Status:
TERMINATED
A Trial of Intranasal Ketamine for the Treatment of Obsessive-Compulsive Disorder
Lead Sponsor:
Mclean Hospital
Conditions:
Obsessive-Compulsive Disorder
Eligibility:
All Genders
18-55 years
Phase:
PHASE2
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....
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2016
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT02234011
Start Date
September 1 2014
End Date
January 1 2016
Last Update
May 12 2017
Active Locations (1)
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1
McLean Hospital
Belmont, Massachusetts, United States, 02478