Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups

	Description
Lamotrigine	Orally Disintegrating Tablet (ODT). ODT dosing was to match the dose and regimen of the immediate release (IR) dose the subject was taking at baseline. The mean (standard deviation [SD]) ODT dose was 261.3 (118.9) mg/day.

Participant Flow:   Overall Study

	Lamotrigine
STARTED	97
COMPLETED	89
NOT COMPLETED	8
Adverse Event	4
Protocol Violation	4

Reporting Groups

	Description
Lamotrigine	Orally Disintegrating Tablet (ODT). ODT dosing was to match the dose and regimen of the immediate release (IR) dose the subject was taking at baseline. The mean (standard deviation [SD]) ODT dose was 261.3 (118.9) mg/day.

Baseline Measures

	Lamotrigine
Number of Participants   [units: participants]	97
Age   [units: years] Mean ± Standard Deviation	41.0 ± 12.07
Gender   [units: participants]
Female	83
Male	14
Race/Ethnicity, Customized   [units: participants]
White	94
Black	2
Mixed race	1

1.  Primary:

Mean Change From Baseline in the Convenience Subscale Score (CSS) Derived From the Treatment Satisfaction Questionnaire for Medication (TSQM v 1.4) Using Items 9 (Ease of Use), 10 (Ease of Planning to Use), and 11 (Convenience) at Week 3.   [ Baseline, End of Study (Week 3) or Early Withdrawal ]

2.  Secondary:

Mean Change From Baseline in the Global Satisfaction Subscale Score, From the TSQM Using Items 12 (Confidence in Medicine), 13 (Certainty That Good Things About Medication Outweigh Bad Things), and 14 (Satisfaction With Medication) at Week 3   [ Baseline, End of Study (Week 3) or Early Withdrawal ]

3.  Secondary:

Mean Change From Baseline in Clinical Global Impression of Illness-Severity at Week 3   [ Baseline, End of Study (Week 3) or at Early Withdrawal ]

4.  Secondary:

Mean Change From Baseline in the Beck Depression Inventory (BDI-II) Score at Week 3   [ Baseline, End of Study (Week 3 weeks) or at Early Withdrawal ]

5.  Secondary:

Number of Participants Answering the Question "Did the Tablets Dissolve Instantly (Yes or no)?" at Week 3   [ End of Study (Week 3) or Early Withdrawal ]

6.  Secondary:

Number of Participants Answering the Question "How Satisfied or Dissatisfied Were You With the Time it Took the Tablet to Dissolve" at Week 3   [ Baseline, End of Study (Week 3) or Early Withdrawal ]

7.  Secondary:

Number of Participants Answering the Question “How Did the Dissolved Tablet Feel in Your Mouth?” at Week 3   [ End of Study (Week 3) or Early Withdrawal ]

8.  Secondary:

Number of Participants Answering the Question "How Satisfied Were You With the Flavor of the Tablet?" at Week 3   [ End of Study (Week 3) or Early Withdrawal ]

9.  Secondary:

Number of Participants Answering the Question "How Would You Rate the Strength of the Flavor of the Tablet"? at Week 3   [ End of Study (Week 3) or Early Withdrawal ]

10.  Secondary:

Number of Participants Answering the Question "How Would You Rate the Aftertaste of the Tablet"? at Week 3.   [ End of Study (Week 3) or Early Withdrawal ]

11.  Secondary:

Number of Participants Answering the Question "How Satisfied Were You With the Aftertaste of the Tablet"? at Week 3   [ Baseline, End of Study (Week 3) or Early Withdrawal ]

12.  Secondary:

Number of Participants Answering the Question "Compared to Standard Tablets That Need to be Swallowed With Liquid, How Convenient or Inconvenient Did You Find This Orally Disintegrating Tablet"? at Week 3   [ End of Study (Week 3) or at Early Withdrawal ]

13.  Secondary:

Number of Participants Answering the Question "Compared to Standard Tablets That Need to be Swallowed With Liquid, How Easy or Difficult is it to Use This Orally Disintegrating Tablet?" at Week 3   [ End of Study (Week 3) or at Early Withdrawal ]

14.  Secondary:

Number of Participants Indicating a Preference for ODT or the Standard IR Tablet at Week 3   [ End of Study (Week 3) or at Early Withdrawal ]

15.  Secondary:

Number of Companions/Caregivers Indicating Whether ODT or Standard IR Tablet is More Convenient at Week 3   [ End of Study (Week 3) or at Early Withdrawal ]

16.  Secondary:

Number of Participants Indicating at Week 3 (by Answering Yes/no) That They Would be More Likely to Take the ODT Formulation   [ End of Study (Week 3) or at Early Withdrawal ]