Last updated: 11/07/2018 19:00:46
A Six-Week, Multicenter, Double-Blind, Placebo-Controlled, Fixed-Dose Evaluation of the Safety and Efficacy of Lamotrigine Compared to Placebo and Lithium in the Treatment of an Acute Manic Episode in Patients who have Bipolar Disorder
Clinicaltrials.gov ID
Not applicable
EudraCT ID
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EU CT Number
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Trial status
Study complete
Study complete
Trial overview
Official title: A Six-Week, Multicenter, Double-Blind, Placebo-Controlled, Fixed-Dose Evaluation of the Safety and Efficacy of Lamotrigine Compared to Placebo and Lithium in the Treatment of an Acute Manic Episode in Patients who have Bipolar Disorder
Trial description: A Six-Week, Multicenter, Double-Blind, Placebo-Controlled, Fixed-Dose Evaluation of the Safety and Efficacy of Lamotrigine Compared to Placebo and Lithium in the Treatment of an Acute Manic Episode in Patients who have Bipolar Disorder
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Not applicable
Enrollment:
Not applicable
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Bowden CL, Calabrese JR, Ascher J, et. al. Spectrum of efficacy of lamotrigine in bipolar disorder: Overview of double-blind, placebo-controlled studies. 39th ACNP Annual Meeting, December 10-14, 2000, San juan , Puerto Rico.
Goldsmith DR, Wagstaff AJ, Ibbotson T, Perry CM. Lamotrigine: A Review of its Use in Bipolar Disorder. Drugs 2003; 63(19):2029-2050.
Medical condition
Bipolar Disorder
Product
lamotrigine
Collaborators
Not applicable
Study date(s)
January 1998 to March 1999
Type
Not applicable
Phase
3
Participation criteria
Sex
Not applicable
Age
Not applicable
Accepts healthy volunteers
Not applicable
Inclusion and exclusion criteria
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Not applicable
Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
1999-10-03
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Not applicable
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