Efficacy of Adding Topiramate to Current Treatment in Refractory Obsessive Compulsive Disorder (OCD)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-01-31

Study Completion Date

2019-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

SRI's are considered first-line treatments for OCD, however many patients continue to have significant symptoms despite an adequate trial of an SRI. Neuroimaging studies have shown that the glutamate neurological system is involved in OCD. This study will test the safety and efficacy of topiramate, a drug, which targets glutamate, in the treatment of OCD, where the OCD has been un-responsive, or partially responsive to regular SRI treatment.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Study to Determine the Efficacy and Safety of Adjunctive Topiramate in the Treatment of Obsessive-Compulsive Disorder

NCT00187928

Obsessive-Compulsive Disorder

COMPLETED PHASE3

Topiramate Augmentation in the Treatment of Obsessive-Compulsive Disorder

NCT00211744

Obsessive-compulsive Disorder

COMPLETED PHASE4

Efficacy of Adding Topiramate to Current Treatment in Treatment-Resistant Generalized Social Phobia (GSP)

NCT00182455

Social Phobia

TERMINATED PHASE4

Study of Memantine Augmentation in Severe Obsessive-Compulsive Disorder

NCT00869505

Obsessive-Compulsive Disorder

COMPLETED

Developing Effective Response Inhibition Training for Symptom Relief in OCD and Trichotillomania

NCT02059980

Obsessive Compulsive Disorder Trichotillomania

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Obsessive Compulsive Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Topiramate

Group Type EXPERIMENTAL

Topiramate

Intervention Type DRUG

25 mg - 400 mg/day x 12 weeks

2

placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

25 - 400 mg/day x 12 weeks

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Topiramate

25 mg - 400 mg/day x 12 weeks

Intervention Type DRUG

placebo

25 - 400 mg/day x 12 weeks

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Topomax

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Outpatient with primary DSM- IV OCD
* Completion of a 14-week open label trial of one the following SRI's: fluoxetine 80 mg/day, paroxetine 60 mg/day, fluvoxamine 300 mg/day, clomipramine 250 mg/day, sertraline 200 mg/day, citalopram 60 mg/day, escitalopram 30 mg/day and demonstrating a non or partial responses to SRI treatment (CGI-I of 3 or 4, Y-BOCS reduction of \< 35%)
* Stable (8 wks or longer) concurrent medications including benzodiazepines, sedative hypnotics, antipsychotics, and antidepressants.

Exclusion Criteria

* Any other primary DSM-IV diagnosis; DSM-IV criteria for body dysmorphic disorder, bipolar affective disorder, schizophrenia, psychotic disorder, current alcohol/substance abuse.
* A previous adequate trial of topiramate
* Comorbid major depressive disorder diagnosis which predates OCD diagnosis
* Cognitive behavioural therapy or additional psychotherapy in past four months
* Allergy or hypersensitivity to topiramate
* BMI \< 20
* History of kidney stones

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No