Trial Outcomes & Findings for Lamotrigine for the Treatment of Mania in Youth Ages 6-17 With Bipolar Disorder (NCT NCT00181844)
NCT ID: NCT00181844
Last Updated: 2012-04-06
Results Overview
Mean reduction in YMRS score at endpoint/LOCF. This is a scale to measure symptoms of mania in children and adolescents. 11 items are rated from 0-4 (7 items) or 0-8 (4 items). The minimum (least severe) total score is 0, and maximum (most severe) total score is 60.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
51 participants
Primary outcome timeframe
baseline to 12 weeks
Results posted on
2012-04-06
Participant Flow
Participant milestones
| Measure |
Lamotrigine
|
|---|---|
|
Signed Consent
STARTED
|
51
|
|
Signed Consent
COMPLETED
|
39
|
|
Signed Consent
NOT COMPLETED
|
12
|
|
Exposed to Study Medication
STARTED
|
39
|
|
Exposed to Study Medication
COMPLETED
|
22
|
|
Exposed to Study Medication
NOT COMPLETED
|
17
|
Reasons for withdrawal
| Measure |
Lamotrigine
|
|---|---|
|
Signed Consent
Withdrawal by Subject
|
5
|
|
Signed Consent
Did not meet entrance criteria
|
7
|
|
Exposed to Study Medication
Adverse Event
|
10
|
|
Exposed to Study Medication
Lack of Efficacy
|
2
|
|
Exposed to Study Medication
Non-compliance
|
2
|
|
Exposed to Study Medication
Withdrawal by Subject
|
1
|
|
Exposed to Study Medication
Difficulty meeting study schedule
|
2
|
Baseline Characteristics
Lamotrigine for the Treatment of Mania in Youth Ages 6-17 With Bipolar Disorder
Baseline characteristics by cohort
| Measure |
Lamotrigine
n=39 Participants
|
|---|---|
|
Age, Categorical
<=18 years
|
39 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age Continuous
|
10.8 years
STANDARD_DEVIATION 2.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
39 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline to 12 weeksMean reduction in YMRS score at endpoint/LOCF. This is a scale to measure symptoms of mania in children and adolescents. 11 items are rated from 0-4 (7 items) or 0-8 (4 items). The minimum (least severe) total score is 0, and maximum (most severe) total score is 60.
Outcome measures
| Measure |
Lamotrigine
n=39 Participants
|
|---|---|
|
Change of Mania Symptoms Assessed by Young Mania Rating Scale (YMRS)
|
-14.9 Units on a scale
Standard Deviation 9.7
|
Adverse Events
Lamotrigine
Serious events: 0 serious events
Other events: 34 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Lamotrigine
n=39 participants at risk
|
|---|---|
|
Gastrointestinal disorders
Acid reflux
|
2.6%
1/39 • Number of events 5
|
|
Gastrointestinal disorders
Appetite loss
|
7.7%
3/39 • Number of events 4
|
|
General disorders
Backache
|
2.6%
1/39 • Number of events 1
|
|
General disorders
Bruising
|
2.6%
1/39 • Number of events 1
|
|
General disorders
Chest pain
|
5.1%
2/39 • Number of events 2
|
|
General disorders
Cold
|
7.7%
3/39 • Number of events 3
|
|
Gastrointestinal disorders
Constipation
|
2.6%
1/39 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
12.8%
5/39 • Number of events 9
|
|
Gastrointestinal disorders
Diarrhea
|
5.1%
2/39 • Number of events 2
|
|
Ear and labyrinth disorders
Dizziness
|
10.3%
4/39 • Number of events 5
|
|
Gastrointestinal disorders
Dyspepsia
|
7.7%
3/39 • Number of events 5
|
|
Infections and infestations
Ear infection
|
7.7%
3/39 • Number of events 3
|
|
Ear and labyrinth disorders
Ear pain
|
7.7%
3/39 • Number of events 4
|
|
Eye disorders
Eye irritation
|
5.1%
2/39 • Number of events 2
|
|
General disorders
Fatigue
|
12.8%
5/39 • Number of events 9
|
|
General disorders
Fever
|
12.8%
5/39 • Number of events 6
|
|
Gastrointestinal disorders
GERD vomiting
|
2.6%
1/39 • Number of events 2
|
|
General disorders
Headache
|
38.5%
15/39 • Number of events 37
|
|
Musculoskeletal and connective tissue disorders
Hip dysplasia
|
5.1%
2/39 • Number of events 2
|
|
General disorders
Increased appetite
|
2.6%
1/39 • Number of events 2
|
|
Injury, poisoning and procedural complications
Injury
|
28.2%
11/39 • Number of events 17
|
|
General disorders
Insomnia
|
7.7%
3/39 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Itching
|
7.7%
3/39 • Number of events 3
|
|
General disorders
Jitteriness
|
5.1%
2/39 • Number of events 2
|
|
General disorders
Lethargy
|
5.1%
2/39 • Number of events 8
|
|
General disorders
Loss of voluntary movement
|
5.1%
2/39 • Number of events 2
|
|
General disorders
Malaise
|
2.6%
1/39 • Number of events 1
|
|
Reproductive system and breast disorders
Menstrual cramps
|
2.6%
1/39 • Number of events 1
|
|
Psychiatric disorders
More manic
|
2.6%
1/39 • Number of events 1
|
|
General disorders
Nasal congestion
|
15.4%
6/39 • Number of events 7
|
|
Gastrointestinal disorders
Nausea
|
10.3%
4/39 • Number of events 10
|
|
General disorders
Nosebleed
|
2.6%
1/39 • Number of events 1
|
|
Cardiac disorders
Palpitations
|
2.6%
1/39 • Number of events 1
|
|
Psychiatric disorders
Panic attacks
|
5.1%
2/39 • Number of events 4
|
|
Injury, poisoning and procedural complications
Poison Ivy
|
2.6%
1/39 • Number of events 1
|
|
General disorders
Rhinorhea
|
10.3%
4/39 • Number of events 5
|
|
General disorders
Shakiness
|
5.1%
2/39 • Number of events 2
|
|
Infections and infestations
Sinus infection
|
2.6%
1/39 • Number of events 1
|
|
General disorders
Sore throat
|
17.9%
7/39 • Number of events 8
|
|
Gastrointestinal disorders
Stomach ache
|
17.9%
7/39 • Number of events 15
|
|
General disorders
Temper tantrum
|
5.1%
2/39 • Number of events 2
|
|
General disorders
Tooth pain
|
15.4%
6/39 • Number of events 8
|
|
General disorders
Unsteady
|
5.1%
2/39 • Number of events 2
|
|
Infections and infestations
Upper respiratory infection
|
2.6%
1/39 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
20.5%
8/39 • Number of events 13
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
2.6%
1/39 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Rashes
|
17.9%
7/39
|
|
Skin and subcutaneous tissue disorders
Contact dermatitis
|
5.1%
2/39
|
|
Skin and subcutaneous tissue disorders
Sunburn
|
5.1%
2/39
|
|
Skin and subcutaneous tissue disorders
Miscellaneous other skin lesions
|
10.3%
4/39
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place