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Intravenous Ketamine in the Treatment of Obsessive-Compulsive Disorder (IVKetamine)

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ClinicalTrials.gov Identifier: NCT01371110
Recruitment Status : Terminated (no funding)
First Posted : June 10, 2011
Results First Posted : October 2, 2017
Last Update Posted : January 18, 2018
Sponsor:
Collaborator:
Icahn School of Medicine at Mount Sinai
Information provided by (Responsible Party):
Wayne Goodman MD, Baylor College of Medicine

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Obsessive Compulsive Disorder
Interventions Drug: Ketamine
Drug: Midazolam
Enrollment 3
Recruitment Details Subjects were recruited from the Mood and Anxiety Disorders Program (MAPs). In addition, referrals from clinicians in the Mount Sinai Medical Center, community clinics, and affiliated hospitals were also sought.
Pre-assignment Details Eligible participants met treatment-resistant criteria if they failed to respond to ≥ 2 adequate pharmacotherapy trials with SRIs FDA approved medications for OCD with or without adjunctive antipsychotics, as well as cognitive behavioral therapy.
Arm/Group Title Ketamine (Randomized Week 1, Cross Over Midazolam Week 3)) Midazolam (Randomized Wk 1, Cross Over Ketamine Wk 3)
Hide Arm/Group Description

Study participants will receive a one-time intravenous infusion of 0.5 mg/kg racemic ketamine hydrochloride

Ketamine: Ketamine hydrochloride is a nonbarbiturate anesthetic. It is formulated as a slight acid (pH 3.5 to 5.5) sterile solution for intravenous or intramuscular injection in concentrations containing the equivalent of either 50 or 100mg ketamine base per milliliter.

Study participants will receive a one-time intravenous infusion of 0.045 mg/kg midazolam

Midazolam: Midazolam is a short-acting benzodiazepine central nervous (CNS) depressant.

Period Title: Overall Study
Started 1 2
Completed 1 2
Not Completed 0 0
Arm/Group Title Ketamine (Randomized Week 1, Cross Over Midazolam Week 3)) Midazolam (Randomized Wk 1, Cross Over Ketamine Wk 3) Total
Hide Arm/Group Description

Study participants will receive a one-time intravenous infusion of 0.5 mg/kg racemic ketamine hydrochloride

Ketamine: Ketamine hydrochloride is a nonbarbiturate anesthetic. It is formulated as a slight acid (pH 3.5 to 5.5) sterile solution for intravenous or intramuscular injection in concentrations containing the equivalent of either 50 or 100mg ketamine base per milliliter.

Study participants will receive a one-time intravenous infusion of 0.045 mg/kg midazolam

Midazolam: Midazolam is a short-acting benzodiazepine central nervous (CNS) depressant.

Total of all reporting groups
Overall Number of Baseline Participants 1 2 3
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants 2 participants 3 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
1
 100.0%
2
 100.0%
3
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 1 participants 2 participants 3 participants
49
(49 to 49)
48.5
(34 to 63)
48.6
(34 to 63)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants 2 participants 3 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
1
 100.0%
2
 100.0%
3
 100.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants 2 participants 3 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
0
   0.0%
0
   0.0%
0
   0.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
1
 100.0%
2
 100.0%
3
 100.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 1 participants 2 participants 3 participants
1
 100.0%
2
 100.0%
3
 100.0%
1.Primary Outcome
Title Change in Yale-Brown Obsessive Compulsive Scale (Y-BOCCS) Rating OCD Symptom Severity From Baseline to 24-hours After Ketamine Administration
Hide Description

The primary efficacy outcome is change in the Y-BOCCS rating score on a scale from baseline to 24 hrs post-administration of ketamine.

The 10 Y-BOCCS items are each scored on a four-point scale from 0 = "no symptoms" to 4 = "extreme symptoms." The sum of the first five items is a severity index for obsessions. The sum of the last five an index for compulsions. A translation of total score into an approximate index of overall severity is: 0-7 - subclinical; 8-15 - mild; 16-23 - moderate; 24-31 - severe; 32-40 - extreme.

