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

NCT00187928 | Completed Phase 3 DMC

• 1 other identifier: CAPSS-217
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine if a drug called topiramate is safe and effective as an add-on therapy in the treatment of Obsessive-Compulsive Disorder (OCD). Topiramate is an investigational drug for OCD, which means it has not been approved by the U.S. Food and Drug Administration (FDA). Topiramate has been approved as an add-on therapy for adults and children with partial onset seizures or generalized tonic-clonic seizures, and for patients 2 years of age and older with a severe form of epilepsy called Lennox-Gastaut Syndrome. Up to 96 subjects will be enrolled in this study. This study consists of three phases: Washout/Screening Phase, Double-Blind Phase, and Taper Phase. The total expected length of your participation in the study is approximately four months.

Conditions

Obsessive-Compulsive Disorder

Keywords

Obsessive-Compulsive Disorder; Obsessions; Compulsions; Adjunctive treatment

Interventions

Topiramate DRUG

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must have onset of OCD at least 1 year prior to Screening (Visit 1) and must be supported by the Structured Clinical Interview for DSM-IV for Axis I Disorders (SCID-I).
• Subjects must be taking a clinically effective dose of a Selective Serotonin Reuptake Inhibitor (SSRI) (i.e., Paroxetine, Sertraline, Fluvoxamine, Fluoxetine, Citalopram) for at least 12 weeks. Subjects must be on their current dose for at least 6 weeks and must maintain their current dose throughout the study.
• Subjects must have stable OCD symptoms and must have a minimum severity of greater than or equal to 18 on Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) or a minimum score of greater than or equal to 10 on questions one through five if the subject has obsessions without compulsions at Visit 2 (Baseline).
• Subjects must be between 18 and 65 years of age, inclusive.
• Subjects can be male or female and must be in generally good health as confirmed by medical history, baseline psychiatric history and physical examination, including vital signs. Baseline laboratory values must be within normal limits, or considered clinically insignificant by the investigator.
• Subjects must have observed the designated washout periods for prohibited medications outlined under the Concomitant Therapy section of this protocol.
• Subjects must have a negative urine drug screening (phencyclidine, cocaine, amphetamines, tetrahydrocannabinol, and opiates) at Visit 1.
• If female, the subject must:
• be postmenopausal for at least one year, or
• have had a hysterectomy or bilateral tubal ligation with resection or otherwise be incapable of pregnancy, or
• have practiced one of the following methods of contraception for at least one month prior to study entry: hormonal contraceptives, spermicide and barrier, intrauterine device, spousal/partner sterility or
• be practicing abstinence and agree to continue abstinence or to use an acceptable method of contraception (as listed above) should sexual activity commence.
• Female subjects of childbearing potential must have negative urine pregnancy test up to 7 days prior to Visit 2 (Day 1).
• Subjects must be able to take oral medication, adhere to medication regimens and be willing to return for regular visits.
• Subjects must be able to read and comprehend written instructions and willing to complete all scales and inventories required by this protocol.

You may not qualify if:

• Subjects whose primary OCD symptom is hoarding. Hoarding is the most disabling and most distressing or clinically significant symptom.
• Subjects who have a current or recent (within 6 months of the start of study medication)DSM-IV-TR diagnosis of substance dependence or abuse (with the exception of nicotine or caffeine dependence).
• Subjects with a current or lifetime DSM-IV-TR diagnosis of bipolar disorders, or other psychotic disorder as defined by DSM-IV-TR.
• Subjects with a history of personality disorder (e.g., schizotypal or borderline) considered by the investigator to likely interfere with assessment or compliance with treatment.
• Subjects who are currently receiving behavioral therapy under medical supervision.
• Subjects with prior non-response to topiramate in the opinion of the investigator for the treatment of OCD following an adequate trial.
• Subjects who have previously been treated with topiramate and discontinued treatment due to an adverse event or subjects with a history of allergic hypersensitivity reaction to topiramate.
• Subjects with clinically unstable disease: cardiovascular, renal, hepatic, gastrointestinal, pulmonary, metabolic, endocrine or other systemic disease that could interfere with the diagnosis, treatment, or assessment of OCD.
• Subjects with a history of seizures.
• Subjects with a history of nephrolithiasis.
• Subjects with an estimated creatinine clearance of less than or equal to 60 mL/min.
• Subjects who have SGOT and/or SGPT levels greater than 2 times the upper limit of the normal range at Visit 1.
• Subjects who have active liver disease.
• Subjects with progressive or degenerative neurologic disorders (e.g., multiple sclerosis).
• Subjects known to have clinically significant medical conditions, including but not limited to:

Sponsors & Collaborators

• University of Florida: lead
• Ortho-McNeil Pharmaceutical: collaborator

Study Sites (1)

UF Health Science Center

Gainesville, Florida, 32608, United States

Location

MeSH Terms

Conditions

Obsessive-Compulsive Disorder; Obsessive Behavior; Compulsive Behavior

Interventions

Topiramate

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders; Behavioral Symptoms; Behavior; Impulsive Behavior

Intervention Hierarchy (Ancestors)

Fructose; Hexoses; Monosaccharides; Sugars; Carbohydrates; Ketoses

Study Officials

• Herbert E Ward, MD

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2005
• First Posted: September 16, 2005
• Study Start: January 1, 2003
• Primary Completion: March 1, 2006
• Study Completion: March 1, 2006
• Last Updated: October 5, 2011

Record last verified: 2011-10

Locations

US (1)