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

Study Type:	Interventional
Study Design:	Non-Randomized, Open Label, Single Group Assignment
Condition:	Mood Disorder
Intervention:	Drug: Lamotrigine

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

	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

Outcome Measures

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 ]

Show Outcome Measure 1

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 ]

Show Outcome Measure 2

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 ]

Hide Outcome Measure 3

Measure Type	Secondary
Measure Title	Mean Change From Baseline in Clinical Global Impression of Illness-Severity at Week 3
Measure Description	Clinician assessment evaluating how mentally ill the patient is at time of evaluation. The questionnaire is based on a 7-point scale (from1 = Normal to 7 = Among the most extremely ill patients).
Time Frame	Baseline, End of Study (Week 3) or at Early Withdrawal
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT

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.

Measured Values

	Lamotrigine
Number of Participants Analyzed [units: participants]	96
Mean Change From Baseline in Clinical Global Impression of Illness-Severity at Week 3 [units: Points on a scale] Mean ± Standard Deviation	0.0 ± 0.81

No statistical analysis provided for Mean Change From Baseline in Clinical Global Impression of Illness-Severity at Week 3

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 ]

Show Outcome Measure 4

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 ]

Show Outcome Measure 5

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 ]

Show Outcome Measure 6

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 ]

Show Outcome Measure 7

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 ]

Show Outcome Measure 8

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 ]

Show Outcome Measure 9

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 ]

Show Outcome Measure 10

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 ]

Show Outcome Measure 11

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 ]

Show Outcome Measure 12

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 ]

Show Outcome Measure 13

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 ]

Show Outcome Measure 14

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 ]

Show Outcome Measure 15

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 ]

Show Outcome Measure 16

More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact:

Name/Title: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343

No publications provided

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	LBI108884
Study First Received:	December 20, 2007
Results First Received:	June 4, 2009
Last Updated:	September 16, 2009
ClinicalTrials.gov Identifier:	NCT00579982 History of Changes
Health Authority:	United States: Food and Drug Administration