A Phase 2 interventional study of AZD7325 and AZD7325 in Anxiety Disorders, sponsored by AstraZeneca. Completed at 51 sites in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2010-10-08.
Sponsored by AstraZeneca · Phase 2, Interventional, and Treatment
The purpose of this research study is to determine whether AstraZeneca's drug AZD7325 is safe and effective in the treatment of generalized anxiety disorder.
4,868 studies on the registry are indexed under Anxiety Disorders; 1,390 are open to participants now.
This study's enrollment of 369 is above the median of 80 across 4,174 interventional studies indexed under Anxiety Disorders.
Browse Anxiety Disorders studies →AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.
Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
AZD7325 5mg twice daily
Drug: AZD7325
AZD7325 15mg twice daily
Drug: AZD7325
Lorazepam 2mg twice daily
Drug: Lorazepam
Placebo
Drug: Placebo
4 tablets and 1 capsule taken twice a day for 28 days
4 tablets and 1 capsule taken twice a day for 28 days
4 tablets and 1 capsule taken twice a day for 28 days
4 tablets and 1 capsule taken twice a day for 28 days
Change in the Hamilton Rating Scale for Anxiety (HAM-A) Total Score
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
Time frame: Baseline to week 4
Change in Hospital Anxiety and Depression Scale for Anxiety (HADS-A) Total Score
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
Time frame: Baseline to week 4
Change in Psychic Anxiety Factor as Measured by HAM-A Psychic Cluster Score
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
Time frame: Baseline to week 4
Change in Somatic Symptoms as Measured by HAM-A Somatic Cluster Score
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.
Time frame: Baseline to week 4
Change in Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q-SF) Percent Maximum Total Score
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
Time frame: Baseline to week 4
International multi-center study, 43 sites recruited between Dec 2008 and May 2009
| Milestone | AZD7325 5 mg | AZD7325 15 mg | Lorazepam | Placebo |
|---|---|---|---|---|
| Started | 93 | 92 | 92 | 92 |
| Completed | 66 | 67 | 78 | 77 |
| Not completed | 27 | 25 | 14 | 15 |
| Withdrew: Adverse event | 12 | 12 | 5 | 4 |
| Withdrew: Protocol violation | 4 | 5 | 3 | 3 |
| Withdrew: Withdrawal by subject | 5 | 4 | 1 | 4 |
| Withdrew: Lost to follow-up | 4 | 0 | 2 | 1 |
| Withdrew: Lack of efficacy | 0 | 0 | 1 | 2 |
| Withdrew: Intake of prohibited medicine | 0 | 0 | 2 | 0 |
| Withdrew: All other reasons (not provided) | 2 | 4 | 0 | 1 |
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
| Units on scale | AZD7325 5 mg | AZD7325 15 mg | Lorazepam | Placebo |
|---|---|---|---|---|
| Change in the Hamilton Rating Scale for Anxiety (HAM-A) Total Score | -10.1 ± 0.89 | -10.4 ± 0.89 | -10.8 ± 0.88 | -9.5 ± 0.88 |
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
| Units on scale | AZD7325 5 mg | AZD7325 15 mg | Lorazepam | Placebo |
|---|---|---|---|---|
| Change in Hospital Anxiety and Depression Scale for Anxiety (HADS-A) Total Score | -5.0 ± 0.51 | -4.9 ± 0.51 | -5.0 ± 0.51 | -4.5 ± 0.50 |
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
| Units on scale | AZD7325 5 mg | AZD7325 15 mg | Lorazepam | Placebo |
|---|---|---|---|---|
| Change in Psychic Anxiety Factor as Measured by HAM-A Psychic Cluster Score | -5.5 ± 0.51 | -5.7 ± 0.51 | -6.0 ± 0.51 | -5.1 ± 0.51 |
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.
| Units on scale | AZD7325 5 mg | AZD7325 15 mg | Lorazepam | Placebo |
|---|---|---|---|---|
| Change in Somatic Symptoms as Measured by HAM-A Somatic Cluster Score | -4.5 ± 0.43 | -4.7 ± 0.43 | -4.9 ± 0.43 | -4.3 ± 0.43 |
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
| percentage | AZD7325 5 mg | AZD7325 15 mg | Lorazepam | Placebo |
|---|---|---|---|---|
| Change in Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q-SF) Percent Maximum Total Score | 7.79 ± 1.339 | 9.04 ± 1.338 | 7.46 ± 1.318 | 6.95 ± 1.317 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| AZD7325 5 mg | — | 0/93 (0%) | 63/93 (67.7%) |
| AZD7325 15 mg | — | 0/92 (0%) | 59/92 (64.1%) |
| Lorazepam | — | 0/92 (0%) | 65/92 (70.7%) |
| Placebo | — | 0/92 (0%) | 51/92 (55.4%) |
| Event | AZD7325 5 mg | AZD7325 15 mg | Lorazepam | Placebo |
|---|---|---|---|---|
| DizzinessNervous system disorders | 31/93 | 27/92 | 14/92 | 11/92 |
| SomnolenceNervous system disorders | 18/93 | 16/92 | 29/92 | 11/92 |
| FatigueGeneral disorders | 10/93 | 2/92 | 15/92 | 8/92 |
| HeadacheNervous system disorders | 8/93 | 8/92 | 11/92 | 11/92 |
| NauseaGastrointestinal disorders | 11/93 | 8/92 | 7/92 | 8/92 |
| Feeling AbnormalGeneral disorders | 5/93 | 8/92 | 4/92 | 3/92 |
| Euphoric MoodPsychiatric disorders | 8/93 | 7/92 | 4/92 | 1/92 |
| DiarrhoeaGastrointestinal disorders | 3/93 | 7/92 | 5/92 | 5/92 |
| SedationNervous system disorders | 3/93 | 6/92 | 7/92 | 1/92 |
| Dry MouthGastrointestinal disorders | 4/93 | 5/92 | 6/92 | 3/92 |
| Age, Customized(Participants) | AZD7325 5 mg | AZD7325 15 mg | Lorazepam | Placebo | Total |
|---|---|---|---|---|---|
| 18-39 years | 46 | 42 | 43 | 44 | 175 |
| 40-65 years | 47 | 50 | 49 | 48 | 194 |
| Sex: Female, Male(Participants) | AZD7325 5 mg | AZD7325 15 mg | Lorazepam | Placebo | Total |
|---|---|---|---|---|---|
| Female | 58 | 43 | 45 | 45 | 191 |
| Male | 35 | 49 | 47 | 47 | 178 |
This study is completed, as verified in Sep 2010. You cannot join it, but the record below documents what was studied.
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