Conditions: Mood Disorders
Keywords: Mood disorder
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 97
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: Lamictal orally disintegrating tablet (ODT)

Interventions: intervention 1: Lamotrigine
Intervention descriptions: intervention 1: Experimental formulation

Protocol document: