Generalized Anxiety Disorder Adjunct Study

This study has been completed.

Study NCT00534599 Information provided by AstraZeneca

First Received on September 24, 2007. Last Updated on April 12, 2011 History of Changes

Results First Received: August 13, 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
Conditions:	Anxiety Anxiety Disorders Anxiety Neuroses Anxiety States
Interventions:	Drug: Placebo Drug: quetiapine fumarate XR

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
Patient enrollment from 31 August 2007 to 02 September 2008

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Wash-out period of up to 35 days for discontinuation of prohibited medications

Reporting Groups

	Description
Quetiapine XR	50 mg to 300 mg extended release tablets once daily
Placebo	Matching placebo tablets once daily

Participant Flow: Overall Study

	Quetiapine XR	Placebo
STARTED	209 ^[1]	200 ^[1]
COMPLETED	152	168
NOT COMPLETED	57	32
Adverse Event	25	4
Incorrect enrollment	2	1
Mis-randomization	2	2
Developed study-specific d/c criteria	5	0
Lack of Efficacy	0	1
Generalized anxiety disorder worsened	0	1
Protocol Violation	1	3
Lost to Follow-up	11	14
Withdrawal by Subject	4	6
Unspecified	7	0

[1]	Randomized

Baseline Characteristics

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Reporting Groups

	Description
Quetiapine XR	50 mg to 300 mg extended release tablets once daily
Placebo	Matching placebo tablets once daily

Baseline Measures

	Quetiapine XR	Placebo	Total
Number of Participants [units: participants]	204	198	402
Age [units: Years] Mean ± Standard Deviation	46.6 ± 12.1	44.2 ± 10.9	44.4 ± 11.5
Gender [units: Participants]
Female	146	150	296
Male	58	48	106

Outcome Measures

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1. Primary:

Least Square Mean Change From Randomization to Week 8 in Hamilton Rating Scale for Anxiety (HAM-A) Total Score [ Time Frame: Baseline (randomization) and then 8 weeks ]

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2. Secondary:

Least Square Mean Change From Randomization to Week 8 in Clinical Global Impression-Severity of Illness (CGI-S) Score [ Time Frame: Baseline (randomization) and then 8 weeks ]

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3. Secondary:

Number of Patients With Clinical Global Impression-Global Improvement (CGI-I) Score of "Much/Very Much Improved" at Week 8 [ Time Frame: Baseline (randomization) and then 8 weeks ]

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4. Secondary:

Least Square Mean Change From Randomization to Week 8 in HAM-A Psychic Anxiety Subscale Score [ Time Frame: Baseline (randomization) and then 8 weeks ]

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5. Secondary:

Least Square Mean Change From Randomization to Week 8 in HAM-A Somatic Anxiety Subscale Score [ Time Frame: Baseline (randomization) and then 8 weeks ]

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6. Secondary:

Number of Patients With HAM-A Response (≥50% Score Reduction From Randomization) at Week 8 [ Time Frame: Baseline (randomization) and then 8 weeks ]

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7. Secondary:

Number of Patients With HAM-A Remission (Total Score ≤7) at Week 8 [ Time Frame: Baseline (randomization) and then 8 weeks ]

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8. Secondary:

Least Square Mean Change From Randomization to Week 8 in Quality of Life Enjoyment and Satisfaction Questionaire (Q-LES-Q) Percent Maximum Total Score [ Time Frame: Baseline (randomization) and then 8 weeks ]

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9. Secondary:

Mean Change From Randomization to Week 8 in Q-LES-Q Item 15 (Satisfaction With Medication) Score [ Time Frame: Baseline (randomization) and then 8 weeks ]

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10. Secondary:

Mean Change From Randomization to Week 8 in Q-LES-Q Item 16 (Overall Quality of Life) Score [ Time Frame: Baseline (randomization) and then 8 weeks ]

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11. Secondary:

Least Square Mean Change From Randomization to Week 1 in HAM-A Total Score [ Time Frame: Baseline (randomization) and then 8 weeks ]

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12. Secondary:

Least Square Mean Change From Randomization to Week 1 in HAM-A Psychic Anxiety Subscale Score [ Time Frame: Baseline (randomization) and then 8 weeks ]

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13. Secondary:

Least Square Mean Change From Randomization to Week 1 in HAM-A Somatic Anxiety Subscale Score [ Time Frame: Baseline (randomization) and then 8 weeks ]

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14. Secondary:

Least Square Mean Change From Randomization to Week 1 in CGI-S Score [ Time Frame: Baseline (randomization) and then 8 weeks ]

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15. Secondary:

Number of Patients With HAM-A Response (≥50% Score Reduction From Randomization) at Week 1 [ Time Frame: Baseline (randomization) and then 8 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: If Sponsor does not publish within 2 years after study completion, PI is permitted to publish, with confidential information removed from manuscript. Sponsor will have opportunity to review and approve publication at least 60 days prior to being submitted/disclosed. Sponsor can request, in writing, an additional 90 day embargo.

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:	Medical Science Director, AstraZeneca
ClinicalTrials.gov Identifier:	NCT00534599 History of Changes
Other Study ID Numbers:	D1441L00016
Study First Received:	September 24, 2007
Results First Received:	August 13, 2009
Last Updated:	April 12, 2011
Health Authority:	United States: Food and Drug Administration