Pediatric Bipolar Depression

This study has been completed.

Study NCT00811473 Information provided by AstraZeneca

First Received on December 18, 2008. Last Updated on October 27, 2011 History of Changes

Results First Received: October 27, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition:	Bipolar Depression
Interventions:	Drug: quetiapine XR Drug: Placebo

Participant Flow

Hide Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups

	Description
1. Quetiapine XR 150 to 300mg/Day	Quetiapine XR 150 to 300mg/day
2 - Placebo	No text entered.

Participant Flow: Overall Study

	1. Quetiapine XR 150 to 300mg/Day	2 - Placebo
STARTED	93	100
COMPLETED	70	74
NOT COMPLETED	23	26
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

Baseline Characteristics

Hide Baseline Characteristics

Reporting Groups

	Description
1. Quetiapine XR 150 to 300mg/Day	Quetiapine XR 150 to 300mg/day
2 - Placebo	No text entered.

Baseline Measures

	1. Quetiapine XR 150 to 300mg/Day	2 - Placebo	Total
Number of Participants [units: participants]	92	100	192
Age ^[1] [units: years] Mean ± Standard Deviation	13.9 ± 2.18	14.0 ± 2.05	14.0 ± 2.11
Gender ^[1] [units: participants]
Female	47	48	95
Male	45	52	97

[1]	Safety analysis set

Outcome Measures

Show All Outcome Measures

1. Primary:

Change in the CDRS-R Total Score From Baseline to Final Assessment (Day 57) [ Time Frame: Will be scored at all visits ]

Show Outcome Measure 1

2. Secondary:

Proportion of Remission, Defined as CDRS-R Total Score ≤28 at Final Assessment (Day 57) [ Time Frame: Days 8 to 57 ]

Show Outcome Measure 2

3. Secondary:

Proportion of Response, Defined as ≥50% Reduction From Baseline to Final Assessment (Day 57) in CDRS-R Total Score [ Time Frame: Days 8 to 57 ]

Show Outcome Measure 3

4. Secondary:

Change From Baseline to Final Assessment (Day 57) in the CGI-BP-S [ Time Frame: Change from Baseline to Day 57 ]

Show Outcome Measure 4

5. Secondary:

CGI-BP-C Score at Final Assessment (Day 57) [ Time Frame: Change from Baseline to day 57 ]

Show Outcome Measure 5

6. Secondary:

Proportion of Patients at Final Assessment (Day 57) With Improvement of Overall Bipolar Illness [ Time Frame: Day 57 ]

Show Outcome Measure 6

Serious Adverse Events

Show Serious Adverse Events

Other Adverse Events

Show Other Adverse Events

More Information

Hide More Information

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.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact:

Name/Title: Gerard Lynch
Organization: AstraZeneca
e-mail: aztrail_results_posting@astrazeneca.com

No publications provided

Responsible Party:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00811473 History of Changes
Other Study ID Numbers:	D144AC00001
Study First Received:	December 18, 2008
Results First Received:	October 27, 2011
Last Updated:	October 27, 2011
Health Authority:	United States: Food and Drug Administration