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

Phase 2

Completed

• Conditions: Anxiety Disorders
• Interventions: Drug: AZD7325; Drug: Lorazepam; Drug: Placebo

• Registration Number: NCT00807937
• Lead Sponsor: AstraZeneca

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-12
• Study First Submitted: 2008-12-12
• Study First Submitted QC: 2008-12-12
• Study First Posted: 2008-12-15
• Primary Completion: 2009-05
• Study Completion: 2009-05
• Results First Submitted: 2010-07-29
• Status Verified: 2010-09
• Results First Submitted QC: 2010-09-16
• Last Update Submitted: 2010-09-16
• Results First Posted: 2010-10-08
• Last Update Posted: 2010-10-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 369

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B	AZD7325	AZD7325 15mg twice daily
C	Lorazepam	Lorazepam 2mg twice daily
D	Placebo	Placebo
A	AZD7325	AZD7325 5mg twice daily

Primary Outcome Measures

Name	Time	Method
Change in the Hamilton Rating Scale for Anxiety (HAM-A) Total Score	Baseline to week 4	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

Secondary Outcome Measures

Name	Time	Method
Change in Hospital Anxiety and Depression Scale for Anxiety (HADS-A) Total Score	Baseline to week 4	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
Change in Psychic Anxiety Factor as Measured by HAM-A Psychic Cluster Score	Baseline to week 4	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
Change in Somatic Symptoms as Measured by HAM-A Somatic Cluster Score	Baseline to week 4	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.
Change in Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q-SF) Percent Maximum Total Score	Baseline to week 4	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

Trial Locations

Locations (1)

Research Site; 🇺🇸 Seattle, Washington, United States