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AZD7325 · 8 trials · 4 indications
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
The HAM -A is a 14-item clinician administered scale for the evaluation of anxiety symptoms. Each HAM-A item is rated on a 0 (not present) to 4 (very severe) scale, higher score indicates high level of anxiety. The HAM-A total score is calculated as the sum of 14 individual scores, with 56 as the maximum.
| Arm | Type | Description |
|---|---|---|
| A | EXPERIMENTAL | AZD7325 5mg twice daily |
| B | EXPERIMENTAL | AZD7325 15mg twice daily |
| C | ACTIVE_COMPARATOR | Lorazepam 2mg twice daily |
| D | PLACEBO_COMPARATOR | Placebo |
| A-AZD7325 2mg | EXPERIMENTAL | AZD7325 2mg BID |
| B-AZD7325 5mg | EXPERIMENTAL | AZD7325 5mg BID |
| C-AZD7325 10mg | EXPERIMENTAL | AZD7325 10mg QD |
| D-Placebo | EXPERIMENTAL | Placebo |
| E | EXPERIMENTAL | AZD7325 |
| F | EXPERIMENTAL | AZD7325 |
| G | EXPERIMENTAL | AZD7325 |
| 1 | EXPERIMENTAL | - |
| 2 | PLACEBO_COMPARATOR | - |
| 3 | OTHER | AZD7325 Placebo/Lorazepam 1 mg combination therapy; washout period; AZD7325 Placebo/Lorazepam Placebo combination therapy; washout period; AZD7325 1 mg/Lorazepam Placebo combination therapy; washout period; AZD7325 10 mg/Lorazepam Placebo combination therapy |
| 4 | OTHER | AZD7325 1 mg/Lorazepam Placebo combination therapy; washout period; AZD7325 Placebo/Lorazepam 1 mg combination therapy; washout period; AZD7325 10 mg/Lorazepam Placebo combination therapy; washout period; AZD7325 Placebo/Lorazepam Placebo combination therapy |
| Name | Type | Description |
|---|---|---|
| AZD7325 | DRUG | 4 tablets and 1 capsule taken twice a day for 28 days |
| Lorazepam | DRUG | 4 tablets and 1 capsule taken twice a day for 28 days |
| Placebo | DRUG | 4 tablets and 1 capsule taken twice a day for 28 days |
| Midazolam | DRUG | single dose, twice during treatment |
| Caffeine | DRUG | single dose, twice during treatment |
| Radioligand (11C) flumazenil | DRUG | Single dose of i.v solution. 4 times per subject. (3 times together with AZD7325) |
Inclusion Criteria: * Signed informed consent before any study-related procedures start. * The patient is previously diagnosed with Generalized Anxiety Disorder. * The patient has a HADS-A (anxiety) score ≥10 at both screening and randomization. Exclusion Criteria: * Patient has a lifetime histor...
AZD7325 is an investigational small molecule being developed for anxiety and anxiety disorders. It has also been studied in healthy volunteers and in the context of recreational CNS depressant use. As of the available data, AZD7325 is in Phase 1 clinical development and is not approved by the FDA.
AZD7325 is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker symbol AZN. The drug is currently in Phase 1 clinical trials, and all known studies have been completed.
AZD7325 is in Phase 1 clinical development. All four clinical trials associated with the drug have been completed, and there are no active trials currently listed. The drug remains investigational and has not received regulatory approval.
AZD7325 has been studied in four completed Phase 1 clinical trials. These include a multiple ascending dose study (NCT00681915), a sedation and cognition study (NCT00720421), a single ascending dose study in Japanese subjects (NCT00769899), and a CYP interaction study (NCT00790114). All trials enrolled healthy volunteers.
AZD7325 is the primary name used in clinical trial records for this investigational drug. No alternative names have been identified in the available data. The drug is being studied under this identifier across all its completed Phase 1 trials.