Back to resultsA Trial of Intranasal Ketamine for the Treatment of Obsessive-Compulsive Disorder
Primary Purpose
Obsessive-Compulsive Disorder
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Ketamine
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Obsessive-Compulsive Disorder
Eligibility Criteria
Inclusion Criteria:
- Male or female age ≥ 18 and ≤ 55
- Meets DSM-IV50 criteria for OCD as the primary presenting diagnosis as determined by the investigator (participants with secondary comorbid dysthymia, major depression, anxiety disorders, eating disorders, and other obsessive-compulsive spectrum disorders will still be eligible for enrollment).
- Score of ≥ 18 on the Y-BOCS at screening
Exclusion Criteria:
- Unwillingness or inability to provide written informed consent.
- Active suicidal ideation at screening
- Lifetime history of psychotic disorder or autism spectrum disorder
- DSM-IV diagnosis of alcohol or substance dependence, with the exception of nicotine dependence, within three months prior to screening
- Any history of intolerance or hypersensitivity to ketamine
- Any history of nasal/sinus anomalies or dysfunction (e.g., nasal obstruction or history of nasal surgery)
- Clinically significant medical disease including, but not limited to, cardiac (including uncontrolled hypertension or uncontrolled hypotension, arrhythmias, congestive heart failure, angina), pulmonary, hepatic, renal, or endocrine disorders, which would increase the risk to the participant or interfere with interpretation of results as judged by the principal investigator.
- Clinically significant neurologic disease including, but not limited to, seizure disorder, neurodegenerative diseases, transient ischemic attacks, neural vascular disease, stroke, cerebral aneurysms, and history of traumatic brain injury.
- Female participants with a positive serum or urine pregnancy test at screening
- Pregnancy. Females of childbearing potential must be using an effective contraceptive method (e.g., abstinence, prescription oral contraceptives, contraceptive injections, double-barrier method, male partner sterilization). Women that are not of childbearing potential are defined as: postmenopausal (>45 years of age with amenorrhea for at least 12 months, or any age with menorrhea for at least 6 months and a serum follicle stimulating hormone (FSH) level >40 IU/ml); permanently sterilized (e.g., tubal occlusion, hysterectomy, bilateral salpingectomy); or otherwise be incapable of pregnancy.
- Female participants who are lactating.
- Any screening laboratory abnormality deemed clinically significant by the investigator
- Currently taking opiate pain medications, dextromethorphan, St. John's Wort, theophylline, or tramadol.
- Any participation in an investigational drug trial within 30 days of enrollment in study.
- Contraindication to having an MRI.
Sites / Locations
- McLean Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Ketamine/Placebo
Placebo/Ketamine
Arm Description
Participants in this group will receive 5 sprays (10 mg each) of intranasal ketamine for the first treatment visit, then receive 5 sprays of placebo (saline solution) at the second treatment visit two weeks later.
Participants in this group will receive 5 sprays of placebo (saline solution) for the first treatment visit, then receive 5 sprays (10 mg each) of intranasal ketamine at the second treatment visit two weeks later.
Outcomes
Primary Outcome Measures
Observing if Ketamine May Cause a Decrease in OCD Symptoms
Examining if ketamine is associated with a decrease in OCD symptoms as measured by the Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) at completion of one treatment when compared to placebo (saline solution).
The Y-BOCS measures OCD symptoms on a scale of 0-40, with higher numbers indicating greater severity of OCD symptoms. For this study, subjects had to have a Y-BOCS of greater than or equal to 18 in order to participate.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02234011
Brief Title
A Trial of Intranasal Ketamine for the Treatment of Obsessive-Compulsive Disorder
Official Title
A Placebo-Controlled Crossover Trial of Intranasal Ketamine for the Treatment of Obsessive-Compulsive Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Terminated
Why Stopped
Terminated due to difficulty in recruiting participants.
Study Start Date
September 2014 (Actual)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
January 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mclean Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study is being done to learn whether administration of intranasal (inhaled through the nose) ketamine reduces symptoms of obsessive-compulsive disorder (OCD). Ketamine has been approved by the U.S. Food and Drug Administration (FDA) as an anesthetic agent (a medicine to reduce pain during surgery and other procedures) but ketamine has not been approved by the FDA as a treatment for OCD.
