Proof of Concept in Patients With Generalized Anxiety Disorder (GAD)AZD7325

Study Overview
=================
Brief 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.

Official Title
-----------------
A Multi-Center, Randomized, Placebo-Controlled, Double-Blind, Parallel Group, Phase II Study of 2 Oral Dose Groups of AZD7325, With a Lorazepam Arm, in Subjects With Generalized Anxiety Disorder (GAD)

Conditions
-----------------
Anxiety Disorders

Intervention / Treatment
-----------------
* Drug: AZD7325
* Drug: AZD7325
* Drug: Lorazepam
* Drug: Placebo


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>AZD7325 5mg twice daily | Drug: AZD7325<br>* 4 tablets and 1 capsule taken twice a day for 28 days<br>|
| Experimental: B<br>AZD7325 15mg twice daily | Drug: AZD7325<br>* 4 tablets and 1 capsule taken twice a day for 28 days<br>|
| Active Comparator: C<br>Lorazepam 2mg twice daily | Drug: Lorazepam<br>* 4 tablets and 1 capsule taken twice a day for 28 days<br>|
| Placebo Comparator: D<br>Placebo | Drug: Placebo<br>* 4 tablets and 1 capsule taken twice a day for 28 days<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Baseline to week 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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. | 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 | Baseline to week 4 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Generalized Anxiety Disorder, GAD, Anxiety