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Phase 2 N=10 Treatment

Ketamine Infusion for Obsessive-Compulsive Disorder

Obsessive-compulsive Disorder

Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Jun 2014
Primary outcome: Primary: OCD Severity — -2.7 units on a scale

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
ketamine (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Yale University
Primary completion
Dec 2011

Outcome Measures

OutcomeResultp-value
PRIMARY
OCD Severity
-2.9
PRIMARY
OCD Severity
-2.9
PRIMARY
OCD Severity
-2.9
SECONDARY
Depression Symptoms
-6.57; -7.29; -5.14

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.

Eligibility Criteria

Inclusion Criteria

  • Adult between the ages of 18 and 65 years.
  • Meet DSM IV criteria for obsessive-compulsive disorder by structured clinical interview (SCID) and have a Y-BOCS score >24.
  • Have treatment-refractory OCD. Have Y-BOCS>24 despite two SSRI trials of adequate dose and duration and been offered prior CBT treatment.
  • 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.
  • Medically and neurologically healthy.
  • Able to provide written informed consent according to the Yale HIC guidelines.

Exclusion Criteria

  • Lifetime history of substance dependence (other than nicotine and caffeine)
  • Suicide attempt or suicidal ideation requiring psychiatric hospitalization in the previous 6 months
  • Being Pregnant
  • Known hypersensitivity to ketamine
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01349231). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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