Last updated: 11/07/2018 18:59:39
A Multicenter, Double–Blind, Placebo–Controlled, Fixed Dose (50 or 200mg per day) 7 Week Evaluation of the Safety and Efficacy of LAMICTAL (Lamotrigine) in the Treatment of a Major Depressive Episode in Patients Suffering From Bipolar Disorder
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, Fixed Dose (50 or 200mg per day) 7 Week Evaluation of the Safety and Efficacy of LAMICTAL (Lamotrigine) in the Treatment of a Major Depressive Episode in Patients Suffering From Bipolar Disorder
Trial description: A Multicenter, Double–Blind, Placebo–Controlled, Fixed Dose (50 or 200mg per day) 7 Week Evaluation of the Safety and Efficacy of LAMICTAL (Lamotrigine) in the Treatment of a Major Depressive Episode in Patients Suffering From 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:
Calabrese JR, Bowden CL, Sach GS, et. al. A double-blind placebo-controlled study of lamotrigine monotherapy in outpatients with bipolar I depression. J Clin Psychiatry 1999;60(2):79-88.
Medical condition
Depressive Disorder, Major
Product
lamotrigine
Collaborators
Not applicable
Study date(s)
April 1996 to November 1997
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
1997-14-11
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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