Obsessive-Compulsive DisorderPhase 3NCT00187928
Study to Determine the Efficacy and Safety of Adjunctive Topiramate in the Treatment of Obsessive-Compulsive Disorder
A Phase 3 study testing Topiramate in people with Obsessive-Compulsive Disorder, run by University of Florida at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obsessive-Compulsive Disorder
- What is being tested?
- Topiramate
- How many people
- 96 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2003to Mar 2006
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
- After full explanation of the study, subjects must demonstrate their willingness to participate by signing an informed consent form.
Who cannot join
- 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.
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- 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:
- symptomatic coronary artery or peripheral vascular disease
- malignancy or history of malignancy within the past 5 years, except basal cell carcinoma;
- any disease or condition that compromises the function of those body systems that could result in altered absorption, excess accumulation or impaired metabolism or excretion of topiramate;
- subjects who are considered to represent a significant risk of suicidal or violent behavior in the judgement of the Investigator
- Female subjects who are pregnant or lactating.
- Subjects who have not observed the designated washout periods for any of the prohibited medications outlined in the Concurrent Therapy section of the protocol.
- Subjects who in the opinion of the investigator should not be enrolled in the study because of the Precautions, Warnings or Contraindications sections of the topiramate package insert.
Trial locations and contacts
1 site in 1 country.
United States1 site
UF Health Science Center
Gainesville, Florida, 32608
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Determine the Efficacy and Safety of Adjunctive Topiramate in the Treatment of Obsessive-Compulsive Disorder
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.
Read the detailed description
This is a multicenter, outpatient, randomized, double-blind, placebo-controlled, parallel-group, study designed to evaluate the safety and efficacy of adjunctive topiramate in treating subjects with OCD. The study consists of a washout/screening phase, a double-blind treatment phase of 12 weeks, a taper period of approximately 7 days. Upon successful completion of the washout/screening phase subjects will be randomized into 1 of 2 treatment groups: topiramate up to 400 mg/day or placebo. A placebo control will be used to establish the frequency and magnitude of changed in clinical endpoints that may occur in the absence of active treatment.
During the double-blind phase, subjects will be seen weekly for the first two weeks and then every other week for the remainder of the double-blind phase. Study medication will be titrated over the 8-week titration period up to 400mg/day or the subject's maximum tolerated dose. After the titration period, the dose will remain stable for the maintenance period during which visits will occur every 14 days. At the completion of the maintenance period, subjects will taper their study medication over the next 7 days.
This study will be conducted in up to 96 subjects with a diagnosis of OCD with an onset at least 1 year prior to screening supported by the SCID-I. Forty-eight subjects will be assigned to topiramate and 48 will be assigned to placebo.
- Conditions
- Obsessive-Compulsive Disorder
- Being tested
- Topiramate
- Keywords
- Obsessive-Compulsive Disorder, Obsessions, Compulsions, Adjunctive treatment
- Medical subject headings
- Obsessive-Compulsive Disorder, Obsessive Behavior, Compulsive Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TopiramateDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startJan 2003
- Primary completionMar 2006
- Study completionMar 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obsessive-Compulsive DisorderStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Enrolment
- 96 participants
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- Ortho-McNeil Pharmaceutical
- Responsible party
- Sponsor
- Investigators
- Herbert E Ward, MD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00187928
- Sponsor's protocol ID
- CAPSS-217
- Status last verified
- Oct 2011
- First submitted
- 15 Sep 2005
- Last updated
- 5 Oct 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Determine the Efficacy and Safety of Adjunctive Topiramate in the Treatment of Obsessive-Compulsive Disorder
- ClinicalTrials.gov ID
- NCT00187928
- Acronym / sponsor ID
- CAPSS-217
- Conditions
- Obsessive-Compulsive Disorder
- Keywords
- Obsessive-Compulsive Disorder, Obsessions, Compulsions, Adjunctive treatment
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- Ortho-McNeil Pharmaceutical
- Study start
- Jan 2003
- Primary completion
- Mar 2006 (actual)
- Study completion
- Mar 2006 (actual)
- First posted
- 16 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a multicenter, outpatient, randomized, double-blind, placebo-controlled, parallel-group, study designed to evaluate the safety and efficacy of adjunctive topiramate in treating subjects with OCD. The study consists of a washout/screening phase, a double-blind treatment phase of 12 weeks, a taper period of approximately 7 days. Upon successful completion of the washout/screening phase subjects will be randomized into 1 of 2 treatment groups: topiramate up to 400 mg/day or placebo. A placebo control will be used to establish the frequency and magnitude of changed in clinical endpoints that may occur in the absence of active treatment.
During the double-blind phase, subjects will be seen weekly for the first two weeks and then every other week for the remainder of the double-blind phase. Study medication will be titrated over the 8-week titration period up to 400mg/day or the subject's maximum tolerated dose. After the titration period, the dose will remain stable for the maintenance period during which visits will occur every 14 days. At the completion of the maintenance period, subjects will taper their study medication over the next 7 days.
This study will be conducted in up to 96 subjects with a diagnosis of OCD with an onset at least 1 year prior to screening supported by the SCID-I. Forty-eight subjects will be assigned to topiramate and 48 will be assigned to placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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.
Key exclusion criteria (22 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Topiramate | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Herbert E Ward, MD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Topiramate in people with Obsessive-Compulsive Disorder, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2011.