Trial · NCT00579982
An Open-Label Trial Measuring Satisfaction And Convenience Of Two Formulations Of Lamotrigine In Subjects With A Mood Disorder
NCT00579982, Phase 3, Completed, GlaxoSmithKline; results first posted 2009-08-03
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. An Open-Label Trial Measuring Satisfaction And Convenience Of Two Formulations Of Lamotrigine In Subjects With A Mood Disorder. Trials, record NCT00579982. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00579982
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- An Open-Label Trial Measuring Satisfaction And Convenience Of Two Formulations Of Lamotrigine In Subjects With A Mood Disorder
- NCT number
- NCT00579982
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 97 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Mood Disorders
- Interventions
- Lamotrigine
- First posted
- 2007-12-24
- Last updated
- 2016-12-16
- Results first posted
- 2009-08-03
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| 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 | The CSS is the sum of items 9 (values: 1=Extremely difficult - 7=Extremely easy), 10 (same set of values as for 9), and 11 (1=Extremely inconvenient - 7=Extremely convenient). The sum has 3 subtracted from it, is divided by 18, and then multiplied by 100; the range is 0-100. Change from baseline=end of study CSS minus baseline score. |
| 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 | The Global Satisfaction Subscale Score is the sum of item 12 (values: 1=Not at all confident - 5=Extremely confident), item 13 (values: 1=Not at all certain - 5=Extremely certain), and item 14 (Extremely dissatisfied - 7=Extremely satisfied). The sum has 3 subtracted from it, is divided by 14, and then multiplied by 100; thus, the range is 0-100. |
| 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 | 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). |
| 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 | Participant-reported questionnaire consisting of 21 items on a 4 point scale (0 to 3, with 3 indicating most severely ill), with the score being the sum of the items. The change from baseline is the end of study score minus the baseline score; larger values indicate more depression with the ODT formulation relative to the IR formulation. |
| 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 | The Organoleptic Questionnaire (9 items) was used to assess the participants' satisfaction with the physical characteristics of the ODT formulation e.g. rate of dissolution, flavor. Question number 1 on organoleptic questionnaire: Did the tablets dissolve instantly (yes or no)? |
| 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 | Question number 2 on organoleptic questionnaire: How satisfied or dissatisfied were you with the time it took the tablet to dissolve? \[from a rating of 1 (Extremely dissatisfied) to 5 (Extremely satisfied)\] |
| 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 | Question number 3 on organoleptic questionnaire: How did the dissolved tablet feel in your mouth? \[from a rating of 1 (Extremely gritty) to 5 (Extremely smooth)\] |
| 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 | Question number 4 on organoleptic questionnaire: How satisfied were you with the flavor of the tablet? \[from a rating of 1 (Extremely dissatisfied) to 5 (Extremely satisfied)\] |
| 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 | Organoleptic Questionnaire, question 5: How would you rate the strength of the flavor of the tablet? \[from 1 a rating of (Extremely bothersome) to 5 (Extremely pleasant)\] |
| 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 | Organoleptic Questionnaire, question 6: How would you rate the aftertaste of the tablet (the taste remaining in your mouth after swallowing the tablet)? \[from a rating of 1 (Extremely bothersome) to 6 (Did NOT experience an aftertaste)\] |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 registered outcomesOutcomes16
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| 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 | Intent to Treat (ITT). Ninety-eight participants were enrolled in the study, but one withdrew prior to receiving lamotrigine ODT treatment. All efficacy and safety analyses are based on the Intent to Treat population, which includes the 97 patients who received at least one dose of ODT treatment. | Points on a subscale | MEAN |
| 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 | ITT | Points on a subscale | MEAN |
| 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 | ITT | Points on a scale | MEAN |
| 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 | ITT | Points on a scale | MEAN |
| 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 | ITT | Number of participants | NUMBER |
| 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 | ITT | Number of participants | NUMBER |
| 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 | ITT | Number of participants | NUMBER |
| 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 | ITT | Number of participants | NUMBER |
| 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 | ITT | Number of participants | NUMBER |
| 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 | ITT | Number of participants | NUMBER |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 outcomesResults by group54
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
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. | Lamotrigine | 23.3 | Standard Deviation 22.5 | Points on a subscale | |
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 | Lamotrigine | -0.3 | Standard Deviation 29.34 | Points on a subscale | |
| Mean Change From Baseline in Clinical Global Impression of Illness-Severity at Week 3 | Lamotrigine | 0.0 | Standard Deviation 0.81 | Points on a scale | |
| Mean Change From Baseline in the Beck Depression Inventory (BDI-II) Score at Week 3 | Lamotrigine | -1.7 | Standard Deviation 9.52 | Points on a scale | |
| Number of Participants Answering the Question Did the Tablets Dissolve Instantly (Yes or no)? at Week 3 | Lamotrigine | Yes | 60 | Number of participants | |
| Number of Participants Answering the Question Did the Tablets Dissolve Instantly (Yes or no)? at Week 3 | Lamotrigine | No | 37 | Number of participants | |
| Number of Participants Answering the Question How Satisfied or Dissatisfied Were You With the Time it Took the Tablet to Dissolve at Week 3 | Lamotrigine | Extremely dissatisfied | 3 | Number of participants | |
| Number of Participants Answering the Question How Satisfied or Dissatisfied Were You With the Time it Took the Tablet to Dissolve at Week 3 | Lamotrigine | Very dissatisfied | 10 | Number of participants | |
| Number of Participants Answering the Question How Satisfied or Dissatisfied Were You With the Time it Took the Tablet to Dissolve at Week 3 | Lamotrigine | Satisfied | 37 | Number of participants | |
| Number of Participants Answering the Question How Satisfied or Dissatisfied Were You With the Time it Took the Tablet to Dissolve at Week 3 | Lamotrigine | Very satisfied | 18 | Number of participants |
1 to 10 of 54Source ClinicalTrials.gov
See all 54 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Lamotrigine | 97 | |
| Overall Study | COMPLETED | Lamotrigine | 89 | |
| Overall Study | NOT COMPLETED | Lamotrigine | 8 |
Source ClinicalTrials.gov
Adverse events32
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anxiety | Psychiatric disorders | Lamotrigine | 3 | 97 | |
| other | Depression | Psychiatric disorders | Lamotrigine | 3 | 97 | |
| other | Hypomania | Psychiatric disorders | Lamotrigine | 3 | 97 | |
| other | Depressed mood | Psychiatric disorders | Lamotrigine | 1 | 97 | |
| other | Insomnia | Psychiatric disorders | Lamotrigine | 1 | 97 | |
| other | Restlessness | Psychiatric disorders | Lamotrigine | 1 | 97 | |
| other | Suicidal ideation | Psychiatric disorders | Lamotrigine | 1 | 97 | |
| other | Headache | Nervous system disorders | Lamotrigine | 5 | 97 | |
| other | Dizziness | Nervous system disorders | Lamotrigine | 1 | 97 | |
| other | Nausea | Gastrointestinal disorders | Lamotrigine | 2 | 97 |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Lamotrigine | ||
| Total, other adverse events | Lamotrigine | 28 | 97 |
| Total, serious adverse events | Lamotrigine | 1 | 97 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 23687443 | BACKGROUND |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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