Effectiveness of Quetiapine XR on the Control of Symptoms of Manic Phase of Bipolar Disorder. (EMMY)

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

AstraZeneca

ClinicalTrials.gov Identifier:

NCT00521365

First received: August 24, 2007

Last updated: June 12, 2012

Last verified: March 2012

History of Changes

Results First Received: August 11, 2010

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Conditions:	Bipolar Disorder Bipolar Affective Psychosis Mania Manic Disorder Manic State
Intervention:	Drug: Quetiapine 600mg

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Type I Bipolar Disorder in manic phase with a YMRS (Young Mania Rating Scale) score ≥12 at study entry. Patients of both genders, 18 - 65 years old, with bipolar disorder I according to the Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV) criteria.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups

	Description
Quetiapine 600 mg	Once the patient was enrolled, he/she was provided with a bottle that contains enough tablets of quetiapine to complete up-titration regime and whole treatment as follows: Day 1: One 300 mg tablet in the evening Day 2: Two 300 mg tablet in the evening Day 3 and onwards: Two 300 mg tablets in the evening, efforts must be done to maintain a daily dose of 600 mg/day. This study is a single arm study. All patients received quetiapine XR 600 mg.

Description

Quetiapine 600 mg

Once the patient was enrolled, he/she was provided with a bottle that contains enough tablets of quetiapine to complete up-titration regime and whole treatment as follows:

Day 1: One 300 mg tablet in the evening Day 2: Two 300 mg tablet in the evening Day 3 and onwards: Two 300 mg tablets in the evening, efforts must be done to maintain a daily dose of 600 mg/day.

This study is a single arm study. All patients received quetiapine XR 600 mg.

Participant Flow: Overall Study

	Quetiapine 600 mg
STARTED	88 ^[1]
Modified Intention to Treat (mITT)	88 ^[2]
Per Protocol (PP) Population	68 ^[3]
Safety Analysis Set	88 ^[4]
COMPLETED	68 ^[5]
NOT COMPLETED	20
Adverse Event	3
Lost to Follow-up	6
Protocol deviation	2
Drug compliance	3
Usage of not allowed drugs	6

[1]	98 participants were screened and obtain 88 patients who receive study treatment
[2]	Participants who have an YMRS assessment at inclusion, and at least one assessment after inclusion
[3]	All participants without protocol deviations
[4]	All participants who received study treatment
[5]	68 participants completed the study and 68 completed without protocol deviations

Baseline Characteristics

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Reporting Groups

	Description
Quetiapine 600 mg	Quetiapine Extended release 600 mg per day either as monotherapy or combined therapy

Baseline Measures

	Quetiapine 600 mg
Number of Participants [units: participants]	88
Age ^[1] [units: Years] Mean ± Standard Deviation	36.51 ± 12.70
Gender ^[2] [units: Participants]
Female	53
Male	35
Young Mania Rating Scale (YMRS) total score ^[3] [units: Scores on a scale] Mean ± Standard Deviation	32.06 ± 9.00
Clinical Global Impression-Severity (CGI-S) total score ^[4] [units: Scores on a scale] Mean ± Standard Deviation	5.00 ± 0.80
European Quality of Life 5 Dimensions (EQ5D) Questionnaire Index ^[5] [units: Scores on a scale] Mean ± Standard Deviation	0.54 ± 0.3
European Quality of Life 5 Dimensions (EQ5D) Questionnaire Visual Analogue Scale (VAS) ^[6] [units: Scores on a scale] Mean ± Standard Deviation	55 ± 27.8
Safety scales ^[7] [units: Scores on a scale] Mean ± Standard Deviation
SAS	1.12 ± 2.20
BARS	1.78 ± 2.40

