Trial · NCT00723450
Lamictal as Add-on Treatment for Bipolar I Disorder in Pediatric Patients
NCT00723450, Phase 3, Completed, GlaxoSmithKline; results first posted 2014-06-04
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ConductScience Library. Lamictal as Add-on Treatment for Bipolar I Disorder in Pediatric Patients. Trials, record NCT00723450. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00723450
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Lamictal as Add-on Treatment for Bipolar I Disorder in Pediatric Patients
- NCT number
- NCT00723450
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 301 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Bipolar Disorder
- Interventions
- lamictal
- First posted
- 2008-07-28
- Last updated
- 2017-01-09
- Results first posted
- 2014-06-04
Source ClinicalTrials.gov
Registered outcomes22
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time From Randomization to the Occurrence of a Bipolar Event (TOBE) | From randomization until Week 36 | TOBE was defined by the first prescription of any additional pharmacotherapy to treat bipolar symptoms, increasing the dose(s) of the participants conventional bipolar medication(s), treatment with electroconvulsive therapy, or moving the participant to a more restricted environment for observation, safety, or treatment; or participant withdrawal from the study due to a bipolar-related adverse event (AE) or serious adverse event (SAE); or participants withdrawal from the study due to lack of efficacy as defined by rating scale threshold scores. TOBE was calculated using a log rank test with stratification for index mood state (depression, mania/hypomania, mixed mood). |
| Secondary | Time From Randomization to Withdrawal From the Study for Any Cause (TTW) | From randomization until withdrawal from the study for any cause (up to Week 36) | The time from randomization to the withdrawal from study was analyzed. TTW was calculated using the log rank test with stratification for index mood state (depression, mania/hypomania, mixed mood). |
| Secondary | Time From Randomization to Intervention for a Mood Episode (TIME) | From randomization until intervention administered for a mood episode (up to Week 36) | The time from randomization to the intervention for a mood episode (depression, mania/hypomania or mixed mood) was analyzed. TIME was calculated using the log rank test with stratification for index mood state (depression, mania/hypomania, mixed mood). |
| Secondary | Time From Randomization to Intervention for Depression (TIDep), Mania/Hypomania (TIMan), or a Mixed Episode (TIMix) | From randomization until intervention administered for depression, mania/hypomania or a mixed episode (up to Week 36) | The time from randomization to intervention for depression (TIDep), mania/hypomania (TIMan), or a mixed episode (TIMix) was analyzed. TIDep, TIMan, and TIMix were calculated using the log rank test with stratification for index mood state (depression, mania/hypomania, mixed mood). |
| Secondary | Number of Participants Experiencing a Relapse/Recurrence to Depression, Mania/Hypomania, or Mixed Mood State | From randomization until a relapse/recurrence to depression, mania/hypomania, or mixed mood state (up to Week 36) | The number of participants requiring intervention to treat either the emergence of or a change in bipolar symptoms that is, experiencing a relapse/recurrence to depression, mania/hypomania, or mixed mood state were analyzed. |
| Secondary | Number of Participants Experiencing a Relapse/Recurrence Within the First 30, 90, and 180 Days in the Randomized Phase | From randomization up to Week 36 | The proportion of participants (par.) requiring intervention to treat either the emergence of or a change in bipolar symptoms, that is, experiencing a relapse/recurrence to depression, mania/hypomania, or mixed mood state at any time within the first 30, 90, and 180 days in the Randomized Phase were analyzed. |
| Secondary | Change From Baseline in the Quick Inventory of Depressive Symptomatology - Clinician Interview, Semi-structured, Adolescent Version (QIDS- A17-C) at Each Visit in the Open-Label Phase | Baseline and Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, and 18 | The QIDS-A17-C is a 17-item scale used to assess depression severity in adolescents according to the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) diagnostic criteria for a major depressive episode; it is a modified version of the Quick Inventory of Depressive Symptomatology (QIDS) used for adults. Each item is scored on a 0-3 scale, yielding 9 domain scores. The range of scores is 0 (best possible outcome) to 27 (worst possible outcome). Analysis was performed using mixed model repeated measures. |
