Phase 3
N=298
Lamictal as Add-on Treatment for Bipolar I Disorder in Pediatric Patients
Bipolar Disorder
Bottom Line
View on ClinicalTrials.gov: NCT00723450 ↗Enrolled (actual)
298
Serious AEs
5.3%
Results posted
Jun 2014
Primary outcome: Primary: Time From Randomization to the Occurrence of a Bipolar Event (TOBE) — 50; 155; 120; 163 Days — p=0.0717
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- lamictal (Drug)
- Age
- Pediatric · 10+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Aug 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time From Randomization to the Occurrence of a Bipolar Event (TOBE) |
50; 155; 120; 163; 107; 136 | 0.0717 |
| SECONDARY Time From Randomization to Withdrawal From the Study for Any Cause (TTW) |
113; 141; 138; 144; 101; 106 | — |
| SECONDARY Time From Randomization to Intervention for a Mood Episode (TIME) |
62; 164; 129; 179; 120; 127 | — |
| SECONDARY Time From Randomization to Intervention for Depression (TIDep), Mania/Hypomania (TIMan), or a Mixed Episode (TIMix) |
61; 46; NA; NA; 59; 159 | — |
| SECONDARY Number of Participants Experiencing a Relapse/Recurrence to Depression, Mania/Hypomania, or Mixed Mood State |
5; 3; 16; 6; 10; 9 | — |
| SECONDARY Number of Participants Experiencing a Relapse/Recurrence Within the First 30, 90, and 180 Days in the Randomized Phase |
9; 2; 12; 4; 16; 5 | — |
| 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 |
-2.1; -2.9; -3.7; -3.8; -4.3; -4.7 | — |
| 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 |
0.8; 0.5; 1.5; 1.1; 1.3; 0.6 | — |
| 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 |
-2.7; -3.3; -4.3; -4.5; -5.0 | — |
| 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 |
1.6; 1.2; 1.6; 1.4; 1.0; 1.5 | — |
| SECONDARY Change From Baseline in the Clinical Global Impressions - Bipolar, Severity of Illness (CGI-BP[S]) at Each Visit in the Open-Label Phase |
-0.4; -0.6; -0.9; -1.0; -1.2; -1.3 | — |
| SECONDARY Change From Randomization in the Clinical Global Impressions - Bipolar, Severity of Illness (CGI-BP[S]) at Each Visit in the Randomized Phase |
0.2; 0.0; 0.4; 0.2; 0.4; 0.2 | — |
| SECONDARY Summary of Clinical Global Impressions - Bipolar - Improvement of Illness (CGI-BP [I]) Scores During Open-label Phase |
3.6; 3.3; 3.1; 3.0; 2.8; 2.7 | — |
| SECONDARY Summary of Clinical Global Impressions - Bipolar - Improvement of Illness (CGI-BP [I]) Scores During Randomized Phase |
3.3; 3.3; 3.7; 3.6; 3.6; 3.6 | — |
| SECONDARY Number of Participants Considered Much Improved or Very Much Improved [Defined as a Clinical Global Impression-Bipolar Version, Improvement of Illness (CGI-BP[I]), Score of 1 or 2] at Each Visit Compared to Baseline in the Open-Label Phase |
27; 46; 72; 86; 113; 124 | — |
| SECONDARY Number of Participants Considered Much Improved or Very Much Improved [Defined as a Clinical Global Impression-Bipolar Version, Improvement of Illness (CGI-BP[I]), Score of 1 or 2] at Each Visit Compared to Randomization in the Randomized Phase |
31; 31; 25; 22; 24; 21 | — |
| SECONDARY Change From Baseline in the Young Mania Rating Scale (YMRS) at Each Visit in the Open-Label Phase |
-3.2; -4.8; -6.4; -6.5; -7.5; -8.4 | — |
| SECONDARY Change From Randomization in the Young Mania Rating Scale (YMRS) at Each Visit in the Randomized Phase |
1.3; 0.4; 2.6; 2.1; 2.6; 1.3 | — |
| SECONDARY Change From Baseline in the Parent Version of the Young Mania Rating Scale (P-YMRS) at Each Visit in the Open-Label Phase |
-4.7; -6.0; -7.4; -8.2; -9.3 | — |
| SECONDARY Change From Randomization in the Parent Version of the Young Mania Rating Scale (P-YMRS) at Each Visit in the Randomized Phase |
4.9; 4.3; 2.7; 2.6; 5.3; 5.7 | — |
| SECONDARY Change From Baseline in the Conners' Global Index - Parent Version (CGI-P) at Each Visit in the Open-Label Phase |
-4.0; -5.7; -6.7; -7.1; -8.2 | — |
| SECONDARY Change From Randomization in the Conners' Global Index - Parent Version (CGI-P) at Each Visit in the Randomized Phase. |
3.1; 2.1; 3.4; 1.2; 2.4; 3.1 | — |
Summary
The study will be a multi-center, parallel, group, placebo control, double-blind, randomized controlled trial of lamictal as add-on maintenance treatment in pediatric outpatients (aged 10 to 17 years) diagnosed with Bipolar I disorder. The study consists of 4 phases: Screen (approximately 2 weeks), Open label phase (up to 18 weeks), Randomized phase (up to 36 weeks) and Taper and follow-up phase (up to 4 weeks).
Eligibility Criteria
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 living with his/her custodial parent(s) or legal guardian(s) and has contact with them on a daily basis.
Exclusion Criteria
- Subject has been diagnosed with a primary Axis I disorder (with the exception of bipolar I disorder, ADHD, anxiety disorders, oppositional defiant disorder, or conduct disorder) or any Axis II disorder.
- Subject currently has signs or symptoms of psychosis or a history of psychosis within the previous four weeks.
- Subject has been diagnosed with epilepsy, autism, Asperger's syndrome, or Tourette's syndrome.
- Subject has experienced a serious rash, such as Stevens-Johnson Syndrome or Toxic Epidermal Necrolysis, or a rash otherwise requiring hospitalization.
- Subject has experienced a rash related to prior LAMICTAL use, or for whom LAMICTAL treatment was discontinued for clinically significant safety reasons.
- Subject has received any antidepressant medication, or atomoxetine, during the four weeks prior to the Screen Visit.
- Subject has initiated psychotherapy within 2 months prior to the Screen Visit, or plans to initiate psychotherapy during the trial.
- Subject in the 10-12 year old age group has a Body Mass Index (BMI) less than or equal 15 or greater than or equal to 30; a subject in the 13-17 year old age group has a BMI less than or equal to 17 or greater than or equal to 34.
- Subject tests positive for illicit drug use at the Screen Visit, has a history of alcohol or substance abuse or dependence (other than nicotine dependence) within the past three months, or has a positive blood alcohol level at the Screen Visit.
- Subject, in the investigator's judgment, poses a current homicidal or serious suicidal risk, has made a suicide attempt within the twelve months preceding the Screen Visit, has ever been homicidal.
Data sourced from ClinicalTrials.gov (NCT00723450). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.