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

A Study of Topiramate Augmentation in Serotonin Reuptake Inhibitor (SRI) -Refractory Obsessive Compulsive Disorder

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00182520

Enrollment

Registered

2005-09-16

Start date

2002-01-31

Completion date

2019-01-31

Last updated

2020-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obsessive Compulsive Disorder

Keywords

Treatment Refractory Obsessive Compulsive Disorder

Brief summary

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.

Interventions

DRUGTopiramate

25 mg - 400 mg/day x 12 weeks

DRUGplacebo

25 - 400 mg/day x 12 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Yale-Brown Obsessive Compulsive Scale (Y-BOCS)	12 weeks
Clinical Global Impression - Improvement ≤ 2	12 weeks

Secondary

Measure	Time frame
Beck Depression Inventory	12 weeks
Montgomery Asberg Depression Rating Scale	12 weeks
Self Report Y-BOCS	12 weeks
PI-SWUR Hoarding Scale	12 weeks
Sheehan Disability Scale	12 weeks

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026