Last updated: 11/07/2018 18:58:54
A Multicenter, Double-Blind, Placebo-Controlled, Flexible-Dose, Parallel-Group Evaluation of the Safety and Efficacy of Lamotrigine in the Long-Term Prevention of Mood Episodes in Patients with Bipolar Disorder with Rapid Cycling
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A Multicenter, Double-Blind, Placebo-Controlled, Flexible-Dose, Parallel-Group Evaluation of the Safety and Efficacy of Lamotrigine in the Long-Term Prevention of Mood Episodes in Patients with Bipolar Disorder with Rapid Cycling
Trial description: A Multicenter, Double-Blind, Placebo-Controlled, Flexible-Dose, Parallel-Group Evaluation of the Safety and Efficacy of Lamotrigine in the Long-Term Prevention of Mood Episodes in Patients with Bipolar Disorder with Rapid Cycling
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:
Calabrese JR, Suppes T, Bowden CL, et al. A dougle-blind, placebo-controlled, prophylaxis study of lamotrigine in rapid-cycling bipolar disorder. J Clin Psychiatry. 2000;61:841-50.
Medical condition
Bipolar Disorder
Product
lamotrigine
Collaborators
Not applicable
Study date(s)
September 1997 to October 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
1999-08-10
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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