Bipolar DisorderPhase 3NCT00237289
Topiramate Versus Placebo as add-on Treatment in Patients With Bipolar Disorder in the Outpatient Setting
A Phase 3 study testing topiramate in people with Bipolar Disorder, run by Ortho-McNeil Neurologics, Inc..
Trial summary
The purpose of this study is to assess the efficacy and safety of adding topiramate as compared to placebo to the medications a patient with bipolar disorder is already taking (lithium or valproate) to see if adding topiramate will better control the patient's manic symptoms. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Bipolar Disorder
- What is being tested?
- topiramate
- How many people
- 287 participants
- Where
- No sites listed yet
- Study dates
- Oct 2001to Oct 2003
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed diagnosis of Bipolar Disorder Type I
- Total Young Mania Rating Scale (YMRS) score of 18 or higher
- Currently being treated with a mood stabilizer (lithium or valproate)
- Having a stable therapeutic dose of the mood stabilizer in their bloodstream
- Currently not requiring hospitalization
Who cannot join
- Patients taking an antidepressant or anti-seizure medication
- Hospitalized paitents
- Women who are pregnant or breast-feeding
- Women who are not using birth control
- Patients with history of drug or alcohol abuse
About this study
The purpose of this study is to assess the efficacy and safety of adding topiramate as compared to placebo to the medications a patient with bipolar disorder is already taking (lithium or valproate) to see if adding topiramate will better control the patient's manic symptoms.
Read the detailed description
Many patients with bipolar disorder (manic-depressive illness) require more than one medication to control their symptoms. This is a 12-week, multicenter, randomized, double-blind, placebo-controlled, parallel-groupd study to evalute the efficacy and safety of topiramate versus placebo as add-on therapy to lithium or valproate for the treatment of bipolar 1 disorder as an outpatient setting. These patients must already be taking either lithium or valproate for at least 6 weeks before the first visit and have been on the same dose of the mood stabilizer for at least 2 weeks before the first visit. Paitents will be randomized to receive either placebo or topiramate, an anti-seizure medication not approved for the treatment of bipolar disorder, in addition to their lithium or valporate. The study consists of 56-day titration (topiramate will be titrated up to 400mg per day or the maximum tolerated dose), 28-day continuation period, and 7 days of follow-up to taper off the medication. The study hypothesis is that topiramate will be more effective than placebo in the treatment of mania in type 1 bipolar disorder patients as measured by the Young Mania Rating Scale (YMRS) and will be well tolerated. YMRS is a questionnaire consisting of 11 items designed to assess severity of mania symptoms.
Patients will start taking topiramate 25 mg per day or placebo by mouth. Over the next 8 weeks, doses will be increased to up to 400 mg per day or to the maximum tolerated dose, whichever is lower. After the first 8 weeks, patients will stay at the established dose for the next 4 weeks.
- Conditions
- Bipolar Disorder
- Being tested
- topiramate
- Keywords
- Manic depression, Mania, Depression, Bipolar disorder, Psychosis
- Medical subject headings
- Bipolar Disorder, Mania, Depression, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
topiramateDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from baseline to final visit in the Young Mania Rating Scale total score. Safety evaluations (incidence of adverse events, physical exams, vital signs, clinical laboratory tests including thyroid function tests) throughout the study.
