Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00723450 | Lamictal as Add-on Treatment for Bipolar I Disorder in Pediatric Patients | PHASE3 | COMPLETED | 301 | — | — | Jul 1, 2008 | Aug 1, 2013 | Jan 9, 2017 | 46 | United States |
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).
| Arm | Type | Description |
|---|---|---|
| placebo | PLACEBO_COMPARATOR | Placebo Controlled |
| lamictal | EXPERIMENTAL | Flexible Dosing |
| Name | Type | Description |
|---|---|---|
| lamictal | DRUG | Flexible Dosing |
Inclusion Criteria * Subject is male or female between the ages of 10 and 17 years, inclusive. * Subject has a diagnosis of bipolar I disorder and is currently experiencing a manic/hypomanic, depressed, or mixed mood episode * Subject is currently receiving a stable treatment regimen. * Subject is ...