Generalized Anxiety Disorder Adjunct Study
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| ClinicalTrials.gov Identifier: NCT00534599 |
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Recruitment Status
:
Completed
First Posted
: September 26, 2007
Results First Posted
: April 5, 2011
Last Update Posted
: April 14, 2011
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Anxiety Anxiety Disorders Anxiety Neuroses Anxiety States | Drug: Placebo Drug: quetiapine fumarate XR | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 409 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| 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 Start Date : | August 2007 |
| Actual Primary Completion Date : | September 2008 |
| Actual Study Completion Date : | September 2008 |
| Arm | Intervention/treatment |
|---|---|
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1
Adjunctive Placebo Seroquel XR to anxiety treatment
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Drug: Placebo
oral
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Experimental: 2
Adjunctive Seroquel XR to anxiety treatment
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Drug: quetiapine fumarate XR
oral
Other Name: Seroquel XR
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- 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 ]
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.
- 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 ]
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 [ Time Frame: Baseline (randomization) and then 8 weeks ]
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 [ Time Frame: Baseline (randomization) and then 8 weeks ]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 [ Time Frame: Baseline (randomization) and then 8 weeks ]
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 [ Time Frame: Baseline (randomization) and then 8 weeks ]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 [ Time Frame: Baseline (randomization) and then 8 weeks ]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 [ Time Frame: Baseline (randomization) and then 8 weeks ]
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 [ Time Frame: Baseline (randomization) and then 8 weeks ]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 [ Time Frame: Baseline (randomization) and then 8 weeks ]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 [ Time Frame: Baseline (randomization) and then 8 weeks ]
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 Psychic Anxiety Subscale Score [ Time Frame: Baseline (randomization) and then 8 weeks ]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 [ Time Frame: Baseline (randomization) and then 8 weeks ]
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 CGI-S Score [ Time Frame: Baseline (randomization) and then 8 weeks ]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 [ Time Frame: Baseline (randomization) and then 8 weeks ]
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.
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| Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00534599
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| Study Director: | Martin Brecher, MD | AstraZeneca |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Medical Science Director, AstraZeneca |
| ClinicalTrials.gov Identifier: | NCT00534599 History of Changes |
| Other Study ID Numbers: |
D1441L00016 |
| First Posted: | September 26, 2007 Key Record Dates |
| Results First Posted: | April 5, 2011 |
| Last Update Posted: | April 14, 2011 |
| Last Verified: | April 2011 |
Keywords provided by AstraZeneca:
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Generalized anxiety disorders anxiety adjunct treatment in anxiety anxiety disorder partial or non-responder in anxiety |
Additional relevant MeSH terms:
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Disease Anxiety Disorders Pathologic Processes Mental Disorders Quetiapine Fumarate |
Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Physiological Effects of Drugs Psychotropic Drugs |