Prospective, open-label trial measuring satisfaction and convenience of two formulations of lamotrigine in subjects with mood disorders
Martha Sajatovic,1 Thomas R Thompson,2 Kevin Nanry,3 Suzanne Edwards,2 Ranjani Manjunath2
1Case Western Reserve University School of Medicine and University Hospitals of Cleveland, Cleveland, OH, 2GlaxoSmithKline, Research Triangle Park, NC; 3Quintiles, Durham, NC, USA
Background: Lamotrigine is an anticonvulsant drug indicated for the maintenance treatment of bipolar I disorder and for various types of epilepsy. An orally disintegrating tablet (ODT) of lamotrigine was developed to provide a formulation option that might increase patient convenience and satisfaction.
Methods: Subjects with mood disorders who reported difficulty swallowing currently prescribed lamotrigine immediate-release medication (baseline) were enrolled and treated with lamotrigine ODT for three weeks (end of treatment). Subject satisfaction and convenience were measured using the Treatment Satisfaction Questionnaire for Medication (TSQM). Also measured were global psychopathology using the Clinical Global Impression severity index (CGI-S) and depressive symptoms using the Beck Depression Inventory (BDI-II).
Results: Lamotrigine ODT was found to be significantly more convenient to use than lamotrigine immediate-release (change in baseline TSQM convenience score: 23.3, n = 97, P < 0.001). The mean TSQM global satisfaction score was similar at baseline (76.3) and after treatment with lamotrigine ODT (76.0). There were no significant changes on CGI-S and BDI-II.
Conclusion: Subjects reported that lamotrigine ODT was significantly more convenient than lamotrigine immediate-release, while both formulations were associated with good satisfaction. Lamotrigine ODT may be a treatment option for patients who have difficulty swallowing medication.
Keywords: lamotrigine, epilepsy, antiepileptic drug, bipolar disorder, mood disorder