Bipolar DisorderPhase 3NCT00037674
A Study on the Safety and Efficacy of Topiramate in the Treatment of Patients With Bipolar I Disorder
A Phase 3 study testing Topiramate in people with Bipolar Disorder, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
Trial summary
This primary purpose of this study is to evaluate the safety and efficacy of topiramate compared with lithium or placebo in the treatment of acute manic or mixed episodes in patients with Bipolar I Disorder. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Bipolar Disorder
- What is being tested?
- Topiramate
- How many people
- 434 participants
- Where
- No sites listed yet
- Study dates
- Jan 2001to May 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosis of Bipolar I Disorder by criteria of Diagnostic and Statistical Manual of Mental Diseases, 4th edition (DSM-IV) confirmed by the Structured Clinical Interview for DSM-IV Axis I Disorders (SCID-I
- )
- At least one previous manic or mixed episode
- Meeting minimum severity criteria (a Young Mania Rating Scale [YMRS] score of >=20 at screening and baseline visits) for the current acute manic or mixed episode
- Females must be postmenopausal, surgically sterile, or using adequate contraceptive measures, and have a negative pregnancy test
Who cannot join
- DSM-IV diagnosis of alcohol or substance dependence (with the exception of nicotine or caffeine dependence)
- DSM-IV Axis I diagnosis of schizoaffective disorder or impulse control disorder
- Experienced a manic episode while taking an antidepressant or psychostimulant drug
- Known hypersensitivity to topiramate or previously participated in a topiramate study
About this study
Official title: A Randomized, Double-Blind, Multicenter, Placebo-Controlled 12-Week Study of the Safety and Efficacy of Two Doses of Topiramate for the Treatment of Acute Manic or Mixed Episodes in Patients With Bipolar I Disorder With an Optional Open-Label Extension
This primary purpose of this study is to evaluate the safety and efficacy of topiramate compared with lithium or placebo in the treatment of acute manic or mixed episodes in patients with Bipolar I Disorder.
Read the detailed description
This is a randomized, double-blind, placebo- and active-controlled study to evaluate the effectiveness of two dose levels of topiramate (200 and 400 milligrams/day) compared with lithium and placebo in the treatment of acute manic or mixed episodes in patients with Biplar I Disorder. The trial consists of 3 phases: a screening period; double-blind treatment for 12 weeks; and an optional open-label period of at least 6 months. Efficacy assessments include the change from baseline to Day 21 for the total Young Mania Rating Scale (YMRS) score. Also included as efficacy assessments during the 12 week study are the Global Assessment Scale (GAS), Montgomery-Åsberg Depression Rating Scale (MADRS), Brief Psychiatric Rating Scale (BPRS), Clinical Global Impressions (CGI), and health-related quality of life measures at specified time intervals. Safety assessments include evaluation of adverse events throughout the study, rate of withdrawal from the study due to adverse events, and vital signs (blood pressure and pulse) througout the study, as well as changes in clinical laboratory tests (hematology, chemistry, urinalysis), electrocardiograms (ECGs), and physical examinations at specified times. The study hypothesis is that the change from baseline in Young Mania Rating Scale (YMSR) total score at Day 21 will be significantly better for the topiramate groups than for the placebo group and that the study drug will be well tolerated by the patients. Topiramate: oral tablets (50 milligrams[mg]); increasing from once daily (50mg) to 3-times daily; target total daily dose 200mg or 400mg, maintained through Week 12. Lithium: oral capsules (300mg); increasing from once daily (300mg) to three-times daily; target total daily dose 1500-1800 mg.
- Conditions
- Bipolar Disorder
- Being tested
- Topiramate
- Keywords
- Bipolar Disorder, Bipolar, Mania, Topiramate, Lithium
- Medical subject headings
- Bipolar Disorder, Mania
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.
Change from baseline to Day 21 in the total Young Mania Rating Scale (YMRS) score.
