Bipolar DisorderPhase 4NCT00181844
Lamotrigine for the Treatment of Mania in Youth Ages 6-17 With Bipolar Disorder
A Phase 4 study testing lamotrigine in people with Bipolar Disorder and Mania, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The main objective of this study is to assess the effectiveness and safety of lamotrigine in the treatment of youth with bipolar and bipolar spectrum disorder. This is an exploratory, 12-week, open-label treatment period, pilot study, of youth ages 6-17, who meet the DSM-IV diagnostic criteria for bipolar I, bipolar… Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Bipolar Disorder, Mania
- What is being tested?
- lamotrigine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2005to Apr 2008
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Male or female subjects, 6-17 years of age.
- Subjects must have a DSM-IV diagnosis of bipolar I, bipolar II disorder or bipolar spectrum disorder and currently displaying manic, hypomanic, or mixed symptoms (with or without psychotic features) according to the DSM-IV based on clinical assessment and confirmed by structured diagnostic interview (Kiddie Schedule of Affective Disorders and Schizophrenia Epidemiological Version. Bipolar Spectrum Disorder (or sub-threshold bipolar disorder) is operationalized as having severe mood disturbance, which meets DSM-IV Criteria A for bipolar disorder but meet fewer elements in criteria B (only require 2 items for elation category and 3 for irritability).
- Subjects and their legal representative must have a level of understanding sufficient to communicate intelligently with the investigator and study coordinator, and to cooperate with all tests and examinations required by the protocol.
- Subjects and their legal representative must be considered reliable.
- Each subject and his/her authorized legal representative must understand the nature of the study. The subject's authorized legal representative must sign an informed consent document and the subject must sign an informed assent document.
- Subjects must have an initial score on the Y-MRS total score of at least 20.
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- Subject must be able to participate in mandatory blood draws.
- Subject must be able to swallow pills.
- Subjects with comorbid ADHD, ODD, CD, anxiety and depressive disorders will be allowed to participate in the study provided they do not meet for any of the exclusionary criteria.
- For concomitant stimulant therapy used to treat ADHD, subjects must have been on a stable dose of the medication for 1 month prior to study enrollment. The dose of the stimulant therapy will not change throughout the duration of the study.
Who cannot join
- Investigator and his/her immediate family; defined as the investigator's spouse, parent, child, grandparent, or grandchild.
- Subjects unable to swallow pills.
- Serious, unstable illness including hepatic, renal, gastroenterological, respiratory, cardiovascular (including ischemic heart disease), endocrinologic, neurologic, immunologic, or hematologic disease.
- History of sensitivity to lamotrigine or known, severe allergies or multiple adverse drug reactions.
- History of previous bone marrow depression.
- History of serious rashes.
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- DSM-IV substance (except nicotine or caffeine) dependence within past 3 months.
- Judged clinically to be at serious suicidal risk.
- Any other concomitant medication with primarily central nervous system activity other than specified in Concomitant Medication portion of the protocol.
- A non-responder or a history of intolerance to lamotrigine in an adequate trial (2 months or more at an adequate dose) as determined by the clinician.
- Current diagnosis of schizophrenia.
- Pregnant or nursing females.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Cambridge, Massachusetts, 02138
About this study
Official title: A Pilot Open Study of the Safety and Effectiveness of Lamotrigine for the Treatment of Mania in Youth Ages 6-17 With Bipolar I, Bipolar II, and Bipolar Spectrum Disorders
The main objective of this study is to assess the effectiveness and safety of lamotrigine in the treatment of youth with bipolar and bipolar spectrum disorder. This is an exploratory, 12-week, open-label treatment period, pilot study, of youth ages 6-17, who meet the DSM-IV diagnostic criteria for bipolar I, bipolar II, or bipolar spectrum disorder. The study results will be used to generate hypotheses for a larger randomized controlled clinical trial. Based on the available literature in adults with bipolar disorder, we hypothesized that lamotrigine will be efficacious and well tolerated in youth with pediatric bipolar and bipolar spectrum disorders.
Read the detailed description
Lamotrigine is a new generation antiepileptic drug, approved by the FDA in 2003 for the maintenance treatment of adults with Bipolar I disorder to delay the time to occurrence of mood episodes (depression, mania, hypomania,\& mixed episodes) in patients treated for acute mood episodes with standard therapy. Recent studies have shown that Lamotrigine maintenance treatment was more robust in bipolar depression.
The study includes 1) use of a 12-week design to document the response rate 2) assessment of the impact of Lamotrigine on functional capacities and cognition, 3) careful assessment of safety and tolerability.
- Conditions
- Bipolar Disorder, Mania
- Being tested
- lamotrigine
- Keywords
- bipolar disorder, lamotrigine, children, mania
- 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.
lamotrigineDrug
Also called Lamictal
Open-label, flexible-dose, BID treatment of lamotrigine (Lamictal). For children <12 years, dosing began at 0.35 mg/kg/day, divided in 2 doses, rounded down to nearest 5mg, to be increased weekly depending on response and tolerability to maintenance dose of 5-15 mg/kg/day (maximum 400 mg/day in 2 divided doses). For children ≥12 years, dose began at 25 mg/day in 1 dose, to be increased weekly depending on response and tolerability to maintenance dose of 300-500 mg/day in 2 divided doses.
| Study group | Role | What they receive |
|---|---|---|
| Lamotrigine | Experimental | Not described Receives: Drug: lamotrigine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Mania Symptoms Assessed by Young Mania Rating Scale (YMRS)
Mean reduction in YMRS score at endpoint/LOCF. This is a scale to measure symptoms of mania in children and adolescents. 11 items are rated from 0-4 (7 items) or 0-8 (4 items). The minimum (least severe) total score is 0, and maximum (most severe) total score is 60.
Measured: baseline to 12 weeks
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 2005
- Primary completionFeb 2008
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Janet Wozniak, MD, Massachusetts General Hospital
- Investigators
- Janet Wozniak, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00181844
- Sponsor's protocol ID
- 2004-P-001419
- Status last verified
- Mar 2012
- First submitted
- 13 Sep 2005
- Last updated
- 6 Apr 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Open Study of the Safety and Effectiveness of Lamotrigine for the Treatment of Mania in Youth Ages 6-17 With Bipolar I, Bipolar II, and Bipolar Spectrum Disorders
- ClinicalTrials.gov ID
- NCT00181844
- Acronym / sponsor ID
- 2004-P-001419
- Conditions
- Bipolar Disorder, Mania
- Keywords
- bipolar disorder, lamotrigine, children, mania
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Jan 2005
- Primary completion
- Feb 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 16 Sep 2005 (estimated)
- Results
- Posted 6 Apr 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main objective of this study is to assess the effectiveness and safety of lamotrigine in the treatment of youth with bipolar and bipolar spectrum disorder. This is an exploratory, 12-week, open-label treatment period, pilot study, of youth ages 6-17, who meet the DSM-IV diagnostic criteria for bipolar I, bipolar II, or bipolar spectrum disorder. The study results will be used to generate hypotheses for a larger randomized controlled clinical trial. Based on the available literature in adults with bipolar disorder, we hypothesized that lamotrigine will be efficacious and well tolerated in youth with pediatric bipolar and bipolar spectrum disorders.
Detailed description
Lamotrigine is a new generation antiepileptic drug, approved by the FDA in 2003 for the maintenance treatment of adults with Bipolar I disorder to delay the time to occurrence of mood episodes (depression, mania, hypomania,\& mixed episodes) in patients treated for acute mood episodes with standard therapy. Recent studies have shown that Lamotrigine maintenance treatment was more robust in bipolar depression.
The study includes 1) use of a 12-week design to document the response rate 2) assessment of the impact of Lamotrigine on functional capacities and cognition, 3) careful assessment of safety and tolerability.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lamotrigine | Experimental | Drug: lamotrigine |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- Male or female subjects, 6-17 years of age.
- Subjects must have a DSM-IV diagnosis of bipolar I, bipolar II disorder or bipolar spectrum disorder and currently displaying manic, hypomanic, or mixed symptoms (with or without psychotic features) according to the DSM-IV based on clinical assessment and confirmed by structured diagnostic interview (Kiddie Schedule of Affective Disorders and Schizophrenia Epidemiological Version. Bipolar Spectrum Disorder (or sub-threshold bipolar disorder) is operationalized as having severe mood disturbance, which meets DSM-IV Criteria A for bipolar disorder but meet fewer elements in criteria B (only require 2 items for elation category and 3 for irritability).
- Subjects and their legal representative must have a level of understanding sufficient to communicate intelligently with the investigator and study coordinator, and to cooperate with all tests and examinations required by the protocol.
- Subjects and their legal representative must be considered reliable.
- Each subject and his/her authorized legal representative must understand the nature of the study. The subject's authorized legal representative must sign an informed consent document and the subject must sign an informed assent document.
Key exclusion criteria (12 listed)
- Investigator and his/her immediate family; defined as the investigator's spouse, parent, child, grandparent, or grandchild.
- Subjects unable to swallow pills.
- Serious, unstable illness including hepatic, renal, gastroenterological, respiratory, cardiovascular (including ischemic heart disease), endocrinologic, neurologic, immunologic, or hematologic disease.
- History of sensitivity to lamotrigine or known, severe allergies or multiple adverse drug reactions.
- History of previous bone marrow depression.
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 |
|---|---|---|
| lamotrigineAlso: LamictalOpen-label, flexible-dose, BID treatment of lamotrigine (Lamictal). For children <12 years, dosing began at 0.35 mg/kg/day, divided in 2 doses, rounded down to nearest 5mg, to be increased weekly depending on response and tolerability to maintenance dose of 5-15 mg/kg/day (maximum 400 mg/day in 2 divided doses). For children ≥12 years, dose began at 25 mg/day in 1 dose, to be increased weekly depending on response and tolerability to maintenance dose of 300-500 mg/day in 2 divided doses. | Drug | Lamotrigine |
Primary outcome
Change of Mania Symptoms Assessed by Young Mania Rating Scale (YMRS)
Time frame: baseline to 12 weeks
Mean reduction in YMRS score at endpoint/LOCF. This is a scale to measure symptoms of mania in children and adolescents. 11 items are rated from 0-4 (7 items) or 0-8 (4 items). The minimum (least severe) total score is 0, and maximum (most severe) total score is 60.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Janet Wozniak, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing lamotrigine in people with Bipolar Disorder and Mania, run by Massachusetts General Hospital 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 10 inclusion and 12 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 6 Apr 2012. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Apr 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 of Mania Symptoms Assessed by Young Mania Rating Scale (YMRS) (time frame: baseline to 12 weeks). 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 6 Apr 2012.