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CompletedPhase 2Results posted

Ketamine Infusion for Obsessive-Compulsive Disorder

NCT01349231 · Yale University

Closed to entry
Status
Not accepting participants
Phase 2
Phase
10
Target enrolment
1
Study sites
1 US states

What it is testing

Summary

Roughly one-third of patients with obsessive-compulsive disorder (OCD) do not experience significant clinical benefit from first-line interventions such as pharmacotherapy with selective serotonin reuptake inhibitors (SSRI) or cognitive behavioral therapy (CBT). Furthermore, OCD patients typically experience the full treatment benefits of first-line interventions only after a time-lag of two to three months. Inadequate symptom relief and delay of symptom relief from first-line treatments are sources of substantial morbidity and decreased quality of life in OCD patients. Converging lines of evidence from neuroimaging, genetic and pharmacological studies support the importance of glutamate abnormalities in the pathogenesis of OCD. The investigators are conducting an open, uncontrolled study of ketamine in treatment-refractory OCD. Ketamine is a potent antagonist of the N-methyl-D-aspartate (NMDA) receptor and has been demonstrated to have rapid anti-depressant effects in patients with Major Depressive Disorder. The investigators have additionally provided evidence for rapid improvement of comorbid OCD and trichotillomania after ketamine infusion in a depressed woman. Failure of symptom relief and delay of symptom relief from first-line treatments are a source of substantial morbidity and decreased quality of life in OCD patients. Ketamine represents the possibility to provide rapid symptom relief to OCD patients and may provide the mechanism for future drug development to treat OCD more rapidly and effectively.

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

  • OCD Severity

    Measured over Baseline and 1 day after ketamine infusion

  • OCD Severity

    Measured over Baseline and 2 days following infusion

  • OCD Severity

    Measured over Baseline and 3 days following infusion

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

18 Years to 65 Years
Ages
All
Sex
Not accepted
Healthy volunteers
Inclusion Criteria: 1. Adult between the ages of 18 and 65 years. 2. Meet DSM IV criteria for obsessive-compulsive disorder by structured clinical interview (SCID) and have a Y-BOCS score \>24. 3. Have treatment-refractory OCD. Have Y-BOCS\>24 despite two SSRI trials of adequate dose and duration and been offered prior CBT treatment. 4. Stable psychiatric medications. Subjects must have had stable doses of all psychiatric medications for the month prior to treatment and have been on stable doses of SSRI and clomipramine for at least 2 months prior to study enrollment. 5. Medically and neurologically healthy. 6. Able to provide written informed consent according to the Yale HIC guidelines. Exclusion Criteria: 1. Lifetime history of substance dependence (other than nicotine and caffeine) 2. Suicide attempt or suicidal ideation requiring psychiatric hospitalization in the previous 6 months 3. Being Pregnant 4. Known hypersensitivity to ketamine

Where

1 study site

FacilityCityRegionCountry
Connecticut Mental Health Center/ YNHHNew HavenConnecticutUnited 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.

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NCT01349231 on ClinicalTrials.gov →

Last updated in the registry 2014-06-09. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits