Trial · NCT00389064
Efficacy and Safety Study of Seroquel SR in the Treatment of Generalised Anxiety Disorder
NCT00389064, Phase 3, Completed, AstraZeneca; results first posted 2009-06-23
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety Study of Seroquel SR in the Treatment of Generalised Anxiety Disorder. Trials, record NCT00389064. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00389064
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety Study of Seroquel SR in the Treatment of Generalised Anxiety Disorder
- NCT number
- NCT00389064
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 450 participants, actual
- Lead sponsor
- AstraZeneca
- Conditions
- Anxiety Disorders
- Interventions
- Quetiapine XR, Placebo
- First posted
- 2006-10-18
- Last updated
- 2012-04-04
- Other registries' IDs
- eudract:2006-001195-21
- Results first posted
- 2009-06-23
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in the Hamilton Rating Scale for Anxiety (HAM-A) Total Score | Randomization to Week 9 | HAM-A total score ( 0-56 units), 0 is the best, Change : score at week 9 minus score at randomization |
| Secondary | Change in Health-related Quality of Life as Measured by Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) Percent Maximum Total Score | Randomization to Week 9 | Q-LES-Q total score is the sum of the first 14 items of Q-LES-Q, and this total score is converted to a % maximum total score by : (Q-LES-Q total score -14) /56 x 100%, Larger values indicate a higher perceived quality of life enjoyment and satisfaction. Change : percentage at week 9 minus percentage at randomization |
| Secondary | Change in the Clinical Global Impression - Severity of Illness (CGI-S) Score | Randomization to Week 9 | CGI-S score is accessed on a seven-graded scale ranging from most extremely ill/ very much worse (7) to normal/very much improved (1) , 1 is best Change : score at week 9 minus score at randomization |
| Secondary | Change in Psychic Anxiety Factor as Measured by HAM-A Psychic Cluster Score | Randomization to Week 9 | HAM-A psychic cluster score ( 0-28), 0 is the best Change : score at week 9 minus score at randomization |
| Secondary | Change in Somatic Symptoms as Measured by HAM-A Somatic Cluster Score | Randomization to Week 9 | HAM-A somatic cluster score (0-28), 0 is the best Change : score at week 9 minus score at randomization |
| Secondary | Hamilton Rating Scale for Anxiety (HAM-A) Response. | Week 9 | HAM-A response, defined as 50% or greater reduction from randomization in HAM-A total score. |
| Secondary | Number of Patients Reaching Hamilton Rating Scale for Anxiety (HAM-A) Remission | Week 9 | HAM-A remission, defined as HAM-A total score less or equal to 7. An indicator of HAM-A remission is calculated as: * If HAM-A total score≤7, THEN indicator=1 * If HAM-A total score \>7, THEN indicator=0 |
| Secondary | Change in Montgomery-Asberg Depression Rating Scale (MADRS) | Randomization to week 9 | MADRS total score (0-60), 0 is best Change : score at week 9 minus score at randomization |
| Secondary | Change in the Visual Analogue Scale (VAS) Measuring Pain | Randomization to week 9 | Visual Analogue Scale (VAS) measuring pain (0-100 mm), 0 is best Change : scale at week 9 minus scale at randomization |
| Secondary | Safety and Well Tolerated as Measured in Adverse Event | From the start of treatment to last dose plus 30 days | Number of patients have at least one adverse event |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in the Hamilton Rating Scale for Anxiety (HAM-A) Total Score | Randomization to Week 9 | Modified Intent to Treat (MITT) population. | units on scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change in Health-related Quality of Life as Measured by Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) Percent Maximum Total Score | Randomization to Week 9 | In reporting Q-LES-Q there was missing data even with last observation carried forward (LOCF), so the total number of patients analyzed is 428 ( 211 Quetiapine XR and 217 Placebo). | Percentage of Maximum Total Score | LEAST_SQUARES_MEAN |
| SECONDARY | Change in the Clinical Global Impression - Severity of Illness (CGI-S) Score | Randomization to Week 9 | Modified Intent to Treat (MITT) population. | units on scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change in Psychic Anxiety Factor as Measured by HAM-A Psychic Cluster Score | Randomization to Week 9 | Modified Intent to Treat (MITT) population. | units on scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change in Somatic Symptoms as Measured by HAM-A Somatic Cluster Score | Randomization to Week 9 | Modified Intent to Treat (MITT) population. | units on scale | LEAST_SQUARES_MEAN |
