Intravenous Ketamine in the Treatment of Obsessive-Compulsive Disorder
| Status: | Terminated |
|---|---|
| Conditions: | Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 21 - 65 |
| Updated: | 1/20/2018 |
| Start Date: | June 2012 |
| End Date: | June 2015 |
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.
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.
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.
N-methyl-D-aspartate (NMDA) glutamate receptor antagonist, ketamine, in treatment-resistant
OCD.
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
We found this trial at
1
site
Click here to add this to my saved trials
