18 and 65 years
14
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 14 participants
50.0  (7.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants
Female
11
  78.6%
Male
3
  21.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 14 participants
14
Hamilton Rating Scale for Depression   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 14 participants
28.6  (4.8)
[1]
Measure Description: Scores may range from 0-81 with higher scores indicate greater depression severity. In order to be included in the study, participants must have had a Hamilton Depression Rating Scale–28 items (HAM-D28) score ⩾20 at screening.
1.Primary Outcome
Title Response to Ketamine as Measured by Hamilton Depression Rating Scale -28 Items (HAMD28)
Hide Description Patients will be assessed with HAMD-28 weekly for the first 8 weeks, then every two weeks for another 8 weeks. Participants were considered as responders if there was a ⩾50% improvement on the HAM-D28.
Time Frame Weekly for total duration of 4 months
Hide Outcome Measure Data
Hide Analysis Population Description
The subjects received a total of 6 infusions, twice a week for three weeks.
Arm/Group Title Ketamine IV
Hide Arm/Group Description:

Patients will receive open label augmentation with IV Ketamine at 0.5mg/kg over the course of 45 minutes, twice a week for 3 weeks. Participants received this dosage for the first three of six IV ketamine infusions. If participants do not experience an improvement of greater or equal to 30% in HAM-D scores after the first three infusions, the dose will be increased to 0.75mg/kg for the subsequent three infusions.

Ketamine: Ketamine IV 0.5mg/kg infusion twice a week for 3 weeks as augmentation of ongoing antidepressant regimen

Overall Number of Participants Analyzed 12
Measure Type: Number
Unit of Measure: participants who met response criteria
5
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Ketamine IV
Hide Arm/Group Description

Patients will receive open label augmentation with IV Ketamine at 0.5mg/kg, twice a week for 3 weeks

Ketamine: Ketamine IV 0.5mg/kg infusion twice a week for 3 weeks as augmentation of ongoing antidepressant regimen

All-Cause Mortality
Ketamine IV
Affected / at Risk (%)
Total   0/14 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Ketamine IV
Affected / at Risk (%)
Total   0/14 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Ketamine IV
Affected / at Risk (%)
Total   0/14 (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: 6177266421
Responsible Party: Cristina Cusin, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01582945     History of Changes
Other Study ID Numbers: 2010-P-002800
First Submitted: April 17, 2012
First Posted: April 23, 2012
Results First Submitted: March 2, 2017
Results First Posted: April 20, 2017
Last Update Posted: April 20, 2017