[1]	Participants were asked for their age in years at V0
[2]	Participants were classified as male or female during V0.
[3]	Young Mania Rating Scale (YMRS) total score at visit 1(day 0). 11 item instrument with scale range 0 to 4 for 7 items and 0 to 8 for 4 items. 0 = normal; 4 or 8 = most abnormal. Total possible score is 0 - 60.
[4]	Clinical Global Impression-Severity (CGI-S) total score at visit 1( day 0). 1 item instrument with scale range 0 to 7. 0 = patients who were not assessed, 1 = Normal 7 = the most extremely ill patients.
[5]	European Quality of Life 5 Dimensions (EQ5D) Total possible score is 0-1 (0 = The worst quality of life; 1 = The best quality of life).
[6]	European Quality of Life 5 Dimensions (Eq5D) Visual Analog Scale (VAS) at visit 1(day 0). European Quality of Life 5 Dimensions (EQ5D) questionnaire part 2 has 1 item with continuous scale range 0 to 100, where 0= the worst quality of life and 100 = the best quality of life.
[7]	Simpson-Angus Scale (SAS) and Barnes Akathisia Rating Scale (BARS)total score at visit 1 (day 0). Simpson-Angus Scale (SAS) for evaluating drug-related extrapyramidal syndromes Questionnaire has 6 items with scale range 0 to 3 for each item.0=Normal; 3=Most abnormal. Total possible score is 0-18. Barnes Akathisia Rating Scale (BARS) Questionnaire has 4 items with scale range 0 to 3 for 3 items and 0 to 5 for 1 item. 0=Normal; 3 or 5=Most abnormal. Total possible score is 0-14.

Outcome Measures

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1. Primary:

Change in the Young Mania Rating Scale (YMRS) Total Score From Baseline to End of Treatment (Day 21) [ Time Frame: Baseline and 3 weeks ]

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2. Secondary:

Change in the Young Mania Rating Scale (YMRS) Total Score From Baseline to Visit 2. [ Time Frame: Baseline and 1 week ]

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3. Secondary:

Change in the Young Mania Rating Scale (YMRS) Total Score From Baseline to Visit 3 [ Time Frame: Baseline and 2 weeks ]

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4. Secondary:

Number of Participants With Young Mania Rating Scale (YMRS) Response at Final Visit or Last Observation Carried Forward (LOCF) [ Time Frame: 21 days ± 2 days or Last Observation Carried Forward ]

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5. Secondary:

Number of Participants With Young Mania Rating Scale (YMRS) Remission at Final Visit or Last Observation Carried Forward (LOCF). [ Time Frame: 21 days ± 2 days or Last Observation Carried Forward ]

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6. Secondary:

Change in the Clinical Global Impression (CGI) Total Score From Baseline (CGI-S) to Final Visit or Last Observation Carried Forward (LOCF)(CGI-I). [ Time Frame: Baseline and 3 weeks ]

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7. Secondary:

Change in the Clinical Global Impression - Improvement (CGI-I) at Final Visit or Last Observation Carried Forward (LOCF). [ Time Frame: Baseline and 3 weeks ]

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8. Secondary:

Change in the Quality of Life Questionnaire EQ5D Index From Baseline to End of the Study. [ Time Frame: Baseline and 3 weeks ]

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9. Secondary:

Change in the Quality of Life Questionnaire EQ5D Visual Analogue Scale (VAS) From Baseline to Final Visit or Last Observation Carried Forward (LOCF). [ Time Frame: Baseline and 3 weeks ]

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10. Secondary:

Change in the Simpson-Angus Scale (SAS) Total Score From Baseline to Final Visit or Last Observation Carried Forward (LOCF). [ Time Frame: Baseline and 3 weeks ]

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11. Secondary:

Change in the Barnes Akathisia Rating Scale (BARS) Total Score From Baseline to Final Visit or Last Observation Carried Forward (LOCF). [ Time Frame: Baseline and 3 weeks ]

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12. Secondary:

Change in Weight From Baseline to Final Visit or Last Observation Carried Forward (LOCF). [ Time Frame: Baseline and 3 weeks ]

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13. Secondary:

Change in Waist Circumference From Baseline to Final Visit or Last Observation Carried Forward (LOCF). [ Time Frame: Baseline and 3 weeks ]

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14. Secondary:

Number of Participants With >7% Increase in Weight [ Time Frame: Baseline and 3 weeks ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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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. Restriction Description: No text entered.

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
Open label, non comparative study

Results Point of Contact:

Name/Title: Gerard Lynch
Organization: AstraZeneca
phone: 09645895 ext 4415
e-mail: ClinicalTrialTransparency@astrazeneca.com

No publications provided

Responsible Party:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00521365 History of Changes
Other Study ID Numbers:	D1443L00017
Study First Received:	August 24, 2007
Results First Received:	August 11, 2010
Last Updated:	June 12, 2012
Health Authority:	Mexico: Ministry of Health

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