Phase 2
Completed N=424
AZD7325 Proof of Concept in Patients With Generalized Anxiety Disorder (GAD)
Source: ClinicalTrials.gov NCT00808249 ↗Enrolled (actual)
424
Serious AEs
—
Results posted
May 2011
Primary outcomePrimary: Change From Baseline in the Hamilton Rating Scale for Anxiety (HAM-A) Total Score — -10.9; -11.1; -11.5; -10.9 Units on scale
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in the Hamilton Rating Scale for Anxiety (HAM-A) Total Score |
-10.9; -11.1; -11.5; -10.9 | — |
| SECONDARY Change in Hospital Anxiety and Depression Scale for Anxiety (HADS-A) Total Score |
-4.5; -4.2; -5.2; -4.6 | — |
| SECONDARY Change in Psychic Anxiety Symptoms as Measured by HAM-A Psychic Anxiety Factor Score |
-5.9; -5.8; -6.5; -5.8 | — |
| SECONDARY Change in Somatic Symptoms as Measured by HAM-A Somatic Factor Score |
-5.0; -5.3; -5.1; -5.2 | — |
| SECONDARY Change in Sheehan Disability Scale (SDS) Global Total Score |
-4.7; -5.7; -6.8; -6.8 | — |
Eligibility Criteria
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 history of schizophrenia or other psychotic disorders
- Patient has a history of seizures or seizure disorder.
- Patient is pregnant or breast feeding.
- Patient has received electroconvulsive treatment (ECT) in the past.
Data sourced from ClinicalTrials.gov (NCT00808249). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.