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

Study Overview
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Brief Summary
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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
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A Multi-Center, Randomized, Placebo-Controlled, Double-Blind, Parallel Group, Efficacy and Safety Study of AZD7325 in the Treatment of Generalized Anxiety Disorder (GAD)

Conditions
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Anxiety Disorders

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


Participation Criteria
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Eligibility Criteria
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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
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A-AZD7325 2mg<br>AZD7325 2mg BID | Drug: AZD7325<br>* 2 tablets taken twice a day for 28 days<br>|
| Experimental: B-AZD7325 5mg<br>AZD7325 5mg BID | Drug: AZD7325<br>* 2 tablets taken twice a day for 28 days<br>|
| Experimental: C-AZD7325 10mg<br>AZD7325 10mg QD | Drug: AZD7325<br>* 2 tablets taken twice a day for 28 days<br>|
| Experimental: D-Placebo<br>Placebo | Drug: Placebo<br>* 2 tablets taken twice a day for 28 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in the Hamilton Rating Scale for Anxiety (HAM-A) Total Score | 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. | From 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 | The HADS-A is a 7 item, self administered instrument to measure level of anxiety. Each item is a score rate from 0 (happens rarely ) to 3 (happens frequently), and the items are totaled for a maximum score of 21. The mimimum score 0 indicates that the patient rarely suffered from anxiety symptoms. | From randomization (baseline) to week 4 | 
| Change in Psychic Anxiety Symptoms as Measured by HAM-A Psychic Anxiety Factor Score | The HAM-A psychic anxiety factor score is calculated as the sum of 7 HAM-A individual items related with psychic anxiety ( each rated from 0 to 4, 0 is the best). The minimum score for HAM-A psychic anxiety factor is 0 and maximum score is 28, higher score indicates severe psychic anxiety symptoms. | From baseline (randomization) to week 4 | 
| Change in Somatic Symptoms as Measured by HAM-A Somatic Factor Score | The HAM-A somatic factor score is calculated as the sum of 7 individual HAM-A items (each is rated from 0 to 4, 0 is the best) related with somatic anxiety symptoms. The minimum score for HAM-A somatic factor is 0 and maximum score is 28, higher score indicates severe somatic anxiety symptoms | From baseline ( randomization) to week 4 | 
| Change in Sheehan Disability Scale (SDS) Global Total Score | The Sheehan Disability Scale is a patient-rated measure of functional disability in 3 subscales: work, social, and family life. Each subscale is rated from 0 to 10, with 0 as the best. SDS global total score is calculated as the sum of 3 subscales and ranges from 0(unimpaired) to 30 (highly impaired) | From baseline ( randomization) to week 4 | 

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