Secondary outcomes (1)
Changes from baseline to final visit in the Clinical Global Impressions Scale, Global Assessment Scale, Brief Psychiatric Rating Scale, and Montgomery-Asberg Depression Rating Scale. Rate of discontinuation due to efficacy failure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2005 (estimated)
- Study startOct 2001
- Study completionOct 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- 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
- Parallel groups
- Masking
- Double blind
- Enrolment
- 287 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ortho-McNeil Neurologics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Ortho McNeil Neurologics, Inc. Clinical Trial, Study director, Ortho-McNeil Neurologics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00237289
- Sponsor's protocol ID
- CR002653
- Status last verified
- Apr 2010
- First submitted
- 7 Oct 2005
- Last updated
- 19 May 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topiramate Versus Placebo as add-on Treatment in Patients With Bipolar Disorder in the Outpatient Setting
- ClinicalTrials.gov ID
- NCT00237289
- Acronym / sponsor ID
- CR002653
- Conditions
- Bipolar Disorder
- Keywords
- Manic depression, Mania, Depression, Bipolar disorder, Psychosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 287 participants (actual)
- Lead sponsor
- Ortho-McNeil Neurologics, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2001
- Study completion
- Oct 2003 (actual)
- First posted
- 12 Oct 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 assess the efficacy and safety of adding topiramate as compared to placebo to the medications a patient with bipolar disorder is already taking (lithium or valproate) to see if adding topiramate will better control the patient's manic symptoms.
Detailed description
Many patients with bipolar disorder (manic-depressive illness) require more than one medication to control their symptoms. This is a 12-week, multicenter, randomized, double-blind, placebo-controlled, parallel-groupd study to evalute the efficacy and safety of topiramate versus placebo as add-on therapy to lithium or valproate for the treatment of bipolar 1 disorder as an outpatient setting. These patients must already be taking either lithium or valproate for at least 6 weeks before the first visit and have been on the same dose of the mood stabilizer for at least 2 weeks before the first visit. Paitents will be randomized to receive either placebo or topiramate, an anti-seizure medication not approved for the treatment of bipolar disorder, in addition to their lithium or valporate. The study consists of 56-day titration (topiramate will be titrated up to 400mg per day or the maximum tolerated dose), 28-day continuation period, and 7 days of follow-up to taper off the medication. The study hypothesis is that topiramate will be more effective than placebo in the treatment of mania in type 1 bipolar disorder patients as measured by the Young Mania Rating Scale (YMRS) and will be well tolerated. YMRS is a questionnaire consisting of 11 items designed to assess severity of mania symptoms.
Patients will start taking topiramate 25 mg per day or placebo by mouth. Over the next 8 weeks, doses will be increased to up to 400 mg per day or to the maximum tolerated dose, whichever is lower. After the first 8 weeks, patients will stay at the established dose for the next 4 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Confirmed diagnosis of Bipolar Disorder Type I
- Total Young Mania Rating Scale (YMRS) score of 18 or higher
- Currently being treated with a mood stabilizer (lithium or valproate)
- Having a stable therapeutic dose of the mood stabilizer in their bloodstream
- Currently not requiring hospitalization
Key exclusion criteria (5 listed)
- Patients taking an antidepressant or anti-seizure medication
- Hospitalized paitents
- Women who are pregnant or breast-feeding
- Women who are not using birth control
- Patients with history of drug or alcohol abuse
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
Changes from baseline to final visit in the Young Mania Rating Scale total score. Safety evaluations (incidence of adverse events, physical exams, vital signs, clinical laboratory tests including thyroid function tests) throughout the study.
1 secondary outcome
Changes from baseline to final visit in the Clinical Global Impressions Scale, Global Assessment Scale, Brief Psychiatric Rating Scale, and Montgomery-Asberg Depression Rating Scale. Rate of discontinuation due to efficacy failure.
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 19 May 2011.
- Topiramate Versus Placebo as Add-On Treatment in Patients with Bipolar Disorder in the Outpatient SettingLink provided by the sponsor.
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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.
Ortho McNeil Neurologics, Inc. Clinical Trial study director
Ortho-McNeil Neurologics, Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing topiramate in people with Bipolar Disorder, run by Ortho-McNeil Neurologics, Inc..
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 5 inclusion and 5 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 19 May 2011. Status can change between updates, so confirm with the study contact before making plans.
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.
What does the primary outcome measure?
Changes from baseline to final visit in the Young Mania Rating Scale total score. Safety evaluations (incidence of adverse events, physical exams, vital signs, clinical laboratory tests including thyroid function tests) throughout the study.. It is what the study was designed to measure, not a finding.
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 19 May 2011.