Secondary outcomes (1)
Change from baseline to Day 21 and Week 12 in scores of MADRS, BPRS, CGI, and GAS. Response to treatment, indicated by no longer meeting DSM-IV criteria for manic/mixed episode. Incidence of adverse events monitored throughout the study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2002 (estimated)
- Study startJan 2001
- Study completionMay 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
- 434 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial, Study director, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00037674
- Sponsor's protocol ID
- CR003199
- Status last verified
- Jan 2011
- First submitted
- 20 May 2002
- Last updated
- 18 May 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Multicenter, Placebo-Controlled 12-Week Study of the Safety and Efficacy of Two Doses of Topiramate for the Treatment of Acute Manic or Mixed Episodes in Patients With Bipolar I Disorder With an Optional Open-Label Extension
- ClinicalTrials.gov ID
- NCT00037674
- Acronym / sponsor ID
- CR003199
- Conditions
- Bipolar Disorder
- Keywords
- Bipolar Disorder, Bipolar, Mania, Topiramate, Lithium
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 434 participants (actual)
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.Industry (pharma, biotech, devices)
- Study start
- Jan 2001
- Study completion
- May 2003 (actual)
- First posted
- 21 May 2002 (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.
This primary purpose of this study is to evaluate the safety and efficacy of topiramate compared with lithium or placebo in the treatment of acute manic or mixed episodes in patients with Bipolar I Disorder.
Detailed description
This is a randomized, double-blind, placebo- and active-controlled study to evaluate the effectiveness of two dose levels of topiramate (200 and 400 milligrams/day) compared with lithium and placebo in the treatment of acute manic or mixed episodes in patients with Biplar I Disorder. The trial consists of 3 phases: a screening period; double-blind treatment for 12 weeks; and an optional open-label period of at least 6 months. Efficacy assessments include the change from baseline to Day 21 for the total Young Mania Rating Scale (YMRS) score. Also included as efficacy assessments during the 12 week study are the Global Assessment Scale (GAS), Montgomery-Åsberg Depression Rating Scale (MADRS), Brief Psychiatric Rating Scale (BPRS), Clinical Global Impressions (CGI), and health-related quality of life measures at specified time intervals. Safety assessments include evaluation of adverse events throughout the study, rate of withdrawal from the study due to adverse events, and vital signs (blood pressure and pulse) througout the study, as well as changes in clinical laboratory tests (hematology, chemistry, urinalysis), electrocardiograms (ECGs), and physical examinations at specified times. The study hypothesis is that the change from baseline in Young Mania Rating Scale (YMSR) total score at Day 21 will be significantly better for the topiramate groups than for the placebo group and that the study drug will be well tolerated by the patients. Topiramate: oral tablets (50 milligrams[mg]); increasing from once daily (50mg) to 3-times daily; target total daily dose 200mg or 400mg, maintained through Week 12. Lithium: oral capsules (300mg); increasing from once daily (300mg) to three-times daily; target total daily dose 1500-1800 mg.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of Bipolar I Disorder by criteria of Diagnostic and Statistical Manual of Mental Diseases, 4th edition (DSM-IV) confirmed by the Structured Clinical Interview for DSM-IV Axis I Disorders (SCID-I
- )
- At least one previous manic or mixed episode
- Meeting minimum severity criteria (a Young Mania Rating Scale [YMRS] score of >=20 at screening and baseline visits) for the current acute manic or mixed episode
- Females must be postmenopausal, surgically sterile, or using adequate contraceptive measures, and have a negative pregnancy test
Key exclusion criteria (4 listed)
- DSM-IV diagnosis of alcohol or substance dependence (with the exception of nicotine or caffeine dependence)
- DSM-IV Axis I diagnosis of schizoaffective disorder or impulse control disorder
- Experienced a manic episode while taking an antidepressant or psychostimulant drug
- Known hypersensitivity to topiramate or previously participated in a topiramate study
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
Change from baseline to Day 21 in the total Young Mania Rating Scale (YMRS) score.
1 secondary outcome
Change from baseline to Day 21 and Week 12 in scores of MADRS, BPRS, CGI, and GAS. Response to treatment, indicated by no longer meeting DSM-IV criteria for manic/mixed episode. Incidence of adverse events monitored throughout the study.
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 18 May 2011.
- A Study of the Safety and Efficacy of Topiramate in the Treatment of Patients with Bipolar I DisorderLink 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.
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial study director
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Topiramate in people with Bipolar Disorder, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
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 4 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 18 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?
Change from baseline to Day 21 in the total Young Mania Rating Scale (YMRS) score.. 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 18 May 2011.