Trial · NCT00534599
Generalized Anxiety Disorder Adjunct Study
NCT00534599, Phase 3, Completed, AstraZeneca; results first posted 2011-04-05
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Generalized Anxiety Disorder Adjunct Study. Trials, record NCT00534599. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00534599
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Generalized Anxiety Disorder Adjunct Study
- NCT number
- NCT00534599
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 409 participants, actual
- Lead sponsor
- AstraZeneca
- Conditions
- Anxiety, Anxiety Disorders, Anxiety Neuroses, Anxiety States
- Interventions
- Placebo, quetiapine fumarate XR
- First posted
- 2007-09-26
- Last updated
- 2011-04-14
- Results first posted
- 2011-04-05
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Least Square Mean Change From Randomization to Week 8 in Hamilton Rating Scale for Anxiety (HAM-A) Total Score | 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. |
| Secondary | Least Square Mean Change From Randomization to Week 8 in Clinical Global Impression-Severity of Illness (CGI-S) Score | 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. |
| Secondary | Number of Patients With Clinical Global Impression-Global Improvement (CGI-I) Score of "Much/Very Much Improved" at Week 8 | 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. |
| Secondary | Least Square Mean Change From Randomization to Week 8 in HAM-A Psychic Anxiety Subscale Score | 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. |
| Secondary | Least Square Mean Change From Randomization to Week 8 in HAM-A Somatic Anxiety Subscale Score | 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. |
| Secondary | Number of Patients With HAM-A Response (≥50% Score Reduction From Randomization) at Week 8 | 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. |
| Secondary | Number of Patients With HAM-A Remission (Total Score ≤7) at Week 8 | 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. |
| 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 | 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. |
| Secondary | Mean Change From Randomization to Week 8 in Q-LES-Q Item 15 (Satisfaction With Medication) Score | Baseline (randomization) and then 8 weeks | Results based on MITT population with available data for this outcome measure. |
| Secondary | Mean Change From Randomization to Week 8 in Q-LES-Q Item 16 (Overall Quality of Life) Score | Baseline (randomization) and then 8 weeks | Results based on MITT population with available data for this outcome measure. |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Least Square Mean Change From Randomization to Week 8 in Hamilton Rating Scale for Anxiety (HAM-A) Total Score | Baseline (randomization) and then 8 weeks | Results participant numbers are based on Modified Intention to Treat (MITT) population set; The participants in the overall study are participants randomized. | units on scale | LEAST_SQUARES_MEAN |
| SECONDARY | Least Square Mean Change From Randomization to Week 8 in Clinical Global Impression-Severity of Illness (CGI-S) Score | Baseline (randomization) and then 8 weeks | LS mean change from randomization | LEAST_SQUARES_MEAN | |
| SECONDARY | Number of Patients With Clinical Global Impression-Global Improvement (CGI-I) Score of Much/Very Much Improved at Week 8 | Baseline (randomization) and then 8 weeks | Participants | NUMBER | |
| SECONDARY | Least Square Mean Change From Randomization to Week 8 in HAM-A Psychic Anxiety Subscale Score | Baseline (randomization) and then 8 weeks | LS mean change from randomization | LEAST_SQUARES_MEAN | |
| SECONDARY | Least Square Mean Change From Randomization to Week 8 in HAM-A Somatic Anxiety Subscale Score | Baseline (randomization) and then 8 weeks | LS mean change from randomization | LEAST_SQUARES_MEAN | |
| SECONDARY | Number of Patients With HAM-A Response (≥50% Score Reduction From Randomization) at Week 8 | Baseline (randomization) and then 8 weeks | Participants | NUMBER | |
| SECONDARY | Number of Patients With HAM-A Remission (Total Score ≤7) at Week 8 | Baseline (randomization) and then 8 weeks | Participants | NUMBER | |
| 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 | Baseline (randomization) and then 8 weeks | LS mean change from randomization | LEAST_SQUARES_MEAN | |
| SECONDARY | Mean Change From Randomization to Week 8 in Q-LES-Q Item 15 (Satisfaction With Medication) Score | Baseline (randomization) and then 8 weeks | Mean change from randomization | MEAN | |
