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Generalized Anxiety Disorder Adjunct Study

Primary Purpose

Anxiety, Anxiety Disorders, Anxiety Neuroses

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Placebo

quetiapine fumarate XR

About this trial

This is an interventional treatment trial for Anxiety focused on measuring Generalized anxiety disorders, anxiety, adjunct treatment in anxiety, anxiety disorder, partial or non-responder in anxiety

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Provision of Informed Consent

Documented diagnosis of Generalized Anxiety Disorder
Female patients must not be pregnant and be willing to use a reliable method of birth control
Be able to understand and comply with study requirements

Exclusion Criteria:

Other psychiatric disorders that could confound the study results, as judged by the study doctor

Moderate to severe depression
Other clinically relevant diseases, as judged by the study doctor
Medication that you are taking, as judged by the study doctor

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

Arm Description

Adjunctive Placebo Seroquel XR to anxiety treatment

Adjunctive Seroquel XR to anxiety treatment

Outcomes

Primary Outcome Measures

Least Square Mean Change From Randomization to Week 8 in Hamilton Rating Scale for Anxiety (HAM-A) Total Score

Hamilton Rating Scale for Anxiety (HAM-A) consists of 14 items to evaluate anxiety. Each item is rated on a scale from 0-4, with '0' showing no anxiety (not present) and '4' showing the worst (very severe). Results based on MITT population with available data for this outcome measure. Least square mean of each treatment was adjusted for baseline value.

Secondary Outcome Measures

Least Square Mean Change From Randomization to Week 8 in Clinical Global Impression-Severity of Illness (CGI-S) Score

The CGI-S is assessed on a seven-point scale ranging from most extremely ill/very much worse (7) to normal/very much improved (1). Results based on MITT population with available data for this outcome measure.

Number of Patients With Clinical Global Impression-Global Improvement (CGI-I) Score of "Much/Very Much Improved" at Week 8

This pertains to the CGI-I scale which rates improvement of anxiety on a scale from 1-7, with '1' showing the best improvement(Very Much Improved) and '7' showing the worst improvement (Very Much Worse) as compared to the baseline visit. A rating of '2' indicates 'Much Improved'. Results based on MITT population with available data for this outcome measure.

Least Square Mean Change From Randomization to Week 8 in HAM-A Psychic Anxiety Subscale Score

The HAM-A psychic anxiety factor subscale is defined as the sum of the following 7 HAM-A factors: anxious mood, tension, fears, insomnia, intellectual, depressed mood and behavior at the interview (i.e.items 1-6 and 14, respectively) Results based on MITT population with available data for this outcome measure.

Least Square Mean Change From Randomization to Week 8 in HAM-A Somatic Anxiety Subscale Score

The HAM-A Somatic cluster subscale is defined as the sum of the following 7 HAM-A items: somatic (muscular), somatic (sensory), cardiovascular symptoms, respiratory symptoms, gastrointestinal symptoms, genitourinary symptoms and autonomic system (i.e. items 7-13 respectively). Results based on MITT population with available data for this outcome measure.

Number of Patients With HAM-A Response (≥50% Score Reduction From Randomization) at Week 8

Hamilton Rating Scale for Anxiety (HAM-A) response is derived from the HAM-A total score and is defined as a decrease from baseline total HAM-A score of at least 50%. (1=Yes, 0=No) Results based on MITT population with available data for this outcome measure.

Number of Patients With HAM-A Remission (Total Score ≤7) at Week 8

Hamilton Rating Scale for Anxiety (HAM-A) remission is derived from the HAM-A total score and is defined as a HAM-A total score of ≤7. 1=Yes, 0=No Results based on MITT population with available data for this outcome measure.

Least Square Mean Change From Randomization to Week 8 in Quality of Life Enjoyment and Satisfaction Questionaire (Q-LES-Q) Percent Maximum Total Score

The Q-LES-Q score is the sum of the first 14 items, larger values indicating a higher perceived quality of life enjoyment and satisfaction. This total score was converted to a % maximum score using the following scoring conversion: %Maximum score = (Total score-14)*(100/560)rounded to an integer. Results based on MITT population with available data for this outcome measure.

Mean Change From Randomization to Week 8 in Q-LES-Q Item 15 (Satisfaction With Medication) Score

Results based on MITT population with available data for this outcome measure.

Mean Change From Randomization to Week 8 in Q-LES-Q Item 16 (Overall Quality of Life) Score

Results based on MITT population with available data for this outcome measure.

Least Square Mean Change From Randomization to Week 1 in HAM-A Total Score

Least Square Mean Change From Randomization to Week 1 in HAM-A Psychic Anxiety Subscale Score

Hamilton Rating Scale for Anxiety (HAM-A) consists of 14 items to evaluate anxiety. Each item is rated on a scale from 0-4, with '0' showing no anxiety (not present) and '4' showing the worst (very severe).Results based on MITT population with available data for this outcome measure.

Least Square Mean Change From Randomization to Week 1 in HAM-A Somatic Anxiety Subscale Score

Least Square Mean Change From Randomization to Week 1 in CGI-S Score

Results based on MITT population with available data for this outcome measure.

Number of Patients With HAM-A Response (≥50% Score Reduction From Randomization) at Week 1

Full Information

NCT ID

NCT00534599

First Posted

September 24, 2007

Last Updated

April 12, 2011

Sponsor

AstraZeneca

1. Study Identification

Unique Protocol Identification Number

NCT00534599

Brief Title

Generalized Anxiety Disorder Adjunct Study

Official Title

A Multicenter, Rand., Double-blind, Parallel-group, Pbo-controlled Study of the Efficacy and Safety of SEROQUEL® XR Compared With Pbo as an Adjunct to Treatment in Patients With Generalized Anxiety Disorder Who Demonstrate Partial or No Response to a SSRI or SNRI Alone or in Combination With a Benzo

Study Type

Interventional

2. Study Status

Record Verification Date

April 2011

Overall Recruitment Status

Completed

Study Start Date

August 2007 (undefined)

Primary Completion Date

September 2008 (Actual)

Study Completion Date

September 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

AstraZeneca

4. Oversight

5. Study Description

Brief Summary

This study is being carried out to see if extended release quetiapine fumarate (Seroquel®XL) when added to standard selective serotonin reuptake inhibitor (SSRI) / serotonin-norepinephrine reuptake inhibitor (SNRI) therapy is effective and safe for the treatment of Generalized Anxiety Disorder in patients with partial or no response to SSRI/SNRI alone or in combination with a benzodiazepine, and if so, how it compares with placebo

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Anxiety, Anxiety Disorders, Anxiety Neuroses, Anxiety States

Keywords

Generalized anxiety disorders, anxiety, adjunct treatment in anxiety, anxiety disorder, partial or non-responder in anxiety

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

409 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Other

Arm Description

Adjunctive Placebo Seroquel XR to anxiety treatment

Arm Title

Arm Type

Experimental

Arm Description

Adjunctive Seroquel XR to anxiety treatment

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

oral

Intervention Type

Drug

Intervention Name(s)

quetiapine fumarate XR

Other Intervention Name(s)

Seroquel XR

Intervention Description

oral

Primary Outcome Measure Information:

Title

Least Square Mean Change From Randomization to Week 8 in Hamilton Rating Scale for Anxiety (HAM-A) Total Score

Description

Time Frame