| Secondary | Change From Randomization in the Quick Inventory of Depressive Symptomatology - Clinician Interview, Semi-structured, Adolescent Version (QIDS- A17-C) at Each Visit in the Randomized Phase | Randomization and Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24, 28, 32, and 36 | The QIDS-A17-C is a 17-item scale used to assess depression severity in adolescents according to the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) diagnostic criteria for a major depressive episode; it is a modified version of the Quick Inventory of Depressive Symptomatology (QIDS) used for adults. Each item is scored on a 0-3 scale, yielding 9 domain scores. The range of scores is 0 (best possible outcome) to 27 (worst possible outcome). Analysis was performed using mixed model repeated measures. |
| Secondary | Change From Baseline in the Quick Inventory of Depressive Symptomatology - Self-report Adolescent Version (QIDS-A17-SR) at Each Visit in the Open-Label Phase | Baseline and Weeks 4, 8, 12, 16, and 18 | The QIDS-A17-SR is a 17-item scale used to assess depression severity in adolescents according to the DSM-IV-TR diagnostic criteria for a major depressive episode; it is a modified version of the Quick Inventory of Depressive Symptomatology (QIDS) used for adults. Each item is scored on a 0-3 scale, yielding 9 domain scores. The range of scores is 0 (best possible outcome) to 27 (worst possible outcome). The scale is completed by the participant. Analysis was performed using mixed model repeated measures. |
| Secondary | Change From Randomization in the Quick Inventory of Depressive Symptomatology - Self-report Adolescent Version (QIDS-A17-SR) at Each Visit in the Randomized Phase | Randomization and Weeks 8, 16, 24, 32, and 36 | The QIDS-A17-SR is a 17-item scale used to assess depression severity in adolescents according to the DSM-IV-TR diagnostic criteria for a major depressive episode; it is a modified version of the Quick Inventory of Depressive Symptomatology (QIDS) used for adults. Each item is scored on a 0-3 scale, yielding 9 domain scores. The range of scores is 0 (best possible outcome) to 27 (worst possible outcome). The scale is completed by the participant. Analysis was performed using mixed model repeated measures. |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 registered outcomesOutcomes22
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Time From Randomization to the Occurrence of a Bipolar Event (TOBE) | From randomization until Week 36 | Randomized Intent-to-Treat (ITT) Population: all participants who were randomized to LTG or placebo and received at least one dose of investigational product. | Days | MEAN |
| SECONDARY | Time From Randomization to Withdrawal From the Study for Any Cause (TTW) | From randomization until withdrawal from the study for any cause (up to Week 36) | Randomized ITT Population | Days | MEAN |
| SECONDARY | Time From Randomization to Intervention for a Mood Episode (TIME) | From randomization until intervention administered for a mood episode (up to Week 36) | Randomized ITT Population | Days | MEAN |
| SECONDARY | Time From Randomization to Intervention for Depression (TIDep), Mania/Hypomania (TIMan), or a Mixed Episode (TIMix) | From randomization until intervention administered for depression, mania/hypomania or a mixed episode (up to Week 36) | Randomized ITT Population | Days | MEAN |
| SECONDARY | Number of Participants Experiencing a Relapse/Recurrence to Depression, Mania/Hypomania, or Mixed Mood State | From randomization until a relapse/recurrence to depression, mania/hypomania, or mixed mood state (up to Week 36) | Randomized ITT Population. Only those participants requiring intervention to treat either the emergence of, or a change, in bipolar symptoms were analyzed. | Participants | NUMBER |
| SECONDARY | Number of Participants Experiencing a Relapse/Recurrence Within the First 30, 90, and 180 Days in the Randomized Phase | From randomization up to Week 36 | Randomized ITT Population. Only those participants requiring intervention to treat either the emergence of, or a change, in bipolar symptoms were analyzed. | Participants | NUMBER |
| SECONDARY | Change From Baseline in the Quick Inventory of Depressive Symptomatology - Clinician Interview, Semi-structured, Adolescent Version (QIDS- A17-C) at Each Visit in the Open-Label Phase | Baseline and Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, and 18 | Open-Label ITT population: all participants who entered the Open-Label Phase and received at least one dose of LTG. | Scores on a Scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Randomization in the Quick Inventory of Depressive Symptomatology - Clinician Interview, Semi-structured, Adolescent Version (QIDS- A17-C) at Each Visit in the Randomized Phase | Randomization and Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24, 28, 32, and 36 | Randomized ITT Population | Scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in the Quick Inventory of Depressive Symptomatology - Self-report Adolescent Version (QIDS-A17-SR) at Each Visit in the Open-Label Phase | Baseline and Weeks 4, 8, 12, 16, and 18 | Open-Label ITT Population | Scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Randomization in the Quick Inventory of Depressive Symptomatology - Self-report Adolescent Version (QIDS-A17-SR) at Each Visit in the Randomized Phase | Randomization and Weeks 8, 16, 24, 32, and 36 | Randomized ITT Population | Scores on a scale | LEAST_SQUARES_MEAN |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 outcomesResults by group335