| SECONDARY | Mean Change From Randomization to Week 8 in Q-LES-Q Item 16 (Overall Quality of Life) Score | Baseline (randomization) and then 8 weeks | Mean change from randomization | MEAN |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group30
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Least Square Mean Change From Randomization to Week 8 in Hamilton Rating Scale for Anxiety (HAM-A) Total Score | Quetiapine XR | -10.74 | 95% Confidence Interval -12.01 to -9.47 | units on scale | |
| Least Square Mean Change From Randomization to Week 8 in Hamilton Rating Scale for Anxiety (HAM-A) Total Score | Placebo | -9.61 | 95% Confidence Interval -10.89 to -8.32 | units on scale | |
| Least Square Mean Change From Randomization to Week 8 in Clinical Global Impression-Severity of Illness (CGI-S) Score | Quetiapine XR | -1.36 | 95% Confidence Interval -1.56 to -1.15 | LS mean change from randomization | |
| Least Square Mean Change From Randomization to Week 8 in Clinical Global Impression-Severity of Illness (CGI-S) Score | Placebo | -1.13 | 95% Confidence Interval -1.34 to -0.93 | LS mean change from randomization | |
| Number of Patients With Clinical Global Impression-Global Improvement (CGI-I) Score of Much/Very Much Improved at Week 8 | Quetiapine XR | 114 | Participants | ||
| Number of Patients With Clinical Global Impression-Global Improvement (CGI-I) Score of Much/Very Much Improved at Week 8 | Placebo | 97 | Participants | ||
| Least Square Mean Change From Randomization to Week 8 in HAM-A Psychic Anxiety Subscale Score | Quetiapine XR | -6.09 | 95% Confidence Interval -6.81 to -5.37 | LS mean change from randomization | |
| Least Square Mean Change From Randomization to Week 8 in HAM-A Psychic Anxiety Subscale Score | Placebo | -5.21 | 95% Confidence Interval -5.94 to -4.49 | LS mean change from randomization | |
| Least Square Mean Change From Randomization to Week 8 in HAM-A Somatic Anxiety Subscale Score | Quetiapine XR | -4.63 | 95% Confidence Interval -5.25 to -4.02 | LS mean change from randomization | |
| Least Square Mean Change From Randomization to Week 8 in HAM-A Somatic Anxiety Subscale Score | Placebo | -4.38 | 95% Confidence Interval -5.0 to -3.75 | LS mean change from randomization |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Quetiapine XR | 209 | |
| Overall Study | STARTED | Placebo | 200 | |
| Overall Study | COMPLETED | Quetiapine XR | 152 | |
| Overall Study | COMPLETED | Placebo | 168 | |
| Overall Study | NOT COMPLETED | Quetiapine XR | 57 | |
| Overall Study | NOT COMPLETED | Placebo | 32 |
Source ClinicalTrials.gov
Adverse events292
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Quetiapine XR | 0 | 209 | |
| other | Anaemia | Blood and lymphatic system disorders | Placebo | 1 | 200 | |
| other | Palpitations | Cardiac disorders | Quetiapine XR | 3 | 209 | |
| other | Palpitations | Cardiac disorders | Placebo | 1 | 200 | |
| other | Sinus Arrhythmia | Cardiac disorders | Quetiapine XR | 0 | 209 | |
| other | Sinus Arrhythmia | Cardiac disorders | Placebo | 1 | 200 | |
| other | Supraventricular Extrasystoles | Cardiac disorders | Quetiapine XR | 1 | 209 | |
| other | Supraventricular Extrasystoles | Cardiac disorders | Placebo | 0 | 200 | |
| other | Tinnitus | Ear and labyrinth disorders | Quetiapine XR | 2 | 209 | |
| other | Tinnitus | Ear and labyrinth disorders | Placebo | 1 | 200 |
1 to 10 of 292Source ClinicalTrials.gov
See all 292 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Quetiapine XR | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Quetiapine XR | 154 | 209 |
| Total, other adverse events | Placebo | 120 | 200 |
| Total, serious adverse events | Quetiapine XR | 0 | 209 |
| Total, serious adverse events | Placebo | 0 | 200 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons5
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Quetiapine XR vs Placebo: Number of Patients With HAM-A Response (≥50% Score Reduction From Randomization) at Week 1 | Trial comparisons |
| Quetiapine XR vs Placebo: Number of Patients With HAM-A Remission (Total Score ≤7) at Week 8 | Trial comparisons |
| Quetiapine XR vs Placebo: Number of Patients With HAM-A Response (≥50% Score Reduction From Randomization) at Week 8 | Trial comparisons |
| Quetiapine XR vs Placebo: Number of Patients With Clinical Global Impression-Global Improvement (CGI-I) Score of Much/Very Much Improved at Week 8 | Trial comparisons |
| Quetiapine XR vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00534599
GET https://conductscience.org/api/trials/v1/NCT00534599/results?page=2