Last updated: 11/07/2018 09:10:58
Special Drug Use Investigation for LAMICTAL Bipolar
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
Official title: Special Drug Use Investigation for LAMICTAL Bipolar
Trial description: 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.)
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Number of patients with any adverse drug reaction
Timeframe: 1 year
Secondary outcomes:
Occurrence of skin disorder
Timeframe: 1 year
Occurrence of suicide-related event and self injurious behaviour
Timeframe: 1 year
Occurrence of harming others
Timeframe: 1 year
Occurrence of withdrawal symptoms after treatment
Timeframe: 1 year
Interventions:
Drug: Lamotrigine tablets
Enrollment:
1036
Observational study model:
Case-Only
Primary completion date:
Not applicable
Time perspective:
Prospective
Clinical publications:
Takeshi Terao, Atsuko Ishida, Toshifumi Kimura,Mitsuhiro Yoshida, Terufumi Hara. Assessment of safety and efficacy of lamotrigine over the course of 1-year observation in Japanese patients with bipolar disorder: Post-marketing surveillance study report. Neuropsychiatr Dis Treat. 2017;13:1441—1448
Medical condition
Bipolar Disorder
Product
lamotrigine
Collaborators
Not applicable
Study date(s)
November 2011 to January 2016
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
Not applicable
Accepts healthy volunteers
No
- Patients with bipolar disorder
- Patients treated with lamotrigine tablets for the first time
- Not applicable
Inclusion and exclusion criteria
Inclusion criteria:
- Patients with bipolar disorder
- Patients treated with lamotrigine tablets for the first time
Exclusion criteria:
- Not applicable
Trial location(s)
No location data available.
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Finalized
Actual primary completion date
Not applicable
Actual study completion date
2016-29-01
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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