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Time From Randomization to the Occurrence of a Bipolar Event (TOBE) | Placebo | Stratum: Depression, n=22,21 | 50 | Standard Error 3.8 | Days |
| Time From Randomization to the Occurrence of a Bipolar Event (TOBE) | Lamotrigine | Stratum: Depression, n=22,21 | 155 | Standard Error 14.7 | Days |
| Time From Randomization to the Occurrence of a Bipolar Event (TOBE) | Placebo | Stratum: Mania/Hypomania, n=36, 37 | 120 | Standard Error 12.2 | Days |
| Time From Randomization to the Occurrence of a Bipolar Event (TOBE) | Lamotrigine | Stratum: Mania/Hypomania, n=36, 37 | 163 | Standard Error 12.2 | Days |
| Time From Randomization to the Occurrence of a Bipolar Event (TOBE) | Placebo | Stratum: Mixed Mood, n=28, 29 | 107 | Standard Error 13.8 | Days |
| Time From Randomization to the Occurrence of a Bipolar Event (TOBE) | Lamotrigine | Stratum: Mixed Mood, n=28, 29 | 136 | Standard Error 15.4 | Days |
| Time From Randomization to Withdrawal From the Study for Any Cause (TTW) | Placebo | Stratum: Depression, n=22, 21 | 113 | Standard Error 21.4 | Days |
| Time From Randomization to Withdrawal From the Study for Any Cause (TTW) | Lamotrigine | Stratum: Depression, n=22, 21 | 141 | Standard Error 20.0 | Days |
| Time From Randomization to Withdrawal From the Study for Any Cause (TTW) | Placebo | Stratum: Mania/Hypomania, n=36, 37 | 138 | Standard Error 17.3 | Days |
| Time From Randomization to Withdrawal From the Study for Any Cause (TTW) | Lamotrigine | Stratum: Mania/Hypomania, n=36, 37 | 144 | Standard Error 15.6 | Days |
1 to 10 of 335Source ClinicalTrials.gov
See all 335 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Open-Label Phase | STARTED | LTG: Open-Label Phase | 298 | |
| Open-Label Phase | STARTED | Placebo | 0 | |
| Open-Label Phase | STARTED | Lamotrigine | 0 | |
| Open-Label Phase | COMPLETED | LTG: Open-Label Phase | 173 | |
| Open-Label Phase | COMPLETED | Placebo | 0 | |
| Open-Label Phase | COMPLETED | Lamotrigine | 0 | |
| Open-Label Phase | NOT COMPLETED | LTG: Open-Label Phase | 125 | |
| Open-Label Phase | NOT COMPLETED | Placebo | 0 | |
| Open-Label Phase | NOT COMPLETED | Lamotrigine | 0 | |
| Randomized Phase | STARTED | LTG: Open-Label Phase | 0 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events105
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 | Headache | Nervous system disorders | Open-Label and Open-Label Taper Phases: LTG | 106 | 298 | |
| other | Headache | Nervous system disorders | Randomized and Double-blind Taper Phases: Placebo | 18 | 86 | |
| other | Headache | Nervous system disorders | Randomized and Double-blind Taper Phases: LTG | 18 | 87 | |
| other | Dizziness | Nervous system disorders | Open-Label and Open-Label Taper Phases: LTG | 24 | 298 | |
| other | Dizziness | Nervous system disorders | Randomized and Double-blind Taper Phases: Placebo | 0 | 86 | |
| other | Dizziness | Nervous system disorders | Randomized and Double-blind Taper Phases: LTG | 0 | 87 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Open-Label and Open-Label Taper Phases: LTG | 47 | 298 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Randomized and Double-blind Taper Phases: Placebo | 3 | 86 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Randomized and Double-blind Taper Phases: LTG | 5 | 87 | |
| other | Nausea | Gastrointestinal disorders | Open-Label and Open-Label Taper Phases: LTG | 39 | 298 |
1 to 10 of 105Source ClinicalTrials.gov
See all 105 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Open-Label and Open-Label Taper Phases: LTG | ||
| Total, all-cause mortality | Randomized and Double-blind Taper Phases: Placebo | ||
| Total, all-cause mortality | Randomized and Double-blind Taper Phases: LTG | ||
| Total, other adverse events | Open-Label and Open-Label Taper Phases: LTG | 177 | 298 |
| Total, other adverse events | Randomized and Double-blind Taper Phases: Placebo | 41 | 86 |
| Total, other adverse events | Randomized and Double-blind Taper Phases: LTG | 45 | 87 |
| Total, serious adverse events | Open-Label and Open-Label Taper Phases: LTG | 19 | 298 |
| Total, serious adverse events | Randomized and Double-blind Taper Phases: Placebo | 5 | 86 |
| Total, serious adverse events | Randomized and Double-blind Taper Phases: LTG | 1 | 87 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 26598477 | DERIVED |
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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00723450
GET https://conductscience.org/api/trials/v1/NCT00723450/registered?page=2