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CompletedNCT00211744Updated May 30, 2018

Topiramate Augmentation in the Treatment of Obsessive-Compulsive Disorder

A Phase 4 interventional study of topiramate in Obsessive-compulsive Disorder, sponsored by Montefiore Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2018-05-30.

Sponsored by Montefiore Medical Center · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

A 12-week program to examine the effectiveness of topiramate in adjunctive treatment for adults with obsessive-compulsive disorder and who are currently on serotonin reuptake inhibitor medications (ages 18-65).

Read the detailed description

The Compulsive, Impulsive and Anxiety Disorders Program at the Mount Sinai School of Medicine is conducting a study of Topiramate (Topamax) added to an SSRI for the management of treatment-resistant Obsessive-Compulsive Disorder. The purpose of the study is to evaluate the safety and efficacy of Topiramate versus placebo added to a selective serotonin reuptake inhibitor (SRI) in patients with treatment resistant OCD. The program is 12 weeks in duration and involves regular visits with a psychiatrist as well as complete psychiatric and medical evaluations. Treatment and medication for the study will be provided free of charge.Participants must be between the ages of 18 and 65 and have an onset of OCD at least 1 year prior to screening. In addition, participants must be taking a clinically effective dose of an SSRI for at least 3 months and must maintain their current dose throughout the study. Participants must not have a primary OCD symptom of hoarding.

02

Conditions studied

  • Obsessive-compulsive Disorder

Keywords

  • OCD
  • Obsessive-Compulsive Disorder
  • OCD treatment
03

In context

Compulsive Personality Disorder

367 studies on the registry are indexed under Compulsive Personality Disorder; 67 are open to participants now.

This study's planned enrollment of 24 is below the median of 37 across 306 interventional studies indexed under Compulsive Personality Disorder.

Browse Compulsive Personality Disorder studies →

Lead sponsor

Montefiore Medical Center is the lead sponsor of 402 studies on the registry; 70 are open to participants now.

Of its 81 completed or terminated interventional studies of FDA-regulated products, 73 (90%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

Males and Females 18-65 years of age diagnosed with OCD and currently taking SSRI medication(s)

Exclusion criteria

Exclusion Criteria:

major medical disorders

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
24 participants (estimated)

Interventions

  • Drugtopiramate
06

What researchers measure

Primary outcomes

  1. To evaluate the safety and efficacy of adjunctive topiramate vs. placebo in the treatment of OCD

07

Study locations

1 site
  • Mount Sinai School of Medicine
    New York, New York 10029, United States
08

References and documents

Publications

  • Berlin HA, Koran LM, Jenike MA, Shapira NA, Chaplin W, Pallanti S, Hollander E. Double-blind, placebo-controlled trial of topiramate augmentation in treatment-resistant obsessive-compulsive disorder. J Clin Psychiatry. 2011 May;72(5):716-21. doi: 10.4088/JCP.09m05266gre. Epub 2010 Aug 10. PubMed 20816027 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 30, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00211744
Lead sponsor
Montefiore Medical Center
Collaborators
Ortho-McNeil Pharmaceutical
Responsible party
Eric Hollander (Principal Investigator, Montefiore Medical Center) — Principal investigator
First posted
Sep 21, 2005
Start date
Aug 2004
Completion
Aug 2006
Last update
May 30, 2018

Study contacts

Erik Hollander, MD
principal investigator · Icahn School of Medicine at Mount Sinai
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2018. You cannot join it, but the record below documents what was studied.

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