Bipolar DisorderPhase 3NCT00035802
A Study to Evaluate the Safety and Effectiveness of Topiramate Compared to Placebo in the Treatment of Patients With Bipolar I Disorder
A Phase 3 study testing Topiramate in people with Bipolar Disorder and Affective Disorders, Psychotic, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
Trial summary
The purpose of this study is to determine the safety and efficacy of topiramate in adolescents with manic or mixed episodes of Bipolar I Disorder. Read more about this study
- Who is it for?
- Ages 13 to 17 years
- Conditions the study is for
- Bipolar Disorder, Affective Disorders, Psychotic, Mood Disorders
- What is being tested?
- Topiramate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 13 participants
- Where
- No sites listed yet
- Study dates
- Jan 2002to Apr 2002
- 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 13 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- DSM-IV diagnosis of Bipolar I Disorder (confirmed by the Kiddie-Schedule for Affective Disorders and Schizophrenia-Present and Lifetime version [K-SADS-P/L])
- YMRS score greater than or equal to 20
- General good health as determined by medical history, physical examination, and laboratory evaluations
- Ability to swallow tablets
- Patient's parent or guardian must be fully capable of monitoring the patient's disease process and compliance to treatment
- Parent(s) or legal guardian(s) must read and sign the informed consent form after the nature of the study has been fully explained and assent must be obtained from patients
Who cannot join
- DSM-IV Axis I disorder diagnoses of autistic disorder, schizophrenia, schizoaffective disorder, or other psychotic disorders not otherwise specified (NOS)
- DSM-IV diagnosis of alcohol or substance dependence, with the exception of nicotine or caffeine dependence, within the 3 months prior to baseline. Acute or intermittent substance abuse prior to screening will not be exclusionary, depending upon the clinical judgment of the investigator
- Chronic antidepressant treatment within 4 weeks of randomization (5 weeks for fluoxetine), use of psychostimulants in the 7 days prior to baseline, use of any other psychotropic medications within 3 days or 5 half-lives, whichever is less, prior to baseline, or requirement for treatment with other psychotropic drugs on an ongoing basis
- Weight less than 33 kg or current or past history of anorexia nervosa
- Serious or unstable medical or neurological conditions
About this study
Official title: A Randomized, Double-Blind, Multicenter, Placebo-Controlled 4-Week Study of the Safety and Efficacy of Topiramate in Adolescents With Acute Manic or Mixed Episodes of Bipolar I Disorder, With an Optional 6-Month Open-Label Extension
The purpose of this study is to determine the safety and efficacy of topiramate in adolescents with manic or mixed episodes of Bipolar I Disorder.
Read the detailed description
This is a 4-week study to evaluate the safety and effectiveness of topiramate compared to placebo in the treatment of Bipolar I Disorder with an optional 6-month open-label (OL) extension for qualified patients following completion of the study. On Days 1-28 patients will receive placebo or topiramate 2x/day by mouth except for the 1st and last doses which will be a single evening dose and a single morning dose, respectively. Study drug will be titrated in 100-mg increments to 400 mg/day and patients maintained on a stable dose through Day 28. During the OL extension phase, topiramate will be titrated over 5 days to 200 mg/day. After Day 7, topiramate may be tapered down to 100 mg/day or up to 600 mg/day, as clinically indicated.
- Being tested
- Topiramate, Placebo
- Keywords
- Bipolar, Mania, Pediatric, Children, Adolescent, Topiramate, Anticonvulsants, Central Nervous System Agents, Protective Agents, Neuroprotectiive Agents
- Medical subject headings
- Bipolar Disorder, Affective Disorders, Psychotic, Mood Disorders, Mental Disorders, Mania
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TopiramateDrug
Double-blind period: Up to 400 mg/day (two 100-mg tablets twice a day) for 28 days.
OL period: Up to 600 mg/day (three 100-mg tablets twice a day) for at least 6 months.
PlaceboDrug
Double-blind period: Equal number of matching placebo tablets for each of the topiramate tablet strengths twice a day for 28 days.
| Study group | Role | What they receive |
|---|---|---|
| 001 | Experimental | Topiramate Double-blind period: Up to 400 mg/day (two 100-mg tablets twice a day) for 28 days.
OL period: Up to 600 mg/day (three 100-mg tablets twice a day) for at least 6 months. Receives: Drug: Topiramate |
| 002 | Placebo comparator | Placebo Double-blind period: Equal number of matching placebo tablets for each of the topiramate tablet strengths twice a day for 28 days. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in total Young Mania Rating Scale (YMRS) score
Measured: Baseline to Day 28 (or last available observation prior to Day 28).
Secondary outcomes (3)
Change from baseline in Clinical Global Impression Scale (CGI-S) score
Measured: Baseline to Day 28 (or last available observation prior to Day 28).
Change from baseline in Children's Global Assessment Scale (C-GAS) score
Measured: Baseline to Day 28 (or last available observation prior to Day 28).
