Clinical trial NCT01371110: Intravenous Ketamine in the Treatment of Obsessive-Compulsive Disorder
Official title: Intravenous Ketamine in the Treatment of Obsessive-Compulsive Disorder
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Obsessive Compulsive Disorder
Keywords: OCD
Obsessive-Compulsive Disorder
ketamine
treatment
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
Collaborators: name: Icahn School of Medicine at Mount Sinai
First posted: 2011-06-10
Enrollment: 3
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Obsessive-Compulsive Disorder (OCD) is a chronic and disabling anxiety disorder and a leading cause of worldwide disability that presents a significant public health problem. Treatment options are limited and many OCD patients fail to respond completely or quickly to standard treatments, including pharmacotherapy and psychotherapy. At this time, patients who fail to respond to treatment with serotonergic drugs, augmenting antipsychotic agents, and behavioral therapy, have few additional treatment options aside from deep brain stimulation. Therefore, despite advances in current pharmacological and behavioral treatments, and the utility of serotonergic drugs, it is likely that other neurotransmitter systems are involved and that targeting these systems may increase treatment efficacy. Despite little evidence for serotonergic dysfunction in OCD, there is significant evidence that glutamatergic dysregulation may contribute to the development and progression of the disorder. Also, preliminary studies suggest that glutamatergic modulators (i.e. riluzole and d-cycloserine), particularly agents acting at the NMDA receptor (i.e. memantine), may be useful in OCD. The NMDA antagonist, ketamine, has demonstrated rapid effects when delivered as a single intravenous (IV) dose in depressed patients. Therefore, the objective of the current study is to investigate the safety and efficacy of a single dose of IV ketamine in treatment-resistant OCD.

Detailed description: This study will test the safety and efficacy of a single intravenous (IV) dose of the N-methyl-D-aspartate (NMDA) glutamate receptor antagonist, ketamine, in treatment-resistant OCD.

Eligibility criteria: Inclusion Criteria:

* Male or female patients, 21-65 years
* Women of childbearing potential must agree to use a medically accepted means of contraception for the duration of the study
* Primary diagnosis of Obsessive-Compulsive Disorder as assessed by the SCID-P, with symptoms for at least 1 year (Patients who meet criteria for OCD will be required to be medication free or have all psychotropics aside from SSRIs and as needed benzodiazepines tapered. Prior to study entry, proscribed psychotropics are tapered, and subjects must be on the same SSRI for at least 8 weeks with no change in dose for at least 4 weeks and throughout the study. However, subjects will be allowed to use benzodiazepines as needed throughout the study.)
* History of a failure to respond to at least two (2) adequate pharmacotherapy trials and CBT for OCD
* Subjects must have scored ≥ 21 on the Y-BOCS at Screening, and to not be in remission on Treatment Day #1, and Treatment Day #2
* Each subject must have a level of understanding sufficient to agree to all tests and examinations required by the protocol and must sign an informed consent document
* Subjects must be able to identify a family member, physician, or friend who will participate in the Treatment Contract and serve as an emergency contact.

Exclusion Criteria:

* Women who plan to become pregnant within the next six months, are pregnant or are breast-feeding
* Non-English speakers
* Any unstable medical illness including hepatic, renal, gastroenterologic, respiratory, cardiovascular, endocrinologic, neurologic, immunologic, or hematologic disease
* Clinically significant abnormal findings of laboratory parameters, physical examination, or ECG
* Lifetime history of schizophrenia, schizoaffective disorder, bipolar disorder, mental retardation, or pervasive developmental disorders
* Current evidence of psychotic or manic symptoms
* Drug or alcohol abuse or dependence within the preceding 6 months
* Lifetime abuse or dependence on ketamine or phencyclidine
* Patients judged by study investigator to be at high risk for suicide
* Current use of psychotropics other than SSRIs

Primary outcomes:
measure: Change in Yale-Brown Obsessive Compulsive Scale (Y-BOCCS) Rating OCD Symptom Severity From Baseline to 24-hours After Ketamine Administration
timeFrame: Baseline and 24 Hours
Secondary outcomes:
measure: Percentage of Patients Who Meet Response and Remission
timeFrame: up to 14 days
Other outcomes:
Locations:
city: New York
country: United States
facility: Clinical Research Centers at Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Baylor College of Medicine (previously Icahn School of Medicine at Mount Sinai)
name: Wayne K Goodman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: (previously Icahn School of Medicine at Mount Sinai)
name: Kyle Lapidus, MD
role: PRINCIPAL_INVESTIGATOR
References: