Bipolar DisorderNCT01428518
Special Drug Use Investigation for LAMICTAL Bipolar
An observational study of Bipolar Disorder, run by GlaxoSmithKline.
Trial summary
This post-marketing surveillance study is designed to collect and assess information on safety and effectiveness of lamotrigine tablets in patients with bipolar disorder in routine clinical practice. ("LAMICTAL" is a trademark of the GlaxoSmithKline group of companies.) Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Bipolar Disorder
- What is being tested?
- Lamotrigine tablets
- Type of treatment
- Pill or oral medicine
- How many people
- 1,036 participants
- Where
- No sites listed yet
- Study dates
- Nov 2011to Jan 2016
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Japanese patients with bipolar disorder prescribed lamotrigine tablets for the first time
Who may be able to join
- Patients with bipolar disorder
- Patients treated with lamotrigine tablets for the first time
Who cannot join
- Not applicable
About this study
This post-marketing surveillance study is designed to collect and assess information on safety and effectiveness of lamotrigine tablets in patients with bipolar disorder in routine clinical practice.
("LAMICTAL" is a trademark of the GlaxoSmithKline group of companies.)
- Conditions
- Bipolar Disorder
- Being tested
- Lamotrigine tablets
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lamotrigine tabletsDrug
Administered according to the prescribing information in the locally approved label by the authorities.
| Study group | Role | What they receive |
|---|---|---|
| Patients with bipolar disorder | Patients with bipolar disorder prescribed lamotrigine tablets for the first time Receives: Drug: Lamotrigine tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with any adverse drug reaction
Measured: 1 year
Secondary outcomes (4)
Occurrence of skin disorder
Measured: 1 year
Occurrence of suicide-related event and self injurious behaviour
Measured: 1 year
Occurrence of harming others
Measured: 1 year
Occurrence of withdrawal symptoms after treatment
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2011 (estimated)
- Study startNov 2011
- Primary completionJan 2016
- Study completionJan 2016
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.
- More trials run by GlaxoSmithKlineThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,036 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01428518
- Sponsor's protocol ID
- 115324
- Status last verified
- Apr 2016
- First submitted
- 1 Sep 2011
- Last updated
- 25 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Special Drug Use Investigation for LAMICTAL Bipolar
- ClinicalTrials.gov ID
- NCT01428518
- Acronym / sponsor ID
- 115324
- Conditions
- Bipolar Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,036 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Nov 2011
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 5 Sep 2011 (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 post-marketing surveillance study is designed to collect and assess information on safety and effectiveness of lamotrigine tablets in patients with bipolar disorder in routine clinical practice.
("LAMICTAL" is a trademark of the GlaxoSmithKline group of companies.)
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with bipolar disorder | – | Drug: Lamotrigine tabletsPatients with bipolar disorder prescribed lamotrigine tablets for the first time |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Japanese patients with bipolar disorder prescribed lamotrigine tablets for the first time
Key inclusion criteria (2 listed)
- Patients with bipolar disorder
- Patients treated with lamotrigine tablets for the first time
Key exclusion criteria (1 listed)
- Not applicable
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 |
|---|---|---|
| Lamotrigine tabletsAdministered according to the prescribing information in the locally approved label by the authorities. | Drug | Patients with bipolar disorder |
Primary outcome
Number of patients with any adverse drug reaction
Time frame: 1 year
4 secondary outcomes
Occurrence of skin disorder
Time frame: 1 year
Occurrence of suicide-related event and self injurious behaviour
Time frame: 1 year
Occurrence of harming others
Time frame: 1 year
Occurrence of withdrawal symptoms after treatment
Time frame: 1 year
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 25 Apr 2016.
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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.
GSK Clinical Trials study director
GlaxoSmithKline
Questions about this trial
What is this clinical trial studying?
An observational study of Bipolar Disorder, run by GlaxoSmithKline.
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 2 inclusion and 1 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 25 Apr 2016. 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.
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?
Number of patients with any adverse drug reaction (time frame: 1 year). 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 25 Apr 2016.