The number of patients continuing to meet Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria for manic or mixed episodes of Bipolar I Disorder
Measured: Day 28 (or last available observation prior to Day 28)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2002 (estimated)
- Study startJan 2002
- Study completionApr 2002
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 13 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
- NCT00035802
- Sponsor's protocol ID
- CR016867
- Other IDs
- TOPMAT-PDMD-009
- Status last verified
- Jun 2011
- First submitted
- 6 May 2002
- Last updated
- 27 Jun 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Multicenter, Placebo-Controlled 4-Week Study of the Safety and Efficacy of Topiramate in Adolescents With Acute Manic or Mixed Episodes of Bipolar I Disorder, With an Optional 6-Month Open-Label Extension
- ClinicalTrials.gov ID
- NCT00035802
- Acronym / sponsor ID
- CR016867
- Keywords
- Bipolar, Mania, Pediatric, Children, Adolescent, Topiramate, Anticonvulsants, Central Nervous System Agents
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.Industry (pharma, biotech, devices)
- Study start
- Jan 2002
- Study completion
- Apr 2002 (actual)
- First posted
- 7 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.
The purpose of this study is to determine the safety and efficacy of topiramate in adolescents with manic or mixed episodes of Bipolar I Disorder.
Detailed description
This is a 4-week study to evaluate the safety and effectiveness of topiramate compared to placebo in the treatment of Bipolar I Disorder with an optional 6-month open-label (OL) extension for qualified patients following completion of the study. On Days 1-28 patients will receive placebo or topiramate 2x/day by mouth except for the 1st and last doses which will be a single evening dose and a single morning dose, respectively. Study drug will be titrated in 100-mg increments to 400 mg/day and patients maintained on a stable dose through Day 28. During the OL extension phase, topiramate will be titrated over 5 days to 200 mg/day. After Day 7, topiramate may be tapered down to 100 mg/day or up to 600 mg/day, as clinically indicated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 001 | Experimental | Drug: TopiramateTopiramate Double-blind period: Up to 400 mg/day (two 100-mg tablets twice a day) for 28 days. OL period: Up to 600 mg/day (three 100-mg tablets twice a day) for at least 6 months. |
| 002 | Placebo comparator | Drug: PlaceboPlacebo Double-blind period: Equal number of matching placebo tablets for each of the topiramate tablet strengths twice a day for 28 days. |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- DSM-IV diagnosis of Bipolar I Disorder (confirmed by the Kiddie-Schedule for Affective Disorders and Schizophrenia-Present and Lifetime version [K-SADS-P/L])
- YMRS score greater than or equal to 20
- General good health as determined by medical history, physical examination, and laboratory evaluations
- Ability to swallow tablets
- Patient's parent or guardian must be fully capable of monitoring the patient's disease process and compliance to treatment
Key exclusion criteria (5 listed)
- DSM-IV Axis I disorder diagnoses of autistic disorder, schizophrenia, schizoaffective disorder, or other psychotic disorders not otherwise specified (NOS)
- DSM-IV diagnosis of alcohol or substance dependence, with the exception of nicotine or caffeine dependence, within the 3 months prior to baseline. Acute or intermittent substance abuse prior to screening will not be exclusionary, depending upon the clinical judgment of the investigator
- Chronic antidepressant treatment within 4 weeks of randomization (5 weeks for fluoxetine), use of psychostimulants in the 7 days prior to baseline, use of any other psychotropic medications within 3 days or 5 half-lives, whichever is less, prior to baseline, or requirement for treatment with other psychotropic drugs on an ongoing basis
- Weight less than 33 kg or current or past history of anorexia nervosa
- Serious or unstable medical or neurological conditions
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 |
|---|---|---|
| TopiramateDouble-blind period: Up to 400 mg/day (two 100-mg tablets twice a day) for 28 days. OL period: Up to 600 mg/day (three 100-mg tablets twice a day) for at least 6 months. | Drug | 001 |
| PlaceboDouble-blind period: Equal number of matching placebo tablets for each of the topiramate tablet strengths twice a day for 28 days. | Drug | 002 |
Primary outcome
Change from baseline in total Young Mania Rating Scale (YMRS) score
Time frame: Baseline to Day 28 (or last available observation prior to Day 28).
3 secondary outcomes
Change from baseline in Clinical Global Impression Scale (CGI-S) score
Time frame: Baseline to Day 28 (or last available observation prior to Day 28).
Change from baseline in Children's Global Assessment Scale (C-GAS) score
Time frame: Baseline to Day 28 (or last available observation prior to Day 28).
The number of patients continuing to meet Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria for manic or mixed episodes of Bipolar I Disorder
Time frame: Day 28 (or last available observation prior to Day 28)
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 27 Jun 2011.
Related trials for Bipolar Disorder
Not yet recruitingObservational study
Sleep Monitoring for Early Detection of Relapse in People With Schizophrenia or Bipolar Disorder Receiving Usual Treatment
Bipolar Disorder (BD), SCHIZOPHRENIA 1 (Disorder)
Recruiting
Safety and Feasibility of DBS for Bipolar Depression
Bipolar I Disorder, Bipolar Depression
Not yet recruiting
Compulsive Eating and Brain's Reward System in Different Pathologies
PARKINSON DISEASE (Disorder), Bipolar 1 Disorder
Not yet recruitingPhase 1
Pharmacokinetics and Relative Bioavailability of Intranasal vs Intramuscular Olanzapine in Healthy Adult Participants
Healthy Adult Participants
Recruiting
Affective Cognitive Training in Mood Disorders and High-risk Relatives
Major Depressive Disorder (MDD), Bipolar Disorder (BD)
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 and Affective Disorders, Psychotic, 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 6 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 27 Jun 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. Some participants in this study may receive a placebo. 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 in total Young Mania Rating Scale (YMRS) score (time frame: Baseline to Day 28 (or last available observation prior to Day 28).). 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 27 Jun 2011.