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TerminatedPhase 1 / Phase 2Results posted

Intravenous Ketamine in the Treatment of Obsessive-Compulsive Disorder

NCT01371110 · IVKetamine · Wayne Goodman MD

Closed to entry
Status
Not accepting participants
Phase 1 / Phase 2
Phase
3
Target enrolment
1
Study sites
1 US states

What it is testing

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.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Change in Yale-Brown Obsessive Compulsive Scale (Y-BOCCS) Rating OCD Symptom Severity From Baseline to 24-hours After Ketamine Administration

    Measured over Baseline and 24 Hours

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

21 Years to 65 Years
Ages
All
Sex
Not accepted
Healthy volunteers
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

Where

1 study site

FacilityCityRegionCountry
Clinical Research Centers at Icahn School of Medicine at Mount SinaiNew YorkNew YorkUnited States

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT01371110 on ClinicalTrials.gov →

Last updated in the registry 2018-01-18. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits

Substance

Recruiting in