| SECONDARY | Hamilton Rating Scale for Anxiety (HAM-A) Response. | Week 9 | Number of participants. | NUMBER | |
| SECONDARY | Number of Patients Reaching Hamilton Rating Scale for Anxiety (HAM-A) Remission | Week 9 | Modified Intent to Treat (MITT) population. | Number of participants. | NUMBER |
| SECONDARY | Change in Montgomery-Asberg Depression Rating Scale (MADRS) | Randomization to week 9 | Modified Intent to Treat (MITT) population. | units on scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change in the Visual Analogue Scale (VAS) Measuring Pain | Randomization to week 9 | Modified Intent to Treat (MITT) population. | mm | LEAST_SQUARES_MEAN |
| SECONDARY | Safety and Well Tolerated as Measured in Adverse Event | From the start of treatment to last dose plus 30 days | Safety population | Participants | NUMBER |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group22
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in the Hamilton Rating Scale for Anxiety (HAM-A) Total Score | Quetiapine XR | -14.97 | Standard Deviation 7.4 | units on scale | |
| Change in the Hamilton Rating Scale for Anxiety (HAM-A) Total Score | Placebo | -7.21 | Standard Deviation 7.8 | units on scale | |
| Change in Health-related Quality of Life as Measured by Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) Percent Maximum Total Score | Quetiapine XR | 14.82 | Standard Deviation 12.40 | Percentage of Maximum Total Score | |
| Change in Health-related Quality of Life as Measured by Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) Percent Maximum Total Score | Placebo | 4.94 | Standard Deviation 11.60 | Percentage of Maximum Total Score | |
| Change in the Clinical Global Impression - Severity of Illness (CGI-S) Score | Quetiapine XR | -1.76 | Standard Deviation 1.10 | units on scale | |
| Change in the Clinical Global Impression - Severity of Illness (CGI-S) Score | Placebo | -0.59 | Standard Deviation 1.00 | units on scale | |
| Change in Psychic Anxiety Factor as Measured by HAM-A Psychic Cluster Score | Quetiapine XR | -8.88 | Standard Deviation 4.20 | units on scale | |
| Change in Psychic Anxiety Factor as Measured by HAM-A Psychic Cluster Score | Placebo | -3.81 | Standard Deviation 4.60 | units on scale | |
| Change in Somatic Symptoms as Measured by HAM-A Somatic Cluster Score | Quetiapine XR | -6.05 | Standard Deviation 4.00 | units on scale | |
| Change in Somatic Symptoms as Measured by HAM-A Somatic Cluster Score | Placebo | -3.37 | Standard Deviation 3.90 | units on scale |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 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 | 223 | |
| Overall Study | STARTED | Placebo | 227 | |
| Overall Study | COMPLETED | Quetiapine XR | 178 | |
| Overall Study | COMPLETED | Placebo | 168 | |
| Overall Study | NOT COMPLETED | Quetiapine XR | 45 | |
| Overall Study | NOT COMPLETED | Placebo | 59 |
Source ClinicalTrials.gov
Adverse events18
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 | Dizziness | Nervous system disorders | Quetiapine XR | 30 | 223 | |
| other | Dizziness | Nervous system disorders | Placebo | 16 | 227 | |
| other | Dry Mouth | Gastrointestinal disorders | Quetiapine XR | 37 | 223 | |
| other | Dry Mouth | Gastrointestinal disorders | Placebo | 16 | 227 | |
| other | Headache | Nervous system disorders | Quetiapine XR | 26 | 223 | |
| other | Headache | Nervous system disorders | Placebo | 29 | 227 | |
| other | Nausea | Gastrointestinal disorders | Quetiapine XR | 20 | 223 | |
| other | Nausea | Gastrointestinal disorders | Placebo | 9 | 227 | |
| other | Somnolence | Nervous system disorders | Quetiapine XR | 58 | 223 | |
| other | Somnolence | Nervous system disorders | Placebo | 19 | 227 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 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 | 171 | 223 |
| Total, other adverse events | Placebo | 89 | 227 |
| Total, serious adverse events | Quetiapine XR | 1 | 223 |
| Total, serious adverse events | Placebo | 3 | 227 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 23070803 | DERIVED |
Source PubMed
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Quetiapine XR vs Placebo: Safety and Well Tolerated as Measured in Adverse Event | 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/NCT00389064
GET https://conductscience.org/api/trials/v1/NCT00389064/results?page=2