The investigators believe that ketamine may be effective in reducing symptoms of OCD due to its ability to decrease the activity of a specific brain chemical called glutamate. Previous studies have shown that people with OCD can have abnormal levels of glutamate in their brains. This is the first time that intranasal ketamine is being studied in people with OCD. However, studies have been done in the past using intravenous (IV; through a needle into a vein in your arm) ketamine in people with OCD, and intranasal ketamine has been studied in people with other psychiatric conditions.
This research study will compare ketamine to placebo. The placebo looks exactly like ketamine, but contains no ketamine. At some time during the study, the investigators will give you ketamine. At another time, the investigators will give you placebo. Placebos are used in research studies to see if the results are due to the study drug or due to other reasons.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obsessive-Compulsive Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
1 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ketamine/Placebo
Arm Type
Experimental
Arm Description
Participants in this group will receive 5 sprays (10 mg each) of intranasal ketamine for the first treatment visit, then receive 5 sprays of placebo (saline solution) at the second treatment visit two weeks later.
Arm Title
Placebo/Ketamine
Arm Type
Experimental
Arm Description
Participants in this group will receive 5 sprays of placebo (saline solution) for the first treatment visit, then receive 5 sprays (10 mg each) of intranasal ketamine at the second treatment visit two weeks later.
Intervention Type
Drug
Intervention Name(s)
Ketamine
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Observing if Ketamine May Cause a Decrease in OCD Symptoms
Description
Examining if ketamine is associated with a decrease in OCD symptoms as measured by the Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) at completion of one treatment when compared to placebo (saline solution).
The Y-BOCS measures OCD symptoms on a scale of 0-40, with higher numbers indicating greater severity of OCD symptoms. For this study, subjects had to have a Y-BOCS of greater than or equal to 18 in order to participate.
Time Frame
Baseline to Week 5
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female age ≥ 18 and ≤ 55
Meets DSM-IV50 criteria for OCD as the primary presenting diagnosis as determined by the investigator (participants with secondary comorbid dysthymia, major depression, anxiety disorders, eating disorders, and other obsessive-compulsive spectrum disorders will still be eligible for enrollment).
Score of ≥ 18 on the Y-BOCS at screening
Exclusion Criteria:
Unwillingness or inability to provide written informed consent.
Active suicidal ideation at screening
Lifetime history of psychotic disorder or autism spectrum disorder
DSM-IV diagnosis of alcohol or substance dependence, with the exception of nicotine dependence, within three months prior to screening
Any history of intolerance or hypersensitivity to ketamine
Any history of nasal/sinus anomalies or dysfunction (e.g., nasal obstruction or history of nasal surgery)
Clinically significant medical disease including, but not limited to, cardiac (including uncontrolled hypertension or uncontrolled hypotension, arrhythmias, congestive heart failure, angina), pulmonary, hepatic, renal, or endocrine disorders, which would increase the risk to the participant or interfere with interpretation of results as judged by the principal investigator.
Clinically significant neurologic disease including, but not limited to, seizure disorder, neurodegenerative diseases, transient ischemic attacks, neural vascular disease, stroke, cerebral aneurysms, and history of traumatic brain injury.
Female participants with a positive serum or urine pregnancy test at screening
Pregnancy. Females of childbearing potential must be using an effective contraceptive method (e.g., abstinence, prescription oral contraceptives, contraceptive injections, double-barrier method, male partner sterilization). Women that are not of childbearing potential are defined as: postmenopausal (>45 years of age with amenorrhea for at least 12 months, or any age with menorrhea for at least 6 months and a serum follicle stimulating hormone (FSH) level >40 IU/ml); permanently sterilized (e.g., tubal occlusion, hysterectomy, bilateral salpingectomy); or otherwise be incapable of pregnancy.
Female participants who are lactating.
Any screening laboratory abnormality deemed clinically significant by the investigator
Currently taking opiate pain medications, dextromethorphan, St. John's Wort, theophylline, or tramadol.
Any participation in an investigational drug trial within 30 days of enrollment in study.
Contraindication to having an MRI.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian P Brennan, M.D.
Organizational Affiliation
Mclean Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
McLean Hospital
City
Belmont
State/Province
Massachusetts
ZIP/Postal Code
02478
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Trial of Intranasal Ketamine for the Treatment of Obsessive-Compulsive Disorder
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