Efficacy and Safety Study of Seroquel SR in the Treatment of Generalised Anxiety Disorder

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

AstraZeneca

ClinicalTrials.gov Identifier:

NCT00389064

First received: October 17, 2006

Last updated: March 30, 2012

Last verified: March 2012

History of Changes

Results First Received: April 15, 2009

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

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, 47 sites recruited between Sept 2006 and Apr 2008

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 restriced medications

Reporting Groups

	Description
Quetiapine XR	Quetiapine fumerate XR - flexibly dosed (50 - 300 mg)
Placebo	No text entered.

Participant Flow: Overall Study

	Quetiapine XR	Placebo
STARTED	223	227
COMPLETED	178	168
NOT COMPLETED	45	59
Adverse Event	11	3
Lack of Efficacy	3	14
Withdrawal by Subject	17	27
Physician Decision	2	2
Lost to Follow-up	1	2
Protocol Violation	2	0
Multiple Reasons	9	11

Baseline Characteristics

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Reporting Groups

	Description
Quetiapine XR	Quetiapine fumerate XR - flexibly dosed (50 - 300 mg)
Placebo	No text entered.
Total	Total of all reporting groups

Baseline Measures

	Quetiapine XR	Placebo	Total
Number of Participants [units: participants]	223	227	450
Age, Customized [units: Participants]
66 to 75 years	197	195	392
> 75 years	26	32	58
Gender [units: Participants]
Female	161	157	318
Male	62	70	132

Outcome Measures

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1. Primary:

Change in the Hamilton Rating Scale for Anxiety (HAM-A) Total Score [ Time Frame: Randomization to Week 9 ]

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2. Secondary:

Change in Health-related Quality of Life as Measured by Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) Percent Maximum Total Score [ Time Frame: Randomization to Week 9 ]

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3. Secondary:

Change in the Clinical Global Impression - Severity of Illness (CGI-S) Score [ Time Frame: Randomization to Week 9 ]

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4. Secondary:

Change in Psychic Anxiety Factor as Measured by HAM-A Psychic Cluster Score [ Time Frame: Randomization to Week 9 ]

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5. Secondary:

Change in Somatic Symptoms as Measured by HAM-A Somatic Cluster Score [ Time Frame: Randomization to Week 9 ]

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6. Secondary:

Hamilton Rating Scale for Anxiety (HAM-A) Response. [ Time Frame: Week 9 ]

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7. Secondary:

Number of Patients Reaching Hamilton Rating Scale for Anxiety (HAM-A) Remission [ Time Frame: Week 9 ]

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8. Secondary:

Change in Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: Randomization to week 9 ]

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9. Secondary:

Change in the Visual Analogue Scale (VAS) Measuring Pain [ Time Frame: Randomization to week 9 ]

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10. Secondary:

Safety and Well Tolerated as Measured in Adverse Event [ Time Frame: From the start of treatment to last dose plus 30 days ]

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11. Secondary:

Safety and Well Tolerated as Measured by Extra Pyramidal Symptoms (EPS) [ Time Frame: From start of the study teatment to last dose plus 30 days ]

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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 regards 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: Gerard Lynch
Organization: AstraZeneca
e-mail: AZTrial_Results_Posting@astrazeneca.com

No publications provided

Responsible Party:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00389064 History of Changes
Other Study ID Numbers:	D1448C00015, EUDRACT No: 2006-001195-21
Study First Received:	October 17, 2006
Results First Received:	April 15, 2009
Last Updated:	March 30, 2012
Health Authority:	Estonia: The State Agency of Medicine Lithuania: State Medicine Control Agency - Ministry of Health Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products Russia: Ministry of Health of the Russian Federation Ukraine: State Pharmacological Center - Ministry of Health

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