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Pediatric Bipolar Depression

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ClinicalTrials.gov Identifier: NCT00811473
Recruitment Status : Completed
First Posted : December 19, 2008
Results First Posted : December 1, 2011
Last Update Posted : July 15, 2014
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Bipolar Depression
Interventions Drug: Quetiapine XR
Drug: Placebo
Enrollment 193
Recruitment Details 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.
Pre-assignment Details 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.
Arm/Group Title Quetiapine XR Placebo
Hide Arm/Group Description Quetiapine XR 150 to 300mg once a day Matching placebo
Period Title: Overall Study
Started 93 100
Completed 70 74
Not Completed 23 26
Reason Not Completed
Adverse Event             3             12
Lost to Follow-up             5             1
Withdrawal by Subject             2             4
Severe non-compliance to protocol             2             4
Lack of therapeutic response             4             1
Condition under investigation worsened             1             3
Other 2             4             1
Incorrect Enrollment             1             0
Safety Reasons             1             0
Arm/Group Title Quetiapine XR Placebo Total
Hide Arm/Group Description Quetiapine XR 150 to 300mg once a day Matching placebo Total of all reporting groups
Overall Number of Baseline Participants 92 100 192
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 92 participants 100 participants 192 participants
13.9  (2.18) 14.0  (2.05) 14.0  (2.11)
[1]
Measure Description: Safety analysis set
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 92 participants 100 participants 192 participants
Female
47
  51.1%
48
  48.0%
95
  49.5%
Male
45
  48.9%
52
  52.0%
97
  50.5%
[1]
Measure Description: Safety analysis set
1.Primary Outcome
Title Change in the Children Depression Rating Scale, Revised (CDRS-R) Total Score From Baseline to Final Assessment (Day 57)
Hide Description 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).
Time Frame Will be scored at all visits. the analysis is the change from baseline to the final assessment at day 57
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Quetiapine XR Placebo
Hide Arm/Group Description:
Quetiapine XR 150 to 300mg once a day
Matching placebo
Overall Number of Participants Analyzed 92 100
Least Squares Mean (Standard Error)
Unit of Measure: Scores on a scale
-29.6  (1.65) -27.3  (1.60)
2.Secondary Outcome
Title Number of Patients Reaching Remission Where Remission is Defined as CDRS-R Total Score ≤28 at Final Assessment (Day 57).
Hide Description The 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).
Time Frame Days 8 to 57
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Quetiapine XR Placebo
Hide Arm/Group Description:
Quetiapine XR 150 to 300mg once a day
Matching placebo
Overall Number of Participants Analyzed 92 100
Measure Type: Number
Unit of Measure: participants
42 34
3.Secondary Outcome
Title 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
Hide Description The 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).
Time Frame Days 8 to 57
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Quetiapine XR Placebo
Hide Arm/Group Description:
Quetiapine XR 150 to 300mg once a day
Matching placebo
Overall Number of Participants Analyzed 92 100
Measure Type: Number
Unit of Measure: participants
58 55
4.Secondary Outcome
Title Change From Baseline to Final Assessment (Day 57) in the CGI-BP-S
Hide Description The 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.
Time Frame Change from Baseline to Day 57
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Quetiapine XR Placebo
Hide Arm/Group Description:
Quetiapine XR 150 to 300mg once a day
Matching placebo
Overall Number of Participants Analyzed 92 100
Least Squares Mean (Standard Error)
Unit of Measure: Scores on a Scale
-17.2  (0.15) -1.35  (0.14)
5.Secondary Outcome
Title CGI-BP-C Score at Final Assessment (Day 57)
Hide Description The 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.
Time Frame Change from Baseline to day 57
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Quetiapine XR Placebo
Hide Arm/Group Description:
Quetiapine XR 150 to 300mg once a day
Matching placebo
Overall Number of Participants Analyzed 92 100
Least Squares Mean (Standard Error)
Unit of Measure: Scores on a scale
2.4  (0.15) 2.6  (0.15)
6.Secondary Outcome
Title The Proportion of Patients at Final Assessment (Day 57) With Improvement of Overall Bipolar Illness
Hide Description The 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.
