Trial Outcomes & Findings for Pediatric Bipolar Depression (NCT NCT00811473)
NCT ID: NCT00811473
Last Updated: 2014-07-15
Results Overview
Severity of depression in children and adolescents was calculated based on the 17-item CDRS-R scale (3 items scored from 1-5 and 14 items scored from 1-7, with higher scores indicating more severe depression). The 17 item scores are summed to give the total score (total score range 17-113).
COMPLETED
PHASE3
193 participants
Will be scored at all visits. the analysis is the change from baseline to the final assessment at day 57
2014-07-15
Participant Flow
This multicenter study was conducted between 27 January 2009 and 1 November 2010, which included the recall visit. The recall visit occurred from 5 June 2010 till 1 November 2010.
The study had an up to 35-day enrollment period, 8-week double-blind treatment period with 1 of 2 treatment regimens (quetiapine XR 150 to 300 mg/day or placebo), 1-week safety follow-up period, 2- to 4-week safety follow-up period for patients with BP \>95th percentile at completion/discontinuation.
Participant milestones
| Measure |
Quetiapine XR
Quetiapine XR 150 to 300mg once a day
|
Placebo
Matching placebo
|
|---|---|---|
|
Overall Study
STARTED
|
93
|
100
|
|
Overall Study
COMPLETED
|
70
|
74
|
|
Overall Study
NOT COMPLETED
|
23
|
26
|
Reasons for withdrawal
| Measure |
Quetiapine XR
Quetiapine XR 150 to 300mg once a day
|
Placebo
Matching placebo
|
|---|---|---|
|
Overall Study
Adverse Event
|
3
|
12
|
|
Overall Study
Lost to Follow-up
|
5
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
4
|
|
Overall Study
Severe non-compliance to protocol
|
2
|
4
|
|
Overall Study
Lack of therapeutic response
|
4
|
1
|
|
Overall Study
Condition under investigation worsened
|
1
|
3
|
|
Overall Study
Other 2
|
4
|
1
|
|
Overall Study
Incorrect Enrollment
|
1
|
0
|
|
Overall Study
Safety Reasons
|
1
|
0
|
Baseline Characteristics
Pediatric Bipolar Depression
Baseline characteristics by cohort
| Measure |
Quetiapine XR
n=92 Participants
Quetiapine XR 150 to 300mg once a day
|
Placebo
n=100 Participants
Matching placebo
|
Total
n=192 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
13.9 years
STANDARD_DEVIATION 2.18 • n=5 Participants
|
14.0 years
STANDARD_DEVIATION 2.05 • n=7 Participants
|
14.0 years
STANDARD_DEVIATION 2.11 • n=5 Participants
|
|
Sex: Female, Male
Female
|
47 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
95 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
45 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
97 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Will be scored at all visits. the analysis is the change from baseline to the final assessment at day 57Severity of depression in children and adolescents was calculated based on the 17-item CDRS-R scale (3 items scored from 1-5 and 14 items scored from 1-7, with higher scores indicating more severe depression). The 17 item scores are summed to give the total score (total score range 17-113).
Outcome measures
| Measure |
Quetiapine XR
n=92 Participants
Quetiapine XR 150 to 300mg once a day
|
Placebo
n=100 Participants
Matching placebo
|
|---|---|---|
|
Change in the Children Depression Rating Scale, Revised (CDRS-R) Total Score From Baseline to Final Assessment (Day 57)
|
-29.6 Scores on a scale
Standard Error 1.65
|
-27.3 Scores on a scale
Standard Error 1.60
|
SECONDARY outcome
Timeframe: Days 8 to 57The number of patients with remission from Days 8 to 57 was calculated. The CDRS-R is a 17-item scale with 3 items scored from 1-5 and 14 items scored from 1-7, where higher scores indicating more severe depression. The 17 item scores are summed to give the total score (total score range 17-113).
Outcome measures
| Measure |
Quetiapine XR
n=92 Participants
Quetiapine XR 150 to 300mg once a day
|
Placebo
n=100 Participants
Matching placebo
|
|---|---|---|
|
Number of Patients Reaching Remission Where Remission is Defined as CDRS-R Total Score ≤28 at Final Assessment (Day 57).
|
42 participants
|
34 participants
|
SECONDARY outcome
Timeframe: Days 8 to 57The number of patients reaching response from Days 8 to 57 was calculated. The CDRS-R is a 17-item scale with 3 items scored from 1-5 and 14 items scored from 1-7, where higher scores indicating more severe depression. The 17 item scores are summed to give the total score (total score range 17-113).
Outcome measures
| Measure |
Quetiapine XR
n=92 Participants
Quetiapine XR 150 to 300mg once a day
|
Placebo
n=100 Participants
Matching placebo
|
|---|---|---|
|
The Number of Patients With the Response, Where Response is Defined as ≥50% Reduction From Baseline to Final Assessment (Day 57) in CDRS-R Total Score
|
58 participants
|
55 participants
|
SECONDARY outcome
Timeframe: Change from Baseline to Day 57The CGI-BP-S scale rates the severity of the patient's illness at the time of assessment and is scored from 1 to 7 (1=normal, not ill to 7=very severely ill). Higher CGI-BP-S scores indicate greater illness severity.
Outcome measures
| Measure |
Quetiapine XR
n=92 Participants
Quetiapine XR 150 to 300mg once a day
|
Placebo
n=100 Participants
Matching placebo
|
|---|---|---|
|
Change From Baseline to Final Assessment (Day 57) in the CGI-BP-S
|
-17.2 Scores on a Scale
Standard Error 0.15
|
-1.35 Scores on a Scale
Standard Error 0.14
|
SECONDARY outcome
Timeframe: Change from Baseline to day 57The CGI-BP-C scale rates how much the patient's illness has improved or worsened compared to the phase immediately preceding treatment and is scored on a scale from 1 to 8 (1=very much improved to 7=very much worse; 8=not applicable). CGI-BP-C scores \>4 indicate worsening, while scores \<4 indicate improvement.
