Efficacy and Safety Study of Seroquel SR in the Treatment of Major Depressive Disorder

This study has been completed.

Sponsor:

Information provided by:

AstraZeneca

ClinicalTrials.gov Identifier:

NCT00388973

First received: October 16, 2006

Last updated: March 22, 2010

Last verified: March 2010

History of Changes

Results First Received: December 29, 2008

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double-Blind; Primary Purpose: Treatment
Condition:	Major Depressive Disorder
Intervention:	Drug: Quetiapine

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
International multi-center study, 53 sites recruited between Sept 2006 and Dec 2007

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Screening for eligibility and wash-out of restricted medications. At least moderate depression symptoms assessed by the Hamilton Rating Scale for Depression

Reporting Groups

	Description
Quetiapine XR	Quetiapine fumarate XR - flexibly dosed (50 - 300 mg)
Placebo	Placebo

Participant Flow: Overall Study

	Quetiapine XR	Placebo
STARTED	166 ^[1]	172 ^[1]
Completed Study	110	114
COMPLETED	110 ^[2]	114 ^[2]
NOT COMPLETED	56	58
Adverse Event	16	6
Lack of Efficacy	1	12
Protocol Violation	3	0
Withdrawal by Subject	14	17
Study specific Discontinuation Criteria	0	1
Did not complete 61 days of treatment	5	4
Left region	0	1
Did not complete 2-week follow-up visit	17	17

[1]	Randomized
[2]	Completed 9-week treatment and 2 week follow-up

Baseline Characteristics

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Reporting Groups

	Description
Quetiapine XR	Quetiapine fumarate XR - flexibly dosed (50 - 300 mg)
Placebo	Placebo
Total	Total of all reporting groups

Baseline Measures

	Quetiapine XR	Placebo	Total
Number of Participants [units: participants]	166	172	338
Age, Customized [units: Participants]
66 to 75 years	135	137	272
>75 years	31	35	66
Gender [units: Participants]
Female	116	120	236
Male	50	52	102
Region of Enrollment [units: Participants]
Europe	124	126	250
North America	24	27	51
South America	18	19	37
DSM IV diagnosis [units: Participants]
296.2x - Major depressive disorder, single episode	27	25	52
296.3x - Major depressive disorder, recurrent	139	147	286

Outcome Measures

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1. Primary:

Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score to Week 9. [ Time Frame: Baseline to Week 9 ]

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2. Secondary:

Change From Baseline in Health-related Quality of Life, Enjoyment and Satisfaction (Q-LES-Q) [ Time Frame: Baseline to Week 9 ]

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3. Secondary:

Change From Baseline for Satisfaction With Medication From Quality of Life, Enjoyment, Satisfaction Questionaire (Q-LES-Q) [ Time Frame: Baseline to Week 9 ]

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4. Secondary:

Change From Baseline in Anxiety Symptoms Measured by Hamilton Anxiety 14 Item Scale (HAM-A) [ Time Frame: Baseline to Week 9 ]

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5. Secondary:

Change From Baseline in Sleep Quality as Measured by the Pittsburgh Sleep Quality Index [ Time Frame: Baseline to Week 9 ]

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6. Secondary:

Change From Baseline in Suicidal Thoughts as Measured by Montgomery-Asberg Depression Rating Scale (MADRS) Item 10 [ Time Frame: Baseline to Week 9 ]

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7. Secondary:

Change From Baseline in Somatic Symptoms Cluster From the Hamilton Anxiety Scale (HAM-A) [ Time Frame: Baseline to Week 9 ]

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8. Secondary:

Tolerability as Measured by Adverse Event Withdrawals During Treatment [ Time Frame: Baseline to Week 9 ]

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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: The PI agrees to collaborate in good faith with AstraZeneca with regard to the contents and formation of any publication or disclosure to be made by the PI and to pay due consideration to the comments, views and opinions offered by AstraZeneca.

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: Medical Science Director, Seroquel
Organization: AstraZeneca
e-mail: AZTrial_Results_Posting@astrazeneca.com

No publications provided

Responsible Party:	Martin Brecher, Seroquel Medical Science Director, AstraZeneca Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00388973 History of Changes
Other Study ID Numbers:	D1448C00014, EUDRACT No: 2006-001196-38
Study First Received:	October 16, 2006
Results First Received:	December 29, 2008
Last Updated:	March 22, 2010
Health Authority:	Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica Finland: Finnish Medicines Agency Estonia: The State Agency of Medicine Lithuania: State Medicine Control Agency - Ministry of Health Russia: Ministry of Health of the Russian Federation Ukraine: Ministry of Health

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