Anxiety Clinical Trial
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
Verified date | April 2011 |
Source | AstraZeneca |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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 |
Lead Sponsor | Collaborator |
---|---|
AstraZeneca |
United States,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
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