Trial Outcomes & Findings for Invega (Paliperidone) for the Treatment of Mania in Children and Adolescents Ages 6-17 With Bipolar Disorder (NCT NCT00592358)
NCT ID: NCT00592358
Last Updated: 2012-07-04
Results Overview
The YMRS is an 11-item instrument used to assess the severity of mania in patients with a diagnosis of bipolar disorder. Four items are graded on a 0 to 8 scale (irritability, speech, thought content, and disruptive/aggressive behavior), while the remaining seven itemsare graded on a 0 to 4 scale. The maximum possible total score is 60 (worse outcome, severe symptoms), and the minimum possible total score is 0 (no symptoms).
TERMINATED
PHASE4
17 participants
Baseline and 8 weeks (or final study visit, if subjects completed the study before 8 weeks)
2012-07-04
Participant Flow
Participant milestones
| Measure |
Paliperidone
Open label treatment with Invega (Paliperidone) once daily, with dosage of 3mg per day, titrated in 3mg increments to a maximum of 6mg per day based on subject age, weight and tolerance.
|
|---|---|
|
Overall Study
STARTED
|
17
|
|
Overall Study
COMPLETED
|
11
|
|
Overall Study
NOT COMPLETED
|
6
|
Reasons for withdrawal
| Measure |
Paliperidone
Open label treatment with Invega (Paliperidone) once daily, with dosage of 3mg per day, titrated in 3mg increments to a maximum of 6mg per day based on subject age, weight and tolerance.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Lack of Efficacy
|
2
|
|
Overall Study
Inability to swallow pills
|
1
|
Baseline Characteristics
Invega (Paliperidone) for the Treatment of Mania in Children and Adolescents Ages 6-17 With Bipolar Disorder
Baseline characteristics by cohort
| Measure |
Paliperidone
n=17 Participants
Open label treatment with Invega (Paliperidone) once daily, with dosage of 3mg per day, titrated in 3mg increments to a maximum of 6mg per day based on subject age, weight and tolerance.
|
|---|---|
|
Age, Categorical
<=18 years
|
17 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
|
Age Continuous
|
9.88 years
STANDARD_DEVIATION 2.39 • n=93 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
17 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Baseline and 8 weeks (or final study visit, if subjects completed the study before 8 weeks)Population: Participants exposed to study medication for a minimum of three weeks were included in analyses.
The YMRS is an 11-item instrument used to assess the severity of mania in patients with a diagnosis of bipolar disorder. Four items are graded on a 0 to 8 scale (irritability, speech, thought content, and disruptive/aggressive behavior), while the remaining seven itemsare graded on a 0 to 4 scale. The maximum possible total score is 60 (worse outcome, severe symptoms), and the minimum possible total score is 0 (no symptoms).
Outcome measures
| Measure |
Paliperidone
n=15 Participants
Open-label treatment with Paliperidone.
|
|---|---|
|
Change in Symptoms Measured by Young Mania Rating Scale (YMRS)
Baseline
|
32.8 units on a scale
Standard Deviation 6.1
|
|
Change in Symptoms Measured by Young Mania Rating Scale (YMRS)
Endpoint
|
14.1 units on a scale
Standard Deviation 11.2
|
SECONDARY outcome
Timeframe: Baseline and 8 weeks (or final study visit, if subjects completed the study before 8 weeks)Population: All participants for whom the mania checklist was available at both baseline and endpoint (8-weeks) were included in analyses.
A 13-item clinician-rated symptom checklist developed by Massachusetts General Hospital to measure symptoms of mania. Each item is given a rating for frequency (1=less than 4 days, 2=greater than or equal to 4 days, 3=daily) and intensity (1=mild, 2=moderate, 3=severe), which are combined to yield a composite severity score ranging from 0 (least severe) to 3 (most severe). The composite severity scores from all 13 items are summed to yield a total measure score, with a minimum score of 0 (least severe) and a maximum score of 39 (most severe).
Outcome measures
| Measure |
Paliperidone
n=8 Participants
Open-label treatment with Paliperidone.
|
|---|---|
|
Change in Symptoms Measured by DSM-IV Mania Symptoms Checklist
Baseline
|
18.5 units on a scale
Standard Deviation 5.6
|
|
Change in Symptoms Measured by DSM-IV Mania Symptoms Checklist
Endpoint
|
10.9 units on a scale
Standard Deviation 6.3
|
Adverse Events
Paliperidone
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Paliperidone
n=15 participants at risk
Open label treatment with Invega (Paliperidone) once daily, with dosage of 3mg per day, titrated in 3mg increments to a maximum of 6mg per day based on subject age, weight and tolerance.
|
|---|---|
|
Skin and subcutaneous tissue disorders
Plaque-like skin lesion
|
6.7%
1/15 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Superficial scratches on arm
|
6.7%
1/15 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Acne
|
6.7%
1/15 • Number of events 1
|
|
Eye disorders
Blurred vision
|
20.0%
3/15 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
6.7%
1/15 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cold symptoms
|
26.7%
4/15 • Number of events 6
|
|
Gastrointestinal disorders
Diarrhea
|
6.7%
1/15 • Number of events 1
|
|
Renal and urinary disorders
Enuresis
|
6.7%
1/15 • Number of events 1
|
|
General disorders
Mild extrapyrimidal symptoms
|
6.7%
1/15 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Erythema
|
6.7%
1/15 • Number of events 2
|
|
Eye disorders
Eye twitching
|
6.7%
1/15 • Number of events 2
|
|
General disorders
Flu like symptoms
|
20.0%
3/15 • Number of events 3
|
|
General disorders
Headache
|
20.0%
3/15 • Number of events 7
|
|
Metabolism and nutrition disorders
Increased appetite
|
40.0%
6/15 • Number of events 15
|
|
General disorders
insomnia
|
33.3%
5/15 • Number of events 6
|
|
Gastrointestinal disorders
Nausea
|
6.7%
1/15 • Number of events 3
|
|
Cardiac disorders
Heart palpitation
|
6.7%
1/15 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash
|
13.3%
2/15 • Number of events 6
|
|
Respiratory, thoracic and mediastinal disorders
Seasonal allergies
|
6.7%
1/15 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
20.0%
3/15 • Number of events 3
|
|
General disorders
Strep throat
|
13.3%
2/15 • Number of events 4
|
|
Gastrointestinal disorders
Vomiting
|
13.3%
2/15 • Number of events 2
|
|
Metabolism and nutrition disorders
Weight gain
|
6.7%
1/15 • Number of events 1
|
|
Psychiatric disorders
Worsening of anxiety and depressive symptoms
|
6.7%
1/15 • Number of events 1
|
|
Metabolism and nutrition disorders
Low appetite
|
13.3%
2/15 • Number of events 3
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place