An Open-Label Trial Measuring Satisfaction And Convenience Of Two Formulations Of Lamotrigine In Subjects With A Mood Disorder

Summary

To determine the convenience and satisfaction of new orally disintegrating tablet formulation (ODT) of lamictal in subjects with a mood disorder. This was a multicenter, open-label study in participants with a mood disorder, who reported difficulty or discomfort in swallowing the currently marketed IR compressed tablet formulation of lamotrigine and who had a person (such as a spouse, partner, companion, aid, nurse, caregiver, etc) willing to complete a Companion/Caregiver Question. Subjects were switched from the currently marketed lamotrigine IR formulation to a matching dose of lamotrigine IR orally disintegrating tablet (ODT) for 3 weeks to determine convenience and satisfaction.

Timeline

Start

2008-01

Primary completion

2008-02

Completion

2008-02

Publications

• Background Sajatovic M, Thompson TR, Nanry K, Edwards S, Manjunath R. Prospective, open-label trial measuring satisfaction and convenience of two formulations of lamotrigine in subjects with mood disorders. Patient Prefer Adherence. 2013 May 7;7:411-7. doi: 10.2147/PPA.S40271. Print 2013.

Drugs

Indications