Phase 2
Completed N=369
Proof of Concept in Patients With Generalized Anxiety Disorder (GAD)AZD7325
Source: ClinicalTrials.gov NCT00807937 ↗Enrolled (actual)
369
Serious AEs
0.0%
Results posted
Oct 2010
Primary outcomePrimary: Change in the Hamilton Rating Scale for Anxiety (HAM-A) Total Score — -10.1; -10.4; -10.8; -9.5 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 in the Hamilton Rating Scale for Anxiety (HAM-A) Total Score |
-10.1; -10.4; -10.8; -9.5 | — |
| SECONDARY Change in Hospital Anxiety and Depression Scale for Anxiety (HADS-A) Total Score |
-5.0; -4.9; -5.0; -4.5 | — |
| SECONDARY Change in Psychic Anxiety Factor as Measured by HAM-A Psychic Cluster Score |
-5.5; -5.7; -6.0; -5.1 | — |
| SECONDARY Change in Somatic Symptoms as Measured by HAM-A Somatic Cluster Score |
-4.5; -4.7; -4.9; -4.3 | — |
| SECONDARY Change in Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q-SF) Percent Maximum Total Score |
7.79; 9.04; 7.46; 6.95 | — |
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 (NCT00807937). 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.