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

This study has been completed.

Study NCT00389064 Information provided by AstraZeneca

First Received on October 17, 2006. Last Updated on April 15, 2009 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; Primary Purpose: Treatment
Condition:	Anxiety Disorders
Intervention:	Drug: Quetiapine

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
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	Placebo

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

Hide Baseline Characteristics

Reporting Groups

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

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

Show All Outcome Measures

1. Primary:

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

Show Outcome Measure 1

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 ]

Show Outcome Measure 2

3. Secondary:

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

Show Outcome Measure 3

4. Secondary:

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

Show Outcome Measure 4

5. Secondary:

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

Show Outcome Measure 5

6. Secondary:

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

Show Outcome Measure 6

7. Secondary:

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

Show Outcome Measure 7

8. Secondary:

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

Show Outcome Measure 8

9. Secondary:

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

Show Outcome Measure 9

10. 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 ]

Show Outcome Measure 10

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. 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:	Martin Brecher, Seroquel Medical Science Director, AstraZeneca Pharmaceuticals
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:	April 15, 2009
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 and Social Development of the Russian Federation; Ukraine: State Pharmacological Center - Ministry of Health