Time Frame Day 57
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Quetiapine XR Placebo
Hide Arm/Group Description:
Quetiapine XR 150 to 300mg once a day
Matching placebo
Overall Number of Participants Analyzed 92 100
Measure Type: Number
Unit of Measure: Proportions
0.522 0.40
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Quetiapine XR Placebo
Hide Arm/Group Description Quetiapine XR 150 to 300mg once a day Matching placebo
All-Cause Mortality
Quetiapine XR Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Quetiapine XR Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   1   4 
Psychiatric disorders     
Agitation  1  1/92 (1.09%)  0/100 (0.00%) 
Bipolar Disorder  2  0/92 (0.00%)  1/100 (1.00%) 
Aggression  2  0/92 (0.00%)  1/100 (1.00%) 
Depressive Symptoms  2  0/92 (0.00%)  1/100 (1.00%) 
Social circumstances     
Social Stay Hospitalisation  2  0/92 (0.00%)  1/100 (1.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.0
2
Term from vocabulary, MedDRA (12.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Quetiapine XR Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   68/92 (73.91%)   66/100 (66.00%) 
Blood and lymphatic system disorders     
Neutropenia  1  0/92 (0.00%)  2/100 (2.00%) 
Gastrointestinal disorders     
Diarrhoea  1  5/92 (5.43%)  1/100 (1.00%) 
Nausea  1  5/92 (5.43%)  1/100 (1.00%) 
Vomiting  1  3/92 (3.26%)  3/100 (3.00%) 
Abdominal Pain  1  2/92 (2.17%)  3/100 (3.00%) 
Abdominal Pain Upper  1  2/92 (2.17%)  1/100 (1.00%) 
Constipation  1  2/92 (2.17%)  1/100 (1.00%) 
Gastrooesophageal Reflux Disease  1  2/92 (2.17%)  0/100 (0.00%) 
General disorders     
Fatigue  1  5/92 (5.43%)  2/100 (2.00%) 
Irritability  1  2/92 (2.17%)  5/100 (5.00%) 
Pyrexia  1  2/92 (2.17%)  1/100 (1.00%) 
Thirst  1  2/92 (2.17%)  0/100 (0.00%) 
Influenza like illness  1  0/92 (0.00%)  2/100 (2.00%) 
Infections and infestations     
Influenza  1  4/92 (4.35%)  1/100 (1.00%) 
Nasoparyngitis  1  4/92 (4.35%)  3/100 (3.00%) 
Gastroenteritis  1  3/92 (3.26%)  0/100 (0.00%) 
Sinusitis  1  3/92 (3.26%)  0/100 (0.00%) 
Urinary Tract Infection  1  3/92 (3.26%)  0/100 (0.00%) 
Ear Infection  1  2/92 (2.17%)  0/100 (0.00%) 
Upper respiratory Tract Infection  1  1/92 (1.09%)  2/100 (2.00%) 
Injury, poisoning and procedural complications     
Orthodontic Appliance Complication  1  0/92 (0.00%)  2/100 (2.00%) 
Metabolism and nutrition disorders     
Increased Appetite  1  3/92 (3.26%)  3/100 (3.00%) 
Decreased Appetite  1  2/92 (2.17%)  2/100 (2.00%) 
Nervous system disorders     
Headache  1  20/92 (21.74%)  12/100 (12.00%) 
Sedation  1  7/92 (7.61%)  6/100 (6.00%) 
Dizziness  1  6/92 (6.52%)  2/100 (2.00%) 
Somnolence  1  6/92 (6.52%)  4/100 (4.00%) 
Psychiatric disorders     
Insomnia  1  2/92 (2.17%)  0/100 (0.00%) 
Nightmare  1  2/92 (2.17%)  2/100 (2.00%) 
Aggression  1  0/92 (0.00%)  2/100 (2.00%) 
Reproductive system and breast disorders     
Dysmenorrhoea  1  2/92 (2.17%)  2/100 (2.00%) 
Respiratory, thoracic and mediastinal disorders     
Epistaxis  1  3/92 (3.26%)  0/100 (0.00%) 
Cough  1  0/92 (0.00%)  3/100 (3.00%) 
Oropharyngeal Pain  1  0/92 (0.00%)  2/100 (2.00%) 
Skin and subcutaneous tissue disorders     
Dermatitis Contact  1  2/92 (2.17%)  1/100 (1.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (12.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Gerard Lynch
Organization: AstraZeneca
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00811473     History of Changes
Other Study ID Numbers: D144AC00001
First Submitted: December 18, 2008
First Posted: December 19, 2008
Results First Submitted: October 27, 2011
Results First Posted: December 1, 2011
Last Update Posted: July 15, 2014