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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00534599
Other study ID # D1441L00016
Secondary ID
Status Completed
Phase Phase 3
First received September 24, 2007
Last updated April 12, 2011
Start date August 2007
Est. completion date September 2008

Study information

Verified date April 2011
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

Status Completed
Enrollment 409
Est. completion date September 2008
Est. primary completion date September 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Intervention

Drug:
Placebo
oral
quetiapine fumarate XR
oral

Locations

Country Name City State
United States Research Site Atlanta Georgia
United States Research Site Bellevue Washington
United States Research Site Beverly Hills California
United States Research Site Birmingham Alabama
United States Research Site Boston Massachusetts
United States Research Site Bradenton Florida
United States Research Site Brooklyn New York
United States Research Site Cedarhurst New York
United States Research Site Cherry Hill New Jersey
United States Research Site Chicago Illinois
United States Research Site Clementon New Jersey
United States Research Site Columbus Georgia
United States Research Site Dayton Florida
United States Research Site Encino California
United States Research Site Fresh Meadows New York
United States Research Site Fresno California
United States Research Site Hialeah Florida
United States Research Site Houston Texas
United States Research Site Jacksonville Florida
United States Research Site La Mesa California
United States Research Site Lafayette Indiana
United States Research Site Little Rock Arkansas
United States Research Site Maitland Florida
United States Research Site Memphis Tennessee
United States Research Site Merrillville Indiana
United States Research Site Miami Florida
United States Research Site New Orleans Louisiana
United States Research Site New York New York
United States Research Site North Miami Florida
United States Research Site Oceanside California
United States Research Site Oklahoma City Oklahoma
United States Research Site Orlando Florida
United States Research Site Owenboro Kentucky
United States Research Site Philadelphia Pennsylvania
United States Research Site Portland Oregon
United States Research Site Prairie Village Kansas
United States Research Site Redlands California
United States Research Site Richmond Virginia
United States Research Site Rochester New York
United States Research Site Rockville Maryland
United States Research Site Salem Oregon
United States Research Site San Antonio Texas
United States Research Site San Diego California
United States Research Site San Francisco California
United States Research Site Seattle Washington
United States Research Site Sherman Oaks California
United States Research Site Spokane Washington
United States Research Site Staten Island New York
United States Research Site Tampa Florida
United States Research Site Terre Haute Indiana
United States Research Site Toledo Ohio
United States Research Site West Palm Beach Florida
United States Research Site Witchita Falls Texas

Sponsors (1)

Lead Sponsor Collaborator
AstraZeneca

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
Baseline (randomization) and then 8 weeks No
Secondary 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.
Baseline (randomization) and then 8 weeks No
Secondary 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.
Baseline (randomization) and then 8 weeks No
Secondary 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. Baseline (randomization) and then 8 weeks No
Secondary 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.
Baseline (randomization) and then 8 weeks No
Secondary 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. Baseline (randomization) and then 8 weeks No
Secondary 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. Baseline (randomization) and then 8 weeks No
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 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.
Baseline (randomization) and then 8 weeks No
Secondary 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. Baseline (randomization) and then 8 weeks No
Secondary 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. Baseline (randomization) and then 8 weeks No
Secondary Least Square Mean Change From Randomization to Week 1 in 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.
Baseline (randomization) and then 8 weeks No
Secondary 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. Baseline (randomization) and then 8 weeks No
Secondary Least Square Mean Change From Randomization to Week 1 in HAM-A Somatic 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.
Baseline (randomization) and then 8 weeks No
Secondary 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. Baseline (randomization) and then 8 weeks No
Secondary Number of Patients With HAM-A Response (=50% Score Reduction From Randomization) at Week 1 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.
Baseline (randomization) and then 8 weeks No
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