Topiramate Augmentation in the Treatment of Obsessive-Com... | NCT00211744

Studies
Topiramate Augmentation in the Treatment of Obsessive-Compulsive Disorder

NCT00211744

Sponsor

Montefiore Medical Center

Status

Completed

Last Update Posted

May 30, 2018Actual

Enrollment

24Estimated

Phase

Phase 4

Conditions

Obsessive-compulsive Disorder

Interventions

topiramate

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Not provided

Start Date

Aug 2004

Primary Completion Date

Not provided

Completion Date

Aug 2006Actual

First Submitted Date

Sep 13, 2005

First Submission Date that Met QC Criteria

Sep 13, 2005

First Posted Date

Sep 21, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 25, 2018

Last Update Posted Date

May 30, 2018Actual

Name	Class
Ortho-McNeil Pharmaceutical	INDUSTRY

Description Module

Brief 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).

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

24Estimated

Name	Type	Description	Arm Group Labels	Other Names
topiramate	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To evaluate the safety and efficacy of adjunctive topiramate vs. placebo in the treatment of OCD

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

major medical disorders

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Erik Hollander, MD	Icahn School of Medicine at Mount Sinai	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mount Sinai School of Medicine		New York	New York	10029	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
20816027	Derived	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.

ID	Term
D001008	Anxiety Disorders
D001523	Mental Disorders

ID	Term
D005632	Fructose
D006601	Hexoses
D009005	Monosaccharides
D000073893	Sugars
D002241