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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.
A Multicentre, Double-Blind, Randomised, Fixed-Dose Evaluation of the Safety and Efficacy of Lamotrigine (Lamictal®) compared to placebo as add-on therapy to lithium in the Treatment of Bipolar Depression followed by Long-term Prevention of Relapse and Recurrence of Depression and/or Mania in Subjects With Bipolar Disorder
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lamotrigine | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Score on the MADRS depression rating scale at week 8 compared to baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Scores on various mood rating scales and safety measurements at week 16 and between week 16 and week 68 compared to baseline |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials, MD | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Alkmaar | 1815 JD | Netherlands | |||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 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) | ||
| 19200421 | Background | van der Loos ML, Mulder PG, Hartong EG, Blom MB, Vergouwen AC, de Keyzer HJ, Notten PJ, Luteijn ML, Timmermans MA, Vieta E, Nolen WA; 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 Feb;70(2):223-31. doi: 10.4088/jcp.08m04152. Epub 2008 Dec 30. | |
| 20136801 |
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| Almelo |
| 7609 PP |
| Netherlands |
| GSK Investigational Site | Amersfoort | 3818 EW | Netherlands |
| GSK Investigational Site | Amsterdam | 1061 AE | Netherlands |
| GSK Investigational Site | Amsterdam | 1075 GB | Netherlands |
| GSK Investigational Site | Bennebroek | 2121 AD | Netherlands |
| GSK Investigational Site | Blaricum | 1261 AN | Netherlands |
| GSK Investigational Site | Delft | 2625 AD | Netherlands |
| GSK Investigational Site | Dordrecht | 3317 NM | Netherlands |
| GSK Investigational Site | Eindhoven | 5623 EJ | Netherlands |
| GSK Investigational Site | Enschede | 7511JX | Netherlands |
| GSK Investigational Site | Flushing | 4382 EE | Netherlands |
| GSK Investigational Site | Gouda | 2803 RT | Netherlands |
| GSK Investigational Site | Groningen | 9713 GZ | Netherlands |
| GSK Investigational Site | Hoorn | 1624 NP | Netherlands |
| GSK Investigational Site | Leiden | 2333 ZB | Netherlands |
| GSK Investigational Site | Nijmegen | 6532 SZ | Netherlands |
| GSK Investigational Site | Raalte | 8102 RR | Netherlands |
| GSK Investigational Site | Retranchement | 4525 LG | Netherlands |
| GSK Investigational Site | Rosmalen | 5248 NT | Netherlands |
| GSK Investigational Site | The Hague | 2553 RJ | Netherlands |
| GSK Investigational Site | Tilburg | 5022 GC | Netherlands |
| GSK Investigational Site | Utrecht | 3512 PG | Netherlands |
| GSK Investigational Site | Weert | 6001 BE | Netherlands |
| GSK Investigational Site | Zwolle | 8025 AB | Netherlands |
| GSK Investigational Site | Alava | 01004 | Spain |
| GSK Investigational Site | Barcelona | 08025 | Spain |
| GSK Investigational Site | Barcelona | 08035 | Spain |
| GSK Investigational Site | Barcelona | 08036 | Spain |
| GSK Investigational Site | Madrid | 28035 | Spain |
| GSK Investigational Site | Valencia | 46009 | Spain |
| Derived |
| van der Loos ML, Mulder P, Hartong EG, Blom MB, Vergouwen AC, van Noorden MS, Timmermans MA, Vieta E, Nolen WA; LamLit Study Group. Efficacy and safety of two treatment algorithms in bipolar depression consisting of a combination of lithium, lamotrigine or placebo and paroxetine. Acta Psychiatr Scand. 2010 Sep;122(3):246-54. doi: 10.1111/j.1600-0447.2009.01537.x. Epub 2010 Feb 5. |
| ID | Term |
|---|---|
| D001714 | Bipolar Disorder |
| ID | Term |
|---|---|
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000077213 | Lamotrigine |
| ID | Term |
|---|---|
| D014227 | Triazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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