Last updated: 11/04/2018 11:35:25
A Study To Investigate The Antidepressant Effect Of Lamotrigine In Patients With Bipolar Disorder Using Lithium
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A mulitcentre, double-blind, randomised, fixed-dose evaluation of the safety and efficacy of Lamictal (lamotrigine) compared to placebo as an add-on therapy to lithium or another mood stabiliser in the treatment of bipolar depression, followed by long-term prevention of relapse and recurrence of depression and/or mania in patients with bipolar disorder
Trial description: This is a study that, in the first 16 weeks, investigates whether lamotrigine versus placebo offers effect on depressive episodes for patients with bipolar disorder (also known as manic depressive disorder) who use lithium. In the following 50 weeks it is investigated whether these patients experience effect on their depressive and/ or (hypo)manic episodes.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Drug: lamotrigine
Enrollment:
120
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Poster presented at the APA congress, US, 2007 (Lamotrigine as add-on to lithium in bipolar depression) and the 5th European Stanley Conference on Bipolar Disorder in Barcelona, 2006)
van der Loos ML, Mulder PG, Hartong EG, Blom MB, Vergouwen AC, et al; LamLit Study Group. Efficacy and safety of lamotrigine as add-on treatment to lithium in bipolar depression: a multicenter, double-blind, placebo-controlled trial. J Clin Psychiatry. 2009;70(2):223-31
Medical condition
Bipolar Disorder
Product
lamotrigine, paroxetine
Collaborators
Not applicable
Study date(s)
August 2002 to September 2006
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- Patients with bipolar disorder (type I or type II) currently suffering from depression that is at least moderate in severity according to a psychiatrist.
- Currently using lithium.
- Actively suicidal.
- Rapid cyclers.
Inclusion and exclusion criteria
Inclusion criteria:
- Patients with bipolar disorder (type I or type II) currently suffering from depression that is at least moderate in severity according to a psychiatrist.
- Currently using lithium.
- Female subjects can't be pregnant or become pregnant during the study.
Exclusion criteria:
- Actively suicidal.
- Rapid cyclers.
- Suffering from significant personality disorders.
- Alcohol or substance dependent or abusive.
- Suffering from significant physical conditions.
Trial location(s)
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
Completed
Actual primary completion date
Not applicable
Actual study completion date
2006-12-09
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
Additional information
Not applicable
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