Outcome measures
| Measure |
Quetiapine XR
n=92 Participants
Quetiapine XR 150 to 300mg once a day
|
Placebo
n=100 Participants
Matching placebo
|
|---|---|---|
|
CGI-BP-C Score at Final Assessment (Day 57)
|
2.4 Scores on a scale
Standard Error 0.15
|
2.6 Scores on a scale
Standard Error 0.15
|
SECONDARY outcome
Timeframe: Day 57The proportion of patients with improvement of overall bipolar illness at Day 57 was calculated. Improvement defined as a CGI-BP-C of "Much" or "Very much" improved in overall bipolar illness assessment.
Outcome measures
| Measure |
Quetiapine XR
n=92 Participants
Quetiapine XR 150 to 300mg once a day
|
Placebo
n=100 Participants
Matching placebo
|
|---|---|---|
|
The Proportion of Patients at Final Assessment (Day 57) With Improvement of Overall Bipolar Illness
|
0.522 Proportions
|
0.40 Proportions
|
Adverse Events
Quetiapine XR
Placebo
Serious adverse events
| Measure |
Quetiapine XR
n=92 participants at risk
Quetiapine XR 150 to 300mg once a day
|
Placebo
n=100 participants at risk
Matching placebo
|
|---|---|---|
|
Psychiatric disorders
Agitation
|
1.1%
1/92
|
0.00%
0/100
|
|
Social circumstances
Social Stay Hospitalisation
|
0.00%
0/92
|
1.0%
1/100
|
|
Psychiatric disorders
Bipolar Disorder
|
0.00%
0/92
|
1.0%
1/100
|
|
Psychiatric disorders
Aggression
|
0.00%
0/92
|
1.0%
1/100
|
|
Psychiatric disorders
Depressive Symptoms
|
0.00%
0/92
|
1.0%
1/100
|
Other adverse events
| Measure |
Quetiapine XR
n=92 participants at risk
Quetiapine XR 150 to 300mg once a day
|
Placebo
n=100 participants at risk
Matching placebo
|
|---|---|---|
|
Nervous system disorders
Headache
|
21.7%
20/92
|
12.0%
12/100
|
|
Nervous system disorders
Sedation
|
7.6%
7/92
|
6.0%
6/100
|
|
Nervous system disorders
Dizziness
|
6.5%
6/92
|
2.0%
2/100
|
|
Nervous system disorders
Somnolence
|
6.5%
6/92
|
4.0%
4/100
|
|
Infections and infestations
Influenza
|
4.3%
4/92
|
1.0%
1/100
|
|
Infections and infestations
Nasoparyngitis
|
4.3%
4/92
|
3.0%
3/100
|
|
Infections and infestations
Gastroenteritis
|
3.3%
3/92
|
0.00%
0/100
|
|
Infections and infestations
Sinusitis
|
3.3%
3/92
|
0.00%
0/100
|
|
Infections and infestations
Urinary Tract Infection
|
3.3%
3/92
|
0.00%
0/100
|
|
Infections and infestations
Ear Infection
|
2.2%
2/92
|
0.00%
0/100
|
|
Infections and infestations
Upper respiratory Tract Infection
|
1.1%
1/92
|
2.0%
2/100
|
|
Gastrointestinal disorders
Diarrhoea
|
5.4%
5/92
|
1.0%
1/100
|
|
Gastrointestinal disorders
Nausea
|
5.4%
5/92
|
1.0%
1/100
|
|
Gastrointestinal disorders
Vomiting
|
3.3%
3/92
|
3.0%
3/100
|
|
Gastrointestinal disorders
Abdominal Pain
|
2.2%
2/92
|
3.0%
3/100
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
2.2%
2/92
|
1.0%
1/100
|
|
Gastrointestinal disorders
Constipation
|
2.2%
2/92
|
1.0%
1/100
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
2.2%
2/92
|
0.00%
0/100
|
|
General disorders
Fatigue
|
5.4%
5/92
|
2.0%
2/100
|
|
General disorders
Irritability
|
2.2%
2/92
|
5.0%
5/100
|
|
General disorders
Pyrexia
|
2.2%
2/92
|
1.0%
1/100
|
|
General disorders
Thirst
|
2.2%
2/92
|
0.00%
0/100
|
|
General disorders
Influenza like illness
|
0.00%
0/92
|
2.0%
2/100
|
|
Psychiatric disorders
Insomnia
|
2.2%
2/92
|
0.00%
0/100
|
|
Psychiatric disorders
Nightmare
|
2.2%
2/92
|
2.0%
2/100
|
|
Psychiatric disorders
Aggression
|
0.00%
0/92
|
2.0%
2/100
|
|
Metabolism and nutrition disorders
Increased Appetite
|
3.3%
3/92
|
3.0%
3/100
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
2.2%
2/92
|
2.0%
2/100
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
3.3%
3/92
|
0.00%
0/100
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/92
|
3.0%
3/100
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
0.00%
0/92
|
2.0%
2/100
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
2.2%
2/92
|
2.0%
2/100
|
|
Skin and subcutaneous tissue disorders
Dermatitis Contact
|
2.2%
2/92
|
1.0%
1/100
|
|
Injury, poisoning and procedural complications
Orthodontic Appliance Complication
|
0.00%
0/92
|
2.0%
2/100
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/92
|
2.0%
2/100
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60