Trial · NCT00807937
Proof of Concept in Patients With Generalized Anxiety Disorder (GAD)AZD7325
NCT00807937, Phase 2, Completed, AstraZeneca; results first posted 2010-10-08
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Proof of Concept in Patients With Generalized Anxiety Disorder (GAD)AZD7325. Trials, record NCT00807937. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00807937
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Proof of Concept in Patients With Generalized Anxiety Disorder (GAD)AZD7325
- NCT number
- NCT00807937
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 369 participants, actual
- Lead sponsor
- AstraZeneca
- Conditions
- Anxiety Disorders
- Interventions
- AZD7325, AZD7325, Lorazepam, Placebo
- First posted
- 2008-12-15
- Last updated
- 2010-10-08
- Results first posted
- 2010-10-08
Source ClinicalTrials.gov
Registered outcomes5
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 | Baseline to week 4 | HAM-A total score 0-56 units, 14 questions scored on scale of 0-4 (0= Not present, 4=Very severe) . Higher HAM-A scores indicate higher levels of anxiety Change : score at week 4 minus score at randomization |
| Secondary | Change in Hospital Anxiety and Depression Scale for Anxiety (HADS-A) Total Score | Baseline to week 4 | HADS-A total score 0-21 units, 0 is the best, Higher total scores indicate a higher severity of the mood or anxiety disorder Change : score at week 4 minus score at randomization |
| Secondary | Change in Psychic Anxiety Factor as Measured by HAM-A Psychic Cluster Score | Baseline to week 4 | The HAM-A psychic anxiety cluster score 0-28 units consists of 7 questions scored on scale of 0-4 (0=Not present, 4=Very severe) . Higher scores indicate higher levels of psychic anxiety disorder. Change: score at week 4 minus score at randomization |
| Secondary | Change in Somatic Symptoms as Measured by HAM-A Somatic Cluster Score | Baseline to week 4 | The HAM-A Somatic cluster score 0-28 units consists of 7 questions scored on scale of 0-4 (0=Not present, 4=Very severe ) . Higher scores indicate higher levels of psychic anxiety disorder. |
| Secondary | Change in Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q-SF) Percent Maximum Total Score | Baseline to week 4 | Q-LES-Q total score is the sum of the first 14 times of Q-LES-Q, and this total score is converted to a % maximum total score by : Q-LES-Q total score /70 x 100%, Larger values indicate a higher perceived quality of life enjoyment and satisfaction. Change : percentage at week 4 minus percentage at randomization |
Source ClinicalTrials.gov
Outcomes5
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 | Baseline to week 4 | Units on scale | LEAST_SQUARES_MEAN | |
| SECONDARY | Change in Hospital Anxiety and Depression Scale for Anxiety (HADS-A) Total Score | Baseline to week 4 | Units on scale | LEAST_SQUARES_MEAN | |
| SECONDARY | Change in Psychic Anxiety Factor as Measured by HAM-A Psychic Cluster Score | Baseline to week 4 | Units on scale | LEAST_SQUARES_MEAN | |
| SECONDARY | Change in Somatic Symptoms as Measured by HAM-A Somatic Cluster Score | Baseline to week 4 | Units on scale | LEAST_SQUARES_MEAN | |
| SECONDARY | Change in Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q-SF) Percent Maximum Total Score | Baseline to week 4 | percentage | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group20
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 | AZD7325 5 mg | -10.1 | Standard Error 0.89 | Units on scale | |
| Change in the Hamilton Rating Scale for Anxiety (HAM-A) Total Score | AZD7325 15 mg | -10.4 | Standard Error 0.89 | Units on scale | |
| Change in the Hamilton Rating Scale for Anxiety (HAM-A) Total Score | Lorazepam | -10.8 | Standard Error 0.88 | Units on scale | |
| Change in the Hamilton Rating Scale for Anxiety (HAM-A) Total Score | Placebo | -9.5 | Standard Error 0.88 | Units on scale | |
| Change in Hospital Anxiety and Depression Scale for Anxiety (HADS-A) Total Score | AZD7325 5 mg | -5.0 | Standard Error 0.51 | Units on scale | |
| Change in Hospital Anxiety and Depression Scale for Anxiety (HADS-A) Total Score | AZD7325 15 mg | -4.9 | Standard Error 0.51 | Units on scale | |
| Change in Hospital Anxiety and Depression Scale for Anxiety (HADS-A) Total Score | Lorazepam | -5.0 | Standard Error 0.51 | Units on scale | |
| Change in Hospital Anxiety and Depression Scale for Anxiety (HADS-A) Total Score | Placebo | -4.5 | Standard Error 0.50 | Units on scale | |
| Change in Psychic Anxiety Factor as Measured by HAM-A Psychic Cluster Score | AZD7325 5 mg | -5.5 | Standard Error 0.51 | Units on scale | |
| Change in Psychic Anxiety Factor as Measured by HAM-A Psychic Cluster Score | AZD7325 15 mg | -5.7 | Standard Error 0.51 | Units on scale |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | AZD7325 5 mg | 93 | |
| Overall Study | STARTED | AZD7325 15 mg | 92 | |
| Overall Study | STARTED | Lorazepam | 92 | |
| Overall Study | STARTED | Placebo | 92 | |
| Overall Study | COMPLETED | AZD7325 5 mg | 66 | |
| Overall Study | COMPLETED | AZD7325 15 mg | 67 | |
| Overall Study | COMPLETED | Lorazepam | 78 | |
| Overall Study | COMPLETED | Placebo | 77 | |
| Overall Study | NOT COMPLETED | AZD7325 5 mg | 27 | |
| Overall Study | NOT COMPLETED | AZD7325 15 mg | 25 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events64
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 | Nausea | Gastrointestinal disorders | AZD7325 5 mg | 11 | 93 | |
| other | Nausea | Gastrointestinal disorders | AZD7325 15 mg | 8 | 92 | |
| other | Nausea | Gastrointestinal disorders | Lorazepam | 7 | 92 | |
| other | Nausea | Gastrointestinal disorders | Placebo | 8 | 92 | |
| other | Diarrhoea | Gastrointestinal disorders | AZD7325 5 mg | 3 | 93 | |
| other | Diarrhoea | Gastrointestinal disorders | AZD7325 15 mg | 7 | 92 | |
| other | Diarrhoea | Gastrointestinal disorders | Lorazepam | 5 | 92 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 5 | 92 | |
| other | Dry Mouth | Gastrointestinal disorders | AZD7325 5 mg | 4 | 93 | |
| other | Dry Mouth | Gastrointestinal disorders | AZD7325 15 mg | 5 | 92 |
1 to 10 of 64Source ClinicalTrials.gov
See all 64 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | AZD7325 5 mg | ||
| Total, all-cause mortality | AZD7325 15 mg | ||
| Total, all-cause mortality | Lorazepam | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | AZD7325 5 mg | 63 | 93 |
| Total, other adverse events | AZD7325 15 mg | 59 | 92 |
| Total, other adverse events | Lorazepam | 65 | 92 |
| Total, other adverse events | Placebo | 51 | 92 |
| Total, serious adverse events | AZD7325 5 mg | 0 | 93 |
| Total, serious adverse events | AZD7325 15 mg | 0 | 92 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT00807937
GET https://conductscience.org/api/trials/v1/NCT00807937/events?page=2