Time Frame Baseline and 24 Hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ketamine (Randomized Week 1, Cross Over Midazolam Week 3)) Midazolam (Randomized Wk 1, Cross Over Ketamine Wk 3)
Hide Arm/Group Description:

Study participants will receive a one-time intravenous infusion of 0.5 mg/kg racemic ketamine hydrochloride

Ketamine: Ketamine hydrochloride is a nonbarbiturate anesthetic. It is formulated as a slight acid (pH 3.5 to 5.5) sterile solution for intravenous or intramuscular injection in concentrations containing the equivalent of either 50 or 100mg ketamine base per milliliter.

Study participants will receive a one-time intravenous infusion of 0.045 mg/kg midazolam

Midazolam: Midazolam is a short-acting benzodiazepine central nervous (CNS) depressant.

Overall Number of Participants Analyzed 1 2
Mean (Full Range)
Unit of Measure: Units on a scale
-2.98
(-2.98 to -2.98)
-2.185
(-14.98 to 10.61)
2.Secondary Outcome
Title Percentage of Patients Who Meet Response and Remission
Hide Description Percentage of patients who meet response (defined as 25% reduction in Y-BOCCS score) and remission (defined as Y-BOCS score ≤10) criteria at 24 hrs post-infusion and durability of efficacy up to two weeks after administration. Assessments will be performed 24, 48 and 72 hrs post-infusion and after 7, 10, and 14 days.
Time Frame up to 14 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ketamine (Randomized Week 1, Cross Over Midazolam Week 3)) Midazolam (Randomized Wk 1, Cross Over Ketamine Wk 3)
Hide Arm/Group Description:

Study participants will receive a one-time intravenous infusion of 0.5 mg/kg racemic ketamine hydrochloride

Ketamine: Ketamine hydrochloride is a nonbarbiturate anesthetic. It is formulated as a slight acid (pH 3.5 to 5.5) sterile solution for intravenous or intramuscular injection in concentrations containing the equivalent of either 50 or 100mg ketamine base per milliliter.

Study participants will receive a one-time intravenous infusion of 0.045 mg/kg midazolam

Midazolam: Midazolam is a short-acting benzodiazepine central nervous (CNS) depressant.

Overall Number of Participants Analyzed 1 2
Measure Type: Number
Unit of Measure: percentage of participants
0 50
Time Frame 4 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Ketamine Midazolam
Hide Arm/Group Description

Study participants will receive a one-time intravenous infusion of 0.5 mg/kg racemic ketamine hydrochloride

Ketamine: Ketamine hydrochloride is a nonbarbiturate anesthetic. It is formulated as a slight acid (pH 3.5 to 5.5) sterile solution for intravenous or intramuscular injection in concentrations containing the equivalent of either 50 or 100mg ketamine base per milliliter.

Study participants will receive a one-time intravenous infusion of 0.045 mg/kg midazolam

Midazolam: Midazolam is a short-acting benzodiazepine central nervous (CNS) depressant.

All-Cause Mortality
Ketamine Midazolam
Affected / at Risk (%) Affected / at Risk (%)
Total   0/1 (0.00%)      0/2 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Ketamine Midazolam
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/1 (0.00%)      0/2 (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 Midazolam
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/1 (100.00%)      1/2 (50.00%)    
Gastrointestinal disorders     
Diarrhea   0/1 (0.00%)  0 1/2 (50.00%)  1
Nervous system disorders     
Dizziness   0/1 (0.00%)  0 1/2 (50.00%)  1
Headache   1/1 (100.00%)  1 0/2 (0.00%)  0
Psychiatric disorders     
Suicidality   0/1 (0.00%)  0 1/2 (50.00%)  1
Fatigue   1/1 (100.00%)  1 0/2 (0.00%)  0
Indicates events were collected by systematic assessment
Early termination due to limited funding lead to small numbers of subjects analyzed (n=3) compared to what was planned (n=12).
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
Layout table for Results Point of Contact information
Name/Title: Wayne Goodman
Organization: Baylor College of Medicine (previously Icahn School of Medicine at Mount Sinai)
Phone: 713-798-4945
EMail: wayne.goodman@bcm.edu
Layout table for additonal information
Responsible Party: Wayne Goodman MD, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT01371110     History of Changes
Other Study ID Numbers: GCO 11-1113
HSM#11-01536 ( Other Identifier: THE MOUNT SINAI HEALTH SYSTEM )
First Submitted: June 7, 2011
First Posted: June 10, 2011
Results First Submitted: April 18, 2017
Results First Posted: October 2, 2017
Last Update